2 thoughts on “Corrigendum for the EU MDR Published”

  1. Hi Marcelo,

    Regarding item #7 excluding animal-derived devices from the soft transition. Would these devices still not be in scope of Article 120(4) and thus still be available for sale through 2024 (or until their MDD cert expires)?

    Thanks!

    1. Hi, Tina,

      I don’t have the time right now to carefully review this topic, but from what I remember, devices under 120(10) are already not into the scope of 120(4), because 120(4) talks about devices copying the the directives 90/385/EEC or 93/42/EEC, and 120(10) talks about devices copying “with the rules in force in the Member States”. From what I remember reviewing this in the past, it seemed that 120(10) was applied to devices which were not under the scope of the directives (but were, for example under the scope of Directive 2004/23/EC in the case of g) , but were now under the scope of the MDR, so they are two different things (also, devices under 120(10) can still be in the market following the specific rules of the member states, even if those are beyond 27 May 2025.

      The corrigendum is only correcting the error that devices under f) were already into the scope of the directives 90/385/EEC or 93/42/EEC, and thus 120(4) is applicable to them, not 120(10).

      So, regarding your question, those devices under 1 (6) f are right now clearly under 120(4) as they should have been.

Leave a Reply

Your email address will not be published. Required fields are marked *