We are happy to share with you that the consolidated version of the MDR – Regulation (EU) 2017/745 was published on EUR-lex.
The new text covers both Corrigendums to the MDR, first (May 2019) and second (December 2019), which is of significant importance for the manufacturers of Class I devices that will be up-classified under the MDR as well as for Class I reusable surgical instruments that will need a