Global market and supply chain implications of the European Union medical device regulation 2017/745 as amended by 2023/607

Abstract

The release of the European Union Medical Device Regulations (EU MDR) has introduced many complexities for medical device manufacturers and has had implications for their global markets; one such complexity was the unforeseen consequence of the impact which the MDR has imposed on country registrations held outside the European jurisdiction, as certain countries abridge the Conformité Européene (CE) mark for market authorization purposes. This study focuses on the global implications for medical device manufacturers regarding the implementation of the MDR. It discusses whether the amending regulations will influence positive change regarding the MDR transition or introduce any unintended consequences. A regulatory assessment of a large enterprise medical device manufacturer’s global markets was conducted to assess the impact of the MDR on its globally commercialized products. A subsequent qualitative study was carried out with 15 other European based Medtech organizations to benchmark their understanding of the MDR effects on their global products and ascertain what actions, if any, needed to be taken prior to MDR certification. The MDRs has affected the availability of European-manufactured devices globally and has led to increased administration and workload in maintaining product registrations. While only 15 organizations were interviewed, the challenges identified were representative of the EU Medtech community and the global regulatory landscape in which these organizations operated at a point in time pre the amending regulations. This study can help develop key recommendations for manufacturers to consider in their certifications transition to MDR, as well as educating policymakers on the impact of the MDR on the global market and aiding in a lessons learned review by the EU of how the regulations were scoped and deployed in terms of effects on the manufacturers. Understanding the effect and implications of the EU MDRs on global markets will assist in the generation of an appropriate help develop global regulatory strategies, which in turn to ensure that there is no shortage of critical and life-saving devices across all markets. This study is the first of its kind to capture the effects of MDR on European medical device manufacturers’ globally commercialized products and product portfolios, detailing its effects at a point in time. The study has implications for theory and practice: academics can leverage it to understand the MDR from Manufacturing, Supply Chain, and Marketing viewpoints, and European policymakers can use it to take further action and study lessons learned.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12913-025-13907-y.

Introduction

The dynamic nature of the global regulatory landscape for medical devices brings constant challenges for medical device manufacturers. The European Union (EU) is one of the most highly regulated markets for medical devices in the world. The official website of the European Union (2022) has reported that the EU has a population of 447.4 million inhabitants; therefore, enforcing a stringent market authorization process for medical devices in the EU is one of the most pressing concerns for medical device manufacturers located in the EU and also who import devices into the EU is a regulatory priority. The release of the Medical Device Regulations (MDR) 2017/745 (2017) has changed the process brought the Medtech industry in Europe to a critical crossroads for attaining market authorization, creating an environment of uncertainty, unpredictability, and inefficiencies in the market authorization system [1, 2].

To commercialize a medical device in Europe, a manufacturer must first attain a Conformité Européene (CE) mark confirming that the device meets the legal governing regulations and or directives required to demonstrate the safety and performance of the device based on the law [3].

As well as adhering to EU regulations, manufacturers must keep abreast of regulatory changes in emerging markets.These changes can have commercial implications for the manufacturers; therefore, the dissemination of regulatory intelligence as it evolves is important for compliance [4].

Countries or jurisdictions outside Europe that abridge or rely on the CE mark to support or speed up the market authorization process will be affected by the MDR [5, 6]. Abridgement refers to streamlining the assessment process for including these devices in regulatory registers, whereby one authority accepts or relies on the regulatory approval gained in another jurisdiction [7]. It is also a form of regulatory reliance [8]. It has been defined by the World Health Organisation (WHO) as “the act whereby a regulatory authority in one jurisdiction may take into account/give significant weight to work performed by another regulator or other trusted institution in reaching its own decision” [9]. If the CE mark is a mandatory prerequisite for tenders and for registering the device prior to commercialization, the MDR impacted registrations [10–12]; and affected manufacturers’ conformance with the quality management standard for medical device manufacturers, ISO 13485, as well as the manufacturers’ ISO 13485/Medical Device Single Audit Program (MDSAP) scope, and any design changes invoked as a result of the MDR, could have triggered registration changes [13].

This study focuses on the global implications for medical device manufacturers regarding the implementation of the MDR. It discusses whether amending MDR regulations implemented in 2023 and 2024 will influence the global product portfolios of manufacturers or if the MDR itself introduced any unintended consequences. While there have been studies regarding the increased clinical evaluation requirements under the new MDR [1, 14–16], there have been no peer-reviewed studies related to the impact of the EU MDR specifically on global marketing authorization and device availability. A systematic literature review related to the clinical evaluation requirement of the MDR by McDermott and Kearney [2] in 2024 found sparse detailed research on the MDR other than discussion of the top-level implications of the changes. Manufacturers needed to prepare a global regulatory and commercial strategy in terms of MDR transitioning, supporting business continuity while continuing to maintain customer satisfaction [17, 18]. The changes enforced by the MDR 2017/745 could not be considered in isolation when defining a global transitional plan, as there are numerous supply chain and certification interdependencies, which this study will discuss. This study will fill a gap in the literature assessing MDR impact specifically from a commercial impact (of which there are no studies) rather than a clinical impact, which other studies, such as those by McDermott and Kearney [1, 2, 13, 14] focused on.

The research questions (RQs) are

RQ1:

What are the supply chain and regulatory strategy considerations for medical device manufacturers pursuing MDR 2017/745 certification and as a result of the 2023 amending regulation?

RQ2:

What were the key factors for the development of a regulatory and commercial strategy in supporting the MDR 2017/745 transition?

In order to answer the RQ’s a regulatory assessment of a single medical device manufacturer’s global market was conducted to evaluate the impact of the MDR on its commercialized products. A qualitative interview study of 15 other Medtech organizations was subsequently completed to ascertain their understanding of the MDR’s effects on their global products to establish what actions they needed to take at that time.

