About this initiative
COMMISSION IMPLEMENTING REGULATION (EU) …/... on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
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TÜV SÜD Product Service GmbH (Notified Body ID 0123) (Germany)
Comments to the draft Implementing Act regarding IVDR codes The IVDR codes proposed in annex II of the draft implementing act create a 5 dimensional system consisting of design/purpose related codes (1st dimension) and 4 horizontal dimensions of codes to cover all types of IVD devices. In total 100 IVDR codes are defined. Beyond the pure number of codes the 5 dimensional approach creates a complexity which is hard to be handled adequately by...
MedTech Europe (Belgium)
MedTech Europe is pleased to submit comments for the draft Implementing Regulation which will set out codes for notified bodies in the field of medical devices (MD) and in vitro diagnostic medical devices (IVD). Our comments relate to both Annex I and Annex II. Please find our comments attached.
The proposal attached introduce changes to the draft of the implementation act that may facilitate the process of qualification of the of the Notified Bodies, with a minimal “word changing” in order to consent a rapid approval of implementation act possibly without any delay. We think that the goal of NBOG codes is the clear identification of the expertise needed to the NB in order to perform the evaluations; for this scope is necessary to...
Anonymous (United Kingdom)
The regulation does not include a procedure for how this list of codes may be updated. According to regulation 2017/745 Article 42(13) states this list may be updated, inter alia, on information between Notified Bodies, MDCG, and the Commission. However, there is no method to describe how this medical device code list gets updated with categories such as "MDA 0312: Other active non-implantable surgical devices." These "catch-all" categories...
Concerning Medical Devices: why not simply designate notified bodies according to the 22 rules defined in Annex VIII of the MDR? A NB would be designated for all MD falling into rule 1, 2, etc.... Addiing again another classification will only creat confusion.
LNE/G-MED (NB 0459) (France)
Modified attached file to the 1st comment.