Lobbying on Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices | OpenLobby.EU

Codes for the designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices

Business and industry, Single market

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Public consultation

ID: 1115

Lobbying Activity

4 responses

Consultation response

MedTech Europe, 25 Oct 2017

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…

Consultation response

Portia Ltd, 5 Oct 2017

It must be taken into consideration that the role of sexual dimorphism at cell and biochemical level is almost completely missing from the literature on in vitro diagnostics, e.g. Biotechnol J. 2014 Jan; 9(1): 16–27. Published online 2013 Dec 4. doi: 10.1002/biot.201300187 and Drug Discov Today.…

Consultation response

TÜV SÜD AG, 25 Oct 2017

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…

Consultation response

ISTITUTO SUPERIORE DI SANITA', 24 Oct 2017

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…