About this initiative

Topic
Business and industry, Single market
Type of act
Implementing regulation
Committee

Draft act

Feedback: closed
Type

Draft implementing regulation
More about draft acts

Feedback period
27 September 2017 - 25 October 2017
View feedback received >
Download (228 KB - PDF - 3 pages)
Download (292.6 KB - PDF - 11 pages)

Feedback (13)

  • TÜV SÜD Product Service GmbH (Notified Body ID 0123) (Germany)
    25 October 2017 Company/business organisation
    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)
    25 October 2017 Business association
    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.

  • ISS (Italy)
    24 October 2017 Academic/research institution
    ISS (Italy)

    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...

All feedback (13) >

Commission adoption

Type

Implementing regulation
More about adopted acts

Download (94.5 KB - PDF - 4 pages)
Download (195.2 KB - PDF - 11 pages)

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