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Implementation of Medical Devices EU-Regulation

MediMark Europe has made a selection of documents which may help you to understand and comply with the MDR (EU) 2017/745 which will apply from 26 May 2020. Some provisions of the MDR will come into force earlier (e.g.regarding Notified Bodies and the Medical Device CoordinationGroup). Some will apply later (e.g. regarding UDI labelling).

So, you will find below:

- A document which summarizes the necessary Technical Documentation for Compliance with the EU Medical Device Regulation 2017/745;

- A table which focus on Manufacturers’ obligations (MHRA);

- A "Step by Step Guide" and a "Factsheet for Manufacturers of MD" published by the European Commission.

Our customers will find additional documents in the section "members" - Private News.

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