Section “Literature review” outlines the literature review and background, section “Methodology” discusses the approach taken, and section “Results” and “Discussion” present the results and discuss them. section “Conclusions” summarizes and discusses the RQs and concludes.

Literature review

Implications of the MDR on European medical device manufacturers

During the MDR transition, a clear global commercial and marketing strategy takes into account potentially removing products not transitioning to the MDR [1, 19].

Migliore [20] outlines that some of the implications of the transition to the MDR were a delay in market access and a reduction in innovative products on the market. This can affect small to medium-sized enterprises (SMEs), which do not have the finances and/or skill set to meet the new MDR requirements [1, 2]. Maresova et al. [21] report that a survey on global innovation found that only 4.4% of New Product Development (NPD) projects are from larger companies, with 9.3% from SMEs, and that, out of the 25,000 MedTech companies in Europe, 95% are SMEs. There were concerns that the release of MDR would result in significant cost and administrative burdens for medical device manufacturers hindering the development of new products, which can restrain innovation [21, 22].

Baines et al. [18] published results surrounding the barriers among innovators, notified bodies (NB’s), and other stakeholders from the MDR. Some of the key findings identified are that the MDR transition impacts SMEs due to the impact of re-classification, heightened scrutiny of clinical evidence where real-world data is not acknowledged, and the additional cost associated with the use of consultants to interpret the requirement and deliverables correctly due to the absence of in-house expertise. Kearney and McDermott [15] outline that addressing the gaps in clinical evidence for legacy devices were challenging and emphasize the importance of having a robust post-market surveillance system to assist in plugging gaps in clinical evidence. Some customers outside the EU lost device products due to product rationalization initiatives conducted by manufacturers under the MDR program, resulting in reimbursement concerns [5]. Reimbursement, in the context of medical devices, is the payment by an insurer or ‘payer’ for the costs a healthcare provider incurred in using a medical device or in performing a procedure [23]. Companies are required to conduct specific clinical trials, which can be expensive and take some time for the devices to be eligible for reimbursement. Thus, with the medical device reimbursement approved, the healthcare provider is able to offer new technologies to patients and this enables commercial expansion of the product for the manufacturer.

For example, the European Association of Pediatrics (EAP) (2023) outlines that the MDR transition has resulted in significant unexpected costs for medical device manufacturers. The EAP outlined a case where one company received invoices pertaining to conformity assessment of a single device in excess of €800,000, which already had 5 years of market access. The cost of this company’s MDR application is documented as over 150 times more expensive than attaining clearance for the same device in the United States. The device in question is only indicated for a specific condition in children, which meant that the revenue from the device would not cover the regulatory cost associated with a MDR application. If a manufacturer is a SME, there can be clinical trials costs to absorb in the design and development phase of the product lifecycle [24]. In essence, some SME manufacturers did not have the funding available to support the application, resulting in the removal of critical medical devices from the EU market [11]

Once the commercial strategy is mapped out for the MDR products, the Medtech organization’s Regulatory Affairs (RA) department must complete a comprehensive regulatory strategy [6]. This strategy outlines the specific timelines for completing parallel global registrations of MDR products. Considerations for national differences must be outlined as part of global registration activities, e.g. in the cases of electrical medical requirements governed under the International Electrotechnical Commision (IEC) 60,601–1 series of standards, there are national differences for various countries such as Nationally Recognized Test Laboratory (NRTL) mark requirement for US and Canada [25]that need to be accounted for in the regulatory and commercial strategy timeline [26]. The new increased requirements for clinical evaluation data in the MDR have been the source of extra regulatory burden to meet the MDR requirements [1, 15, 21]. The clinical function is involved in the generation of the clinical evaluation data required for the associated MDR technical file applications and this generation can be in-house or outsourced [15]. In a study on the clinical evaluation challenges under MDR, Kearney and McDermott [1] found that 50% of SMEs surveyed responded that they outsource their Clinical Evaluation Report (CER), compared to 18% for larger company respondents. They also found that 42% of respondents in the high-risk device category had invested significantly in clinical evaluation training compared to just 10% of respondents in the medium-risk category, as the clinical evaluation for higher-risk devices is subject to greater scrutiny by the notified body and, for certain devices, by an expert panel. Establishing sufficient clinical data to demonstrate device equivalency will increase MDR approval timelines and there are significant financial savings to be had should a manufacturer decide not to complete clinical investigations for low margin devices. [16]

The global authorizations impact of the changing regulatory landscape in Europe

Under the provisions of the MDR 2017/745, market authorization for medical devices in the EU is more complex than ever; the complexity increases significantly based on the device’s risk profile and associated classification [27]. Apart from impacting the EU, the MDR will also have far-reaching consequences outside the EU jurisdiction, especially for those countries that currently abridge the CE mark or Certificates of Free Sale (FSC) for tender or market authorization purposes.

Sell-off provisions and item rationalization

One of the pressing challenges facing the device industry was the transitional provisions under the MDR, which allowed products placed on the market under the Medical Device Directive (MDD) to remain in circulation until 26 May 2025. On 20 March 2023, Regulation (EU) 2023/607 entered into force. This Regulation extended the transitional provisions of the MDR as follows [28]:

• 2026 for class III custom-made devices,

• 2027 for class III and class IIb implantable devices,

• 2028 for other class IIb, class IIa and class Is, Im devices, and

• 2028 for class I up classified devices.

