According to the Art. 110 sec. 3 of the Regulation (EU) 2017/746 as amended (IVDR), devices with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article or devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, and which may be placed on the market or put into service until the following dates:
(a) 26 May 2025, for class D devices;
(b) 26 May 2026, for class C devices;
(c) 26 May 2027, for class B devices;
(d) 26 May 2027, for class A devices placed on the market in sterile condition,
(hereinafter referred to as “legacy devices“), shall meet requirements of this Regulation relating to:
- post-market surveillance,
- market surveillance,
- registration of economic operators and devices
which shall apply in place of the corresponding requirements in the Directive.
Therefore, during the IVDD and/ or QMS-MD audit of the manufacturer whom the art. 110 sec. 3 of IVDR is applicable for, Audit Team shall verify the conformity of the manufacturers QMS-MD and/ or device with the following requirements:
Post-market surveillance (PMS)
· Manufacturer must implement a PMS system according to Article 78 (all mentioned articles are IVDR articles), with the exception of the aspects related to pre-market requirements that do not apply to “legacy devices”, as update of the safety and performance summary (Article 78(3)(d) IVDR),
· PMS system according to Article 83 must be based on PMS plan according to Article 79,
· As part of the manufacturer’s post-market surveillance system, the post-market performance follow-up (PMPF) requirements (Annex XIII, Part B, IVDR) should apply to ‘legacy devices’. That means that, under the IVDR, manufacturers need to “proactively collect and evaluate performance and relevant scientific data from the use of a device”. However, this does not mean that the manufacturer would have to draw up, retrospectively, a performance evaluation report in line with the IVDR as performance evaluation and its documentation according to the IVDR is a pre-market requirement not applicable to ‘legacy devices’.
· As Directive 98/79/EC, contrary to the IVDR, does not provide for rules for the classification of devices in risk classes as specified in the IVDR, an appropriate distinction cannot be made between ‘legacy devices’ to which Article 80 IVDR (PMS report) and ‘legacy devices’ to which Article 81 IVDR (periodic safety update report, PSUR) apply. Therefore, Article 80 IVDR (PMS report) should, as a minimum requirement, apply to all legacy devices, unless a manufacturer of ‘legacy devices’ that will fall under class C or D voluntarily prepares a PSUR pursuant to Article 81,
· Manufacturers must upload reports to the electronic vigilance and post-market surveillance system of the manufacturer according to Article 87 (in the absence of full functionality of EUDAMED, special transitional provisions shall apply in accordance with Art. 112, 113(3)(f) IVDR),
- Technical documentation concerning the PMS must comply with the requirements of Annex III of the IVDR.
· Manufacturer shall be aware of the market surveillance activities of the competent authorities, the Member States and the Commission under Articles 88, 89, 91 - 95
· Manufacturer must have a procedure in place to deal with devices which present an unacceptable risk to health and safety in accordance with Article 90
· Manufacturers must report serious accidents and safety corrective actions in accordance with Article 82,
· Manufacturers must report on trends according to Article 83,
· Manufacturers must carry out analysis of serious accidents and safety corrective actions according to Article 84,
· Manufacturers must be aware of the implementing acts according to Article 86
Registration of economic operators and of devices
· Manufacturers must register their devices in accordance with Article 26 (in the absence of full functionality of EUDAMED, specific transitional provisions apply in accordance with Articles 112, 113(3)(f) IVDR),
· Manufacturers, authorised representatives and importers have to register according to Article 28 (in the absence of full functionality of EUDAMED, specific transitional provisions apply in accordance with Article 112, 113(3)(f) IVDR),
- Manufacturers have to follow the guidance documents on the EUDAMED database, e. g. MDCG 2019-5.
Verification of implementation
Audit Team shall verify during upcoming surveillance audits that manufacturers
· conducted an extraordinary internal audit regarding implementation of applicable IVDR requirements,
· demonstrate an objective evidence of implementation of abovementioned IVDR requirements (documents and records),
· demonstrate competence of the IVDR requirements, e.g. IVDR Training,
· conducted an extraordinary management review to verify implementation of above mentioned IVDR requirements.