MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

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) giving manufacturers of Class I devices upclassified under the MDR a four-year transitional period until May 26, 2024, before they are required to meet the new regulation’s standards.

The corrigendum proposes to modify the text of Article 120(3) from “By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues …” to “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…”.

In addition to this change this 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.

Although it has not yet been approved by the European Parliament, it is in fact expected and desirable that this correction takes effect.

Asphalion attended the second edition of the “Forum d'Empreses de l'ámbit farmacèutic – sanitari“
Marcos Fernández, New Regulatory Affairs Associate Director at Asphalion

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