The Regulation also removed the ‘sell-off provision’ for both the MDR and In-vitro diagnostic regulation (IVDR). This means that devices already placed on the market could continue to be made available or put into service until the revised expiry of the certificate or until the shelf life of the device. The scope of applicability of transitional MDR, therefore, hinges on products and “placing on the market” strategy [5]. Article 2 (35) defines an economic operator as a manufacturer, authorized representative, importer and distributor or the person referred to in Articles 22 (1) and 22 (3). All economic operators in the production and distribution chain needed to understand when their respective products are “placed on the market” [29]. This allowed contracts to be drawn up between economic operators regarding sell-off provisions and regulatory responsibilities to ensure business continuity was maintained while MDR certification was being pursued. Upfront transparency regarding sell-off provision, placed on the market and item rationalization needed to be shared by manufacturers with their economic operators in addition to importers and distributors for countries who abridge the CE mark for market authorization. Binkert et al. [30] outline that removing devices with small profit margins, including devices with niche indications or orphan devices, due to the uncertainty surrounding MDR certification, had become a preferred option for some manufacturers. The MDR resulted in significant costs for economic operators as compared to the cost of implementing the MDD [27].

Implications of the re-classification of devices

Re-classification of devices under MDR had an impact on global registration. Hanoğlu et al. [31] discussed the significance of re-classifying non-invasive brain stimulation devices to class III and the implications of this classification change in Turkey. The re-classification of these devices, although for valid increased safety and minimization of patient risk was anticipated to cause market disruption and use limitations due to the narrowing of the intended purpose statement due to insufficient clinical or scientific data. Therefore, patients who previously used this device for different purposes saw limitations of use being placed on the device while being assured of enhanced clinical safety.

Another example was the challenge associated with classifying standalone software as a medical device. The predetermining factor is whether a manufacturer must decide that the software’s intended purpose falls within the definition of a medical device. Pashkov et al. [15, 22, 32] outlined that the new classification rules associated with the software would result in higher development costs due to the level of testing required to demonstrate conformance to the general safety and performance requirements of the MDR and the certification process with the respective NB. It must also be noted that for low-risk software, that NB involvement may not have been required in the past; however, this changed under MDR [2, 33].

Global market authorization implications

Tata [34] published an article outlining 7 ways the EU MDR would impact the Global Medical Device Industry. One of the main areas outlined related to the regulatory uncertainty in non-EU countries such as Mexico, Russia, and Australia, which predominantly rely on the CE mark. The concern in this regard relates to the submission documentation deliverable required for registration, whereby the nuances of MDR have prompted the generation of a suite of new technical file documentation. Therefore, the manufacturer may not be able to use one centralized documentation package as local authorities may reject it.

Another consideration is the implications on global manufacturers outside the EU who intend to get their products certified under the MDR. Article 11 of the MDR requires manufacturers who are based outside the EU to appoint an Authorised Representative (AR). The duties of an authorized representative are predominantly associated with ensuring a manufacturer has completed and maintained conformity assessment procedures to support the safety and performance of the device, in addition to helping manufacturers in vigilance activities [35]. All these activities infer additional costs and complexities for manufacturers. For some, it will not be feasible to absorb these costs, resulting in a change in a commercial strategy that focuses on markets with less arduous regulatory requirements outside the EU.

There are also questions regarding how countries outside the EU manage medical device supply distributions due to the MDR transition. For example, Australia’s current regulatory structure for medical devices aligns with the EU MDD. The Australian competent authority [36] acknowledged that the MDR will impact the supply of medical devices coming from Australia, as the EU won’t accept Australian Conformity assessment any more, resulting in a set of measures being put in place to minimize supply distribution. These measures included: aligning regulatory requirements as much as possible with those of the EU MDR, reducing fees for Australian sponsors seeking approval of EU MDR-certified products in Australia, and streamlining the process to achieve this.

Malaysia is another country that abridges the EU CE mark as part of its market authorization process. The Medical Device Authority (MDA) [37], the governing regulator for devices in Malaysia, announced pre MDR implementation that the MDA will accept expired MDD certificates as part of their conformity assessment procedure. However, this was subject to certain conditions to be verified during the conformity assessment process. These conditions included the device complying with the MDD and Active Implantable medical device directives (AIMD), no significant change to the intended purpose or design of the device, and the device must not have presented an unacceptable risk to the health or safety of the patient, public health, or users [37].

At the end of 2022, TEAM-NB issued a survey consisting of data from 33-member states reporting that while there has been an increase in MDR applications between 2021 and 2022, 55% of current MDD device applications were still to be received at that time. The survey also highlighted a significant area of concern, which was that approximately 3400 MDD certificates were expected to expire in 2023 [38]. Thus, manufacturers needed to attain MDR certification by 2023 or face the consequences from an EU and global perspective of not having a valid CE certificate or supporting FSCs. The survey also indicated that by the end of the transitional period in May 2024, 11,783 MDD certificates would expire.

However, in May 2024, the European Commission published the results of their 8^th survey conducted with data available as of February 2024 on MDR and IVDR certifications and applications. As of Feb 2024, just 45 notified bodies were designated under the Regulations. Between February 2021 and January 2024, MDR notified bodies received just over 20,424 applications and issued about 6.978 thousand product certificates and over 10 thousand Quality Management system (QMS) certificates. Over the same time, the number of applications that IVDR notified bodies received went from 249 to 1.51 thousand, while the number of certificates issued passed from seven to 702 [39].

Summary of the current situation and gaps

On the 09th of December 2022 at the Employment, Social Policy, Health, and Consumer Affairs Council (EPSCO), several legislative reform proposals were put forth by the members of various stakeholders [40]. The proposals included an extension of the transitional period for Article (120), with a risk-based timeline applied based on the device’s classification: 2027 for class III and class IIb devices, 2028 for class IIa and class I devices, and the abolition of the sell-off provisions under Article (120) (4).

