Table 3.

Overview of EU-Regulation IVDR 2017/746.

Quality management system	General Safety and Performance Requirements (GSPRs) and technical documentation	Conformity assessment
❒ The requirements for the Quality Management System of the manufacturer are described in Art. 10(8) and involve the following aspects: ❒ verification/validation for business organization, including outsourced processes, design, and development, including production process controls and quality control procedures, post-market surveillance, risk management, and performance evaluation. ❒ Although not yet harmonized with ISO 13485:2016, the new Regulation tries to align with the Standard focusing on a risk-based approach for IVD regulation. Requirements for maintaining a risk management system (refer to Art. 10(2)) differs according to IVD class and must cover the entire lifetime of the device (see Annex I)	Technical Documentation (TD) shall be in compliance with Annexes II and III as per Art. 10(4) in order to provide evidence of conformity with General Safety and Performance Requirements (GSPRs) Compared to the only 5 bullet points of Annex III in the IVD Directive, GSPRs have been extensively revised ❒ Adding completely new requirements with respect to information on device description and specification, design information, analytical performance of the device, stability, software verification and validation, PMS updating requirements to design and manufacturing information, benefit-risk analysis and risk management, performance evaluation	❒ Conformity Assessments Routes have been updated (Art. 9 of IVDD has been replaced by Art. 48 in IVDR) to reflect the new classification rules and subsequent up-classification of most IVDs. ❒ Manufacturers must select an appropriate route to conformity assessment as per Annexes IX to XI. ❒ NB involvement is required in all classes except class A (non-sterile). Class C and D IVDs now require the involvement of EMA and EU reference laboratories (refer to Chapter V, section 2 and Annexes IX, X, XI).
Performance evaluation	EUDAMED-related requirements	Post-market requirements
❒ Performance evaluation is now required throughout the lifetime of the IVD under the explicit requirement to collect and analyze clinical evidence throughout its life-cycle. For this reason, the process of performance evaluation is outlined and performance indicators, that is scientific validity, analytical and clinical performance are clarified. ❒ The requirement for a Performance Evaluation Plan is mandatory. ❒ Artice 10(3) mandates the conduct of performance evaluation based on clinical evidence, including a Post-Market Performance Follow-up (PMPF). ❒ Clinical performance studies are required although some exceptions apply Special provisions for interventional performance studies have been added (refer to Annex XIV)	❒ EUDAMED will be accessible to the public and stakeholders to enhance transparency and traceability. Issue of a Unique Device Identifier (UDI) for traceability in the supply chain is mandatory (refer to Art. 10(4) and 24)	❒ The performance evaluation and its documentation shall be updated throughout the life cycle of the IVD with data obtained from the implementation of the manufacturer’s PMS and PMPF plans (refer to Art. 56(6)) ❒ Annual updates of the PER for class C and D IVDs plans (refer to Art. 56(6)) Incident reporting and trending has become more stringent. Although the current 2-day and 10-day deadlines are retained for the report of a serious public health threat and for reporting a death or serious health deterioration respectively, a new 15-day reporting deadline is introduced for the report of all other serious incidents, replacing the 30-day requirement for reporting all other reportable incidents of the Directive.