Second MDR Corrigendum Targets Class I Devices

Regulatory NewsRegulatory News | 26 November 2019 |  By 

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply.

The delay for some low-risk devices was expected as Duncan McPherson, clinical director of devices at the UK’s Medicines and Healthcare products Regulatory Agency, told attendees at RAPS’ Convergence this year that a proposal had been submitted to the European Commission for this second corrigendum to change the timetable for Class I reusable devices, including some software, that are being upclassified.

The corrigendum proposes to alter Article 120(3) by inserting (additions underlined): “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that from 26 May 2020 it continues...”

But Article 120(3) also notes that the requirements of MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those two directives.

In addition, devices lawfully placed on the market pursuant to the device directives prior to 26 May 2020 may continue to be made available on the market or put into service until 27 May 2025, the regulation says. But the corrigendum corrects this later date to 26 May 2025.

This second corrigendum makes further minor edits, corrections and additions to Article 78(8), Article 84, Article 88(1), Article 120(8), Article 122, Annex I and Annex III. And the corrigendum needs to be adopted by the European Parliament to take effect.

The first round of corrigenda, meanwhile, offered further tweaks to MDR and the In Vitro Diagnostic Regulation.

Council of the European Union (English version starts on page 43)


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