The implications of the amending regulation on global markets that abridge the CE mark for market authorization purposes or tenders are critical. The expiration of MDD certificates and the subsequent inability to provide certificates of free sale would have led to global market disruption, resulting in the removal of devices and the loss of market position. However, there was at the time pre-MDR transition concern that authorities in a third country may not fully understand or acknowledge the amending regulation transitional provisions. The MDD EC certificates and FSCs for MDD are not being re-issued and, therefore, displaying an expired date would cause supply issues. MedTech Europe (2023) published a position paper outlining the vision of the future of the medical technology framework in Europe. The paper discussed proposed solutions to address the structural issues with the MDR, emphasizing creating an environment where innovation is fostered while achieving and maintaining the intent of the legislative framework. This can be achieved by establishing clear pathways for product certification, which is essential to sustain product continuity in the EU market. Secondly, embracing innovation needed to be a focus in future framework deliverables, ensuring patient access to innovative devices in Europe. Lastly, Medtech Europe outlined the importance of having effective governance and assigning accountability for driving and maintaining the healthcare ecosystem in Europe and its success globally.

Methodology

Global regulatory commercialization assessment

In order to understand the global impact of the new MDR, a large enterprise medical device manufacturer with a global base was utilized as a single case study example to assess the impact of the MDR on its commercialized products. As there is limited literature assessing the global impact of the MDR, leveraging one medical device company as a case study example and assessing the impact of MDR on its products was an important empirical example. While the results are specific to this one company the MDR effects can be benchmarked and extrapolated in terms of the case studies generalisability [41]. Companies in highly regulated environments can be secretive and protective of information that they fear may give competitors an advantage [42]. A case study organization was useful as a benchmark to demonstrate the global reach and effect of the MDR on one particular manufacturer and gather “real” data [43]. The products of Company X are sold globally, and a regulatory commercialization assessment was issued to countries where Company X (an Electro Medical Device Company) has commercially available products. The assessment was issued to countries where the CE mark has been used as an abridgement for registrations or where the CE mark is required as a mandatory pre-requisite for market authorisation.

The survey focused on four key topics, CE marking, Abridgement, QMS and Design Changes. As mentioned in section “Introduction”, abridging refers to the process of transitioning from the previous MDD or AIMDD to the MDR [7]. A further set of questions were asked in relation to the effect the change in ISO 13485/MDSAP scope might have as a result of the MDR and if design changes as a result of the MDR will impact or trigger registration changes [13].

The assessment questions were answered using in-country agents/licence holders or regulatory professionals appointed by Company X. The assessment was conducted before the release and implementation of the amending EU regulation 2023/607 to extend the introduction of MDR for some devices and before the introduction of amending regulation 2024/1860 which allowed for monitoring and notifications of device shortages and removal from the market. The sample size of 18 for the qualitative study was deemed appropriate as this is the number of global countries where Company X’s products are commercially available and that have abridged the EU approval for in-country market authorisation. The questions utilized in the global product commercialization assessment are outlined below in Table 1.

Table 1.

Questions issued for the MDR global commercialization assessment

Questions:
CE Mark Is a CE mark required for market authorization in your country?
Are FSCs (Certificate of Free Sale) issued by the Irish Competent Authority of Ireland (HPRA) required for market authorization in your country? Note** The Health Products Regulatory Authority (HPRA) has confirmed that FSCs are only issued for CE-marked devices. FSC are also used as evidence of the country of origin of the manufacturer
Would there be any impact in your country if the CE mark was removed from marking from the product labelling?
Does having a CE mark reduce the timeline for product registrations in your country?
Abridgement Are abridgement registrations (US/Canada/Brazil/Japan and Australia) permissible as an alternative to CE marking in your country? If “Yes”, please specify which abridging registration is permissible and if there are any conditions associated with this strategy.
If an abridgement registration is permissible, what additional documents are required to support any change notifications to the regulatory agency?
What is the projected timeline associated with this type of change?
While the registration activity is ongoing, can we continue importing products?
Once the change notification is complete, can we continue depleting inventory at our distribution centres in your country?
QMS It is anticipated that as part of the MDR 2017/745 transition, the current ISO 13485/MDSAP certificate will change scope. Will this change trigger any registration activities in your country? If “Yes”, please specify the type of registration activities ((e.g., change notification, prior approval, or registration amendment)
MDR 2017/745 product The organization’s commercial strategy will determine the registration of MDR products. Some design changes are expected to be implemented to products as part of the MDR update. These updates are currently being finalized, but they may include the following: a. Intended purpose/Intended use changes. b. Label changes c. Instructions for Use changes d. Material changes e. Changes to the design of the product. For the proposed changes above, please advise on registration activity which will be triggered (e.g., change notification, prior approval, or amendment) Please also advise on projected timelines of approval for such changes.
While the registration activity is ongoing, can Company X continue importing products?
Please advise on specific in-country testing which will be required?

Qualitative interview study

Having performed a global product regulatory assessment on Company X, the results were merged with the literature results to devise a set of interview questions to be completed with key stakeholders in the medical device sector. Qualitative research can provide valuable and rich data in terms of people’s opinions to aid understanding of a topic [44, 45].

The purpose of the interviews was to explore in more depth if the findings of Company X’s global product regulatory assessment align with what other industry stakeholders have observed within their global product portfolios and markets. The participants selected represented a broad spectrum of senior stakeholders within Ireland’s MedTech industry. Ireland has a successful MedTech cluster, is the second-largest European exporter of medical devices, and has the largest net surplus of exports in Europe [32]. The participants included individuals from competent authorities, notified bodies, top management in medical device organizations, owners of consultancy companies heavily involved in MDR and regulatory specialists within organizations. They were selected based on their membership of the Irish Medtech Association and their ability to answer the research questions as manufacturers and regulators. The questions were forwarded to the participants, and then they were followed up with virtual conversations, as this mode was more flexible [46]. The ethics of the study were explained, and participants were guaranteed anonymity and the right to withdraw at any stage [47]. Some participants would have had greater exposure than others towards implementing the amending regulation 2023/607, which at the time of the study was the only amending regulation implemented. A list of stakeholders and titles held is outlined in Table 2 below.

Table 2.

