MDR: Corrigendum 2

The EU Commission has published the second corrigendum for MDR, which was published in the Official Journal of the EU on 27.12.2019 and is therefore effective.

In addition to editorial changes, the corrigendum essentially affects class I products, which are highly classified by the MDR (i.e. software as a medical device and reusable surgical instruments of class Ir):

By way of derogation from Article 5 of this Regulation, a product which is a Class I product according to Directive 93/42/EEC, for which an EU declaration of conformity has been drawn up before 26 May 2020 and for which the conformity assessment procedure according to this Regulation requires the involvement of a notified body or for which a certificate according to Directive 90/385/EEC or Directive 93/42/EEC is valid according to paragraph 2 of this Article may be placed on the market or put into service until 26 May 2024, provided that it continues to comply with one of those Directives after 26 May 2020 and ...".

Attention: The longer transition period only applies to products for which a declaration of conformity has already been issued before 26.05.2020 and not to "newer" products!

The enormous pressure for manufacturers whose products are upgraded to classes IIa, IIb or even III under the MDR could thus be dropped for the time being. If you are one of these manufacturers, I would nevertheless advise you not to delay the search for a notified body for too long. Resources are scarce and it is not expected that this situation will change massively for the time being. Plan in good time (e.g. by means of certification to DIN EN ISO 13485 by us) so that 2024 does not see the situation that would have occurred almost in 2020.

Best regards,

Your team at Berlin Cert

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