Table 5.

Overview on the Requirements Related to LDT Use According to Article 5 (5) of the EU IVDR, Proposed Implementation Methods and Comparison with the General Obligations of Commercial IVD Manufacturers According to Article 10 of the EU IVDR.

No	Requirement for LDT use according to Article 5 (5) of the IVDR	Proposed implementation method for LDTs	General requirement for CE-marked IVD as per Article 10, IVDR
I	(a)the devices are not transferred to another legal entity	LDTs shall be manufactured and used only within a single health institution	Not applicable
II	(b) manufacture and use of the devices occur under appropriate quality management systems	QMS according to ISO 15189 and applicable requirements of ISO 13485	QMS according to EN ISO 13485 and QM requirements according to Article 10, IVDR
III	(c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation	Compliance with ISO 15189 (as shown by accreditation) or with national provisions, for example the RiLiBÄK (Germany)	Not applicable
IV	d) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market	QM documentation of the justification for use of LDTs. Compare Fig. 3	Not applicable
V	(e) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use	QM documentation on the use of LDTs	Technical documentation according to Annex II and III, IVDR
VI	(f) the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution, (ii) the details necessary to identify the devices, (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefore	Documentation and publication of a formal declaration of conformity with Annex I, IVDR	Draw up of an EU declaration of conformity in compliance with Article 17 and Annex IV, IVDR
VII	(g) as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII	Documentation of the design, performance evaluation data and manufacturing process within the laboratory’s QM system	Technical documentation according to Annex II, IVDR
VIII	(h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g)	Continuous documentation of the data related to manufactured LDTs	Technical documentation according to Annex II, IVDR
IX	(i) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions	Implementation of an LDT review system including CAPA procedures	Technical documentation according to Annex III, IVDR
X	Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions	Control of any documents and records of the QM system related to LDTs	Concepts and methods of market surveillance by competent authorities according to Articles 88ff. IVDR
XI	This paragraph shall not apply to devices that are manufactured on an industrial scale	Laboratories shall not offer their service in the frame of an industrial production chain and environment	Not applicable