News about GMP/cGMP

29.11.2019

EC: Second corrigendum to MDR concerns Class I medical devices

On 25 November 2019, the European Commission published the second corrigendum to the EU Medical Devices Regulation (MDR). The corrections mainly concern Class I medical devices. 

The timetable for these products will be adjusted:

"[…] 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 […]“

This gives manucfacturers of class I products further four years to meet MDR requirements.

Changes and additions can also be found in the following sections:

  • Article 78(8)
  • Article 84
  • Article 88(1)
  • Article 120(8)
  • Article 122
  • Annex I and Annex III.

Medical device manufacturers will find all changes in detail in this document, the English version starts on page 43.


Source:

EC: MDR Corrigendum 13081/19 (English version from p.43)



Comments

No comment has yet been written about this news


Write your comment about this news