Participants for the interviews

Number	Stakeholder	Position held (if provided)
1	Competent Authority	Medical Officer
2	Notified Body	Business Development Officer
3	Multinational	Principal Regulatory Affairs(RA)
4	Small Medium Enterprise	Principal RA
5	Regulatory Consultancy Agency	Company Owner
6	Multinational	Principal RA
7	Multinational	Director of RA
8	Notified Body	Business Development Officer
9	Multinational	Sr RA Specialist
10	Small Medium Enterprise	Director QA/RA
11	Small Medium Enterprise	Sr RA Specialist
12	Multinational	Sr RA Specialist
13	Regulatory Consultancy Agency	Company Owner
14	Multinational Corporation	RA Manager
15	Small Medium Enterprise	Sr QA/RA Director

Appendix A shows the questions issued to the industry stakeholders developed by this study’s authors. These questions were based on a mixture of the concerns highlighted in the literature reviewed, both from the available peer-reviewed literature and industry group surveys and white papers.

The sample size (n = 15) for the qualitative study was deemed appropriate based on the mix of industry stakeholders who participated. After 12–13 interviews, the sample was becoming saturated, and no new themes were emerging [48]. The participants’ level of expertise and experience was deemed appropriate to provide comprehensive insight into the MedTech industry in terms of the current and future status of the EU medical device legislative framework.

Results

Key findings from global commercialisation assessment for Company X

The overall results are presented in Table 3. The following sections will discuss the 5 thematic areas related to operating globally for company X that the MDR was deemed to affect. There were revenue effects if the implications of the MDR assessment are not understood and mitigated against in Company X as part of their global regulatory strategy.

Table 3.

Results of Company X’s global regulatory assessment

CE marking requirements

The assessment found that 14 of 18 global markets in which Company X operates require the CE mark as a prerequisite for market authorization. In these cases, the CE mark was either mandatory or used as an initial abridgement to attain market authorization. Based on the transitional provisions outlined in the MDR 2017/475 and Medical Device Coordination Group (MDCG) 2020–3, Company X would no longer be able to apply the CE mark post the 26th of May 2024 to any of its products [49]. Removing the CE mark would impact on the company’s global revenue stream; therefore, the commercial strategy addressing this concern needed to be carefully defined. Maintaining market position is vital for the company’s reputation, brand, and customers and is essential in mitigating competitor market penetration. Although additional countries may require the CE mark or an FSC for market authorization; only countries where Company X commercially sold products were included in their assessment for demonstration purposes.

Free sale certificate (FSC) requirement

The results showed that 13 of 18 global markets require a FSC for market authorization; the FSC is used as evidence that the product is CE-marked and is also used for country-of-origin evidence for the manufacture. Under the provisions of MDR 2017/745, FSCs were not to be issued to medical device manufacturers with an expired CE certificate. In this case, the legal manufacturer is based in Ireland; therefore, FSCs are issued by the competent authority, the Health Products Regulatory Authority (HPRA).

Abridgement of market authorizations

Of Company X’s products that were sold globally and where the products are commercially available, 14 out of the 18 countries assessed were identified as abridging EU approval in some regard to support market authorizations (Table 4).

Table 4.

Countries requiring abridgement

Country	Country
Australia	Malaysia
Saudi Arabia	South Africa
Israel	Singapore
Taiwan	India
Ecuador	UAE
Honduras	Hong Kong
Colombia	Vietnam

The global assessment concluded that 13 of 18 global markets surveyed are permitted to abridge market authorizations from other Global Harmonisation Task Force (GHTF) countries where the CE mark has been removed from the product. However, in some of these instances, FSC is still required to assist in market authorization as it is also used to provide evidence of the country of origin. Furthermore, the complexity of abridgement is additionally complicated as the EU product portfolio is the most mature jurisdiction in the company’s global footprint. Thus, if abridging without an FSC is permissible, this was deemed to have commercial, customer, regulatory, and operational implications. Abridgement must mirror the country’s approval or clearance; for instance, if abridging a 510 (k) clearance and US Certificate of Foreign Government (CFG), the product offering for the system is not identical to what is currently CE marked. It is important to note that electrical medical devices are subject to country-specific nuances, which can lead to additional testing and/or specific labelling nuances, further complicating abridgement opportunities.

ISO 13485 scope impact change

The assessment concluded that the change in the scope of the ISO 13485 certificate would impact 8 out of 18 global markets of Company X. The response did not articulate the regulatory implications (whether this was a notification of change or prior approval). When the assessment was conducted, it was unknown at the time as to what the actual difference would involve.

MDR implications for company X summarised

Company X cited the “crippling provision” of the MDR as the “sell-off” provision of legacy devices. Pre-the 2023 amending regulation in the case study organization, the requirement of the “sell-off” provisions for Company X ensued in the meticulous management of contract negotiations with distributors and had implications for the supply chain regarding inventory management. Company X held a valid MDD certificate expiring on 26th May 2024; and under the 2023 amending provisions, the validity of this certificate for class IIa devices was extended until the 31st of December 2028. The extension of the MDD certificate indirectly infers that the MDD FSCs will also remain valid until the 31st of December 2028, therefore allowing Company X to manage the MDR transition strategically to limit market disruption and impact on the current and future customer base.

The 2023 amending regulation permitted Company X to adequate time to analyze the global market commercially and accurately forecast the return on investment in the registering MDR-certified product. Company X had to decide as to whether to make changes to global market portfolios, bringing some products to end of life and changing the global registration strategy for the MDR products.

At the time of this study the 2023 amending regulation has also been acknowledged in countries like Australia, the UK, and Switzerland, which were strategically crucial markets for Company X. However, there is also an acknowledgement that the changing regulatory landscape in these countries with the release of new regulations must be carefully monitored and adhered to, mitigating commercial implications. Regulatory intelligence monitoring and dissemination are critical in this regard for Company X. The amending provisions of 2023/607 allow for Company X to sell MDD-certified and MDR-certified products to be sold concurrently on the EU market. However, this is only permissible if the validity of the MDD certificate continues to meet the amending provisions. Maintaining EU MDD and MDR-certified products on the market has increased audit costs, which have had to be incorporated into the annual budget.

Qualitative interview results

Question 1:

Having shared the global regulatory assessment findings from Company X’s global market with you, are they aligned with what you or your organization have observed or identified globally during the MDR transition?

Ten of the 15 organizations interviewed stated that the findings from Company X’s assessment aligned with their own experiences and/or were identified during their organization’s MDR transition. Three interviewees outlined that the products in their organizations were not globally commercialized in most of the markets identified in the Company X assessment but are available in the US, Japan, and the EU.

Question 2:

Are there any findings from the Company X assessment that require additional exploration from an industry perspective?

A total of 11 of the 15 participants interviewed stated that some of the findings identified in the global product assessment required further exploration from an industry perspective. Considerations regarding nuances requiring additional investigation included the global implications of a change in ISO 13485 scope, the international significance regarding software reclassification, abridgement implications of using other market approvals and the additional resourcing required to deal with the global implications of the MDR. The participants also acknowledged the implications from a global perspective on how expired EC certificates still valid under the amending regulation 2023/607 would be interpreted and accepted by international markets. This amending regulation 2023/607 was released in March 2023. Therefore, many global market locations were trying to understand the implications and revise their internal country regulations or policies to accommodate the acceptance of expired EC certificates.

Question 3:

Do you believe the EU Commission has given due consideration to all types of devices, irrespective of class or classification, in terms of the broader global implications for medical device manufacturers due to the MDR transition?

In total, 14 out of the 15 participants believed that the EU Commission had not given due consideration to all types of devices, irrespective of classification regarding the global implications of the MDR transition. Six of the 14 participants cited the consideration for global markets as the central concern. Issues regarding the acknowledgement of expiring certificates and whether abridgement is permissible were highlighted in the responses. Others cited the implications for orphan devices in treating rare, life-threatening conditions and said that the EU Commission has not adequately provided a clear regulatory framework for these devices. The need for more consideration as to how the MDR transition will impact innovation in the EU was also outlined. Overall, there is a consensus that communication and considerations for the true implications of MDR are fragmented, and the current framework does not consider these pressing concerns echoed by MedTech stakeholders. One of the respondents believed that the amending regulation 2023/607 is sufficient to address the concerns of the manufacturer. Another respondent outlined that the extension is relative to the device classification, and the lower the classification of the device, the less stringent the technical documentation deliverables, which is a fair and justified approach and lifts the burden on the industry.

Question 4:

Will the implementation of Regulation 2023/607 address all the concerns identified in the assessment?

In total, 14 of the 15 participants surveyed do not believe that amending regulation 2023/607 would address all the impacts outlined in Company X’s assessment. Nine out of the 14 participants stated that amending regulation 2023/607 will not address global problems, such as the acceptance of expired certificates by third countries, which at the time of this study was unclear. Other participants outlined that the amending regulation only addressed the short-term bottleneck by extending compliance timelines to address capacity issues but does not address long-term implications. For example, one respondent stated that good products were leaving the EU due to the cost of remediation in terms of clinical data and the extensive documentation deliverables to support GSPR deliverables.

Question 5:

Do you foresee the implementation of Regulation 2023/607 evoking any unintended or unforeseen consequences for the medical device industry? If so, please elaborate.

In total, 13 out of the 15 participants stated that the amendment of the regulation would have unintended consequences for the medical device industry. Four participants outlined that due to the abolition of the sell-off provisions and the extension to the complaint timelines, manufacturers will refocus efforts on innovation for other justifications. Therefore, they believe the same capacity issued by the NB’s pre-amendment will be experienced again towards the end of the transitional provisions, thus “pushing the issue down the road”.

Interestingly, two participants outlined a vigilance issue, where a manufacturer may have MDD and MDR-certified products on the EU market simultaneously. Issues may arise when the MDR product has different indications and electronic Instructions for Use (IFU), and the MDD product has a paper-based IFU with tighter indications. These issues may arise if the same physician uses both products and an adverse event occurs, for example, during the MDR transition because the device’s manufacturer changed Notified Bodies. This adds a layer of complexity, and how this type of situation will be managed is still being determined.

Discussion

The research questions of the study will be discussed in detail; these were that the study establish:

RQ1:

What are the supply chain and regulatory strategy and considerations for medical device manufacturers pursuing MDR 2017/745 certification and amending regulation 2023/607?

RQ2:

What are the key factors for the development of a regulatory and commercial strategy in supporting the MDR 2017/745 transition?

RQ1:

What are the supply chain and regulatory strategy implications and considerations for medical device manufacturers pursuing MDR 2017/745 certification?

The research demonstrated that there was non-uniformity in manufacturers’ understanding of the global implications imposed by the MDR at the time of the study. The MDR has many supply chain implications, with many complexities and interdependencies. Based on the available literature, the current standing implications of the 2023 amending regulation were reviewed and included in the context of the qualitative study.

Regarding the implications of changes deemed significant under the transitional provisions of Article (120), there were many. Kearney and McDermott [16]outline that a change deemed significant to the design or the intended purpose of a medical device will trigger an MDR submission. MDCG 2020–3 was released to assist manufacturers in making change determinations. However, the participants mentioned that the guidance needs to include the prescriptive text of the previous Notified Body guidance (NBOG 2014–3); failure to do so could potentially lead to ambiguity regarding change assessment determinations. To mitigate this, there needs to be open and transparent communication between the manufacturer and the Notified Body regarding changes to the device and the quality management system.

The transitional provisions of Article (120) must be clearly outlined to top management and disseminated throughout the organization. Non-adherence to the transitional timelines or misinterpretation of the transitional provisions will be considered a major non-conformance in a Notified Body or Competent Authority audit. Therefore, assigning competent resources to the MDR program is essential for a successful transition.

Global implications

The research identified numerous global implications that the EU Commission should have considered during the implementation of the MDR framework. Item rationalization and project portfolio management are pressing concerns from an EU and international perspective. Binkert et al. [30] outline that removing devices with small profit margins, including devices with niche indications or orphan devices, due to the uncertainty surrounding MDR certification, is becoming a preferred option for some manufacturers. Majety et al. [50]outline that manufacturers should review the product portfolio against the requirements of the regulation and consider the future needs of the business.

As discovered in the discussion with Company X and the qualitative study, European portfolio rationalization will also have implications for global markets that abridge the CE mark or require an FSC for market authorization purposes. Out of the 18 global markets surveyed for Company X, where the products are commercially available, 14 countries stated that they required a CE Mark, and 13 countries required an FSC for market authorization purposes. The significance of the CE mark is relative to the FSC, as the competent authorities will only issue an FSC (evidence of country of origin) for CE-marked products. Therefore, not having a CE mark also impacts the issuance of this certificate. The experience of Company X was substantiated by the industry stakeholders who echoed the findings related to CE mark removal and FSC implications. Ultimately, the main impact of this will be felt at the patient level, where devices previously available to treat life-threatening conditions and orphan devices used to treat rare diseases will no longer be available in the EU and international markets. This impact has already been documented and raised by several stakeholders [1, 32], 51]. If the MDR product has changed substantially in terms of design and claims, then as outlined for Company X, this will trigger prior approval activities. For these activities to be supported in an organization, adequate resourcing must be assigned, and inventory management for the depletion and transfer to MDR products must be carefully managed so as not to overburden the supply chain.

Regarding abridgement opportunities, in Company X, 13 out of the 18 countries that participated indicated that abridgement of Global Harmonisation Task Force (GHTF) approval would be permissible. This is positive news for manufacturers who are fortunate enough to have a commercial footprint in some of these markets; however, as the interviewees and literature review highlighted, market nuances will play a factor. For example, in the case of Company X, the EU market is their most mature market. Thus, if abridging a GHTF registration, then the offering must mirror that specific registration and could result in tightening of indications, impacting customers and patients alike.

Additionally, the abridgement of a GHTF does not incite the issuance of an FSC, which is required by 13 countries to demonstrate evidence of country of origin. Both are unaddressed concerns not explored in current published literature. However, this was highlighted in Company X’s assessment and acknowledged as a concern by interviewees.

Sell off provisions

Another industry-acclaimed crippling provision of the MDR is the “sell-off” provisions of legacy devices [2, 38]. Pre-the 2023 amending regulation, this provision as mentioned previously had supply chain and financial implications for the medtech value chain operators with all certified MDD products required to be “placed on the market” by the 26th of May 2024 and at the end customer no later than 26th of May 2025. Managing these Sell-off provisions required contract negotiations with distributors and had effects on inventory management. When this provision was under exploration for Company X’s initial assessment, there was no guidance regarding the rework of returned devices for circumstances where the design of the product was unchanged between MDD and MDR and where no shelf life was assigned. Nuances like this were not considered by the EU Commission, potentially resulting in the scraping of good products worth millions of euros, which could be detrimental to an organization.

What the EU Commission has done to help manufacturers?

While this research was being conducted; in parallel and since the study’s completion the EU Commission has undertaken some pragmatic steps to assist manufacturers in understanding and applying the provisions of the amending regulation. These steps include:

• In May 2023, the guidance MDCG 2020–3 [49] related to significant changes in MDCG 2020–3 was revised to incorporate the amending regulation 2023/607 of the transitional provisions of Article (120). This revision was completed to assist manufacturers in making change determinations while incorporating the amending regulation provisions.

• In addition, in June 2023, the EU Commission released a confirmation letter template which Notified Bodies can use to help manufacturers. The letter demonstrates that while the certificates and FSCs under the MDD have expired, products were lawfully placed on the market as per the transitional provisions of the amending regulation [51]. This letter is in addition to the manufacturer’s self-declaration letter regarding the MDR amendment. This harmonized approach should alleviate some concerns in third countries that abridge the CE mark or FSC for market authorization. It indicates that the respective Notified Body has a formal agreement with the manufacturer regarding the MDR strategy.

• In July 2023, the EU Commission released a Questions and Answers document related to practical aspects of implementing the amending regulation 2023/607 [52]. One change clarifies that the letter generated by the Notified Bodies about the expired certificate is not considered a withdrawal of certificate and should be used to address third-country requests to ensure continuity of supply and acceptance of legacy products with an expired MDD certificate.

• The EU Commission in 2023 [53] issued a factsheet for authorities in non-EU/EEA states outlining an overview of the implications of the amending regulation regarding the position of MDD CE certificates and Declarations of Conformity regarding the extended validity [53]. At the time Company X completed its global product assessment, amending regulation 2023/607 was not in place, and industry advocacy to the EMA was still in progress.

• Regulations (EU) 2017/745 and (EU) 2017/746, to give manufacturers more time to apply the EU legislation on MD’s and IVD’s without compromising safety requirements was signed into force on the 9^{th of} July 2024. This was adopted to avoid device shortages as the new measures include an “obligation for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals, and economic operators to whom they supply the device” [54].

• The European Medicines Agency (EMA) has launched a pilot for expert panels to support the development and assessment of orphan medical devices in the European Union (EU) [55]. The pilot programme offers free advice from expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation, scheduled to run until the end of 2025 with a view to establishing a long-term process for orphan device support.

RQ2:

What are the key factors for the development of a regulatory and commercial strategy in supporting the MDR 2017/745 transition?

There are many supply chain and regulatory implications for manufacturers because of the MDR. The regulatory impact, in particular has been discussed by many authors [1, 2, 5, 11, 13] in terms of devices being removed from the market due to increased clinical evaluation requirements and delays in getting market authorisation due to increased technical file requirements. However, the effect of manufacturers deciding to adopt a “USA or other region” launch strategy because of the increased bureaucracy of the MDR has had a downside in terms of patient device supply [14, 21, 27]. Manufacturers have the opportunity to document and share lessons that will inform regulatory and supply chain literature going forward. There are some key recommendations and findings arising from the literature review and the Company X assessment combined with the qualitative stakeholder feedback. Initially, the recommendations were based on the MDR before the amending regulations 2023/607 and 2024/1860; however, since the amending regulations were implemented in 2023 and 2024 the significance of the transitional provisions cannot be ignored and, therefore, will be considered in the study’s recommendations. These recommendations, all of which have been acted upon in parallel within this studies timeframe and since the study’s completion, are outlined in Table 5 with the updated actions taken and demonstrate how lessons were learned post-MDR launch.

Table 5.

Lessons Learned/Recommendations for and from the MDR 2017/745 transition as a result of this study

Lessons Learned/Recommendation	Context
1. Analysis and monitoring of medical devices that have been removed or discontinued from the EU market due to the stringent requirements and extensive costs associated with MDR certification. Regulation (EU) 2024/1860 allows for monitoring and notifications of device shortages and removal from the market	It is important to measure and understand any unforeseen patient implications in the EU and globally regarding device removal or discontinuation.
2. The amending regulation (2023/607) failed to address the implications for Innovation or provide guidance on how the MDR will impact medical device innovation in the EU. Data analysis regarding capital investment in medical devices in the EU and the availability of innovative devices in the treatment of life-threatening conditions needed to be further explored. Regulations (EU) 2017/745 and (EU) 2017/746, gave manufacturers more time to comply with EU legislation without compromising safety requirements and avoid shortages.	The amending regulation (2023/607) failed to address the implications for innovation or provide guidance on how the MDR will impact medical device innovation in the EU.
3. Monitoring and product analysis regarding the implementing legislative framework for orphan devices was recommended be explored further, as these devices have a high impact for a specific cohort of patients if these devices are removed from the market. An EU MDCG guidance on orphan medical devices has been published. [56] to aid understanding of clinical evaluation required.	The amending regulation (2023/607) did not address the concerning implications for orphan devices used in the treatment of life-threatening conditions and diseases in the EU market.

Conclusions

The changes enforced by the MDRs should not be considered in isolation when defining a global MDR transitional plan, as there are numerous interdependencies. The narrative surrounding the MDR transition internally in a manufacturer needed to be clearly articulated and disseminated by top management, and the importance of inferring the organisation’s commercial strategy, and the importance of the inference to the organisation’s commercial strategy was considered. Also, in light of recent EU amending regulations, it is important that the EU listen to manufacturers as they have done and review lessons learned in relation to any future regulatory change.

Limitations

A limitation of this study is that it was a “photograph” at a point in time of a single medical device organisation (global market assessment), as well as from the viewpoints of the interviewees and their organisations in that regulatory landscape at that time. It should be noted, as mentioned in the discussion, that certain changes were made at EU level since the study’s completion to address manufacturers’ concerns. Another potential limitation was that this is a single manufacturer case study with its particular product types across a medical device market ranging from low to high-risk devices. However, the case study offers unprecedented insight into the experience of one manufacturer, and the issues faced by them can be extrapolated to understand the MDRs impact. A final limitation is that the study focused primarily on commercial priorities as a gap in the literature rather than clinical priorities, which have been addressed in other literature.

Implications

This study has implications for manufacturers. It is crucial to understand not only the transition to MDR as it was and its far-reaching impact, not just on the market authorization process in the EU. An organization’s global commercial, marketing, and regulatory strategies regarding the MDR transition and future compliance must be considered and enveloped into its overall three-to-five-year strategic plan.

This study also has theoretical implications for both academia and European policy and global regulatory harmonization. Firstly, there was sparse peer-reviewed literature or detailed white papers and still weak regulatory guidance, specifically on the product registration impacts and global marker positioning of MDR products. This study documents the real experiences and opinions of manufacturers related to the implementation of MDR and demonstrates for the literature a detailed effect of political and regulatory change on supply chains. While increasing regulatory scrutiny surrounding the conformity assessment procedures for medical devices whilst projecting patient safety, the EU Commission implemented the regulation without having either the appropriate infrastructure to ensure efficient transition or the governance to support the maintenance of the program. Outside of the EU jurisdiction, it is evident from the research that the global implications for countries that abridge or rely on the EU approval process (EC Certification for CE Marking and FSC) should have been considered, as there was the potential for device removal from the European and global markets. This has had and may still have a significant impact on the commercial revenue stream of an organization but, more importantly, on customers and patients who have relied on these devices for specific clinical indications. All stakeholders should be aware of the aforementioned.

Future research opportunities

Future research opportunities include investigating the implications of the MDR on innovation and the effect on the market for foreign investment in innovative technologies. Further monitoring of this area is essential for the EU to understand the MDR effects and remain a competitive jurisdiction for investment and launch of innovative medical technologies to treat life-threatening diseases. The implications of MDR transition on SME organizations with a limited product portfolio is a further area that should be investigated. Further research in these areas is vital for securing the future of the EU medical device regulatory framework in remaining true to its intent and remaining an attractive market for foreign investors.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Author contributions

T.M., D.B., and O.D. devised the concept, survey, and interview questions, and T.M. and D.B. carried out the methodology research questions. All authors wrote the draft, and O.D. edited the final version.

Funding

No funding was sought or received for this study.

Data availability

Data is provided within the manuscript or supplementary information files.

Declarations

Ethics approval and consent to participate

Informed consent was obtained from all participants in accordance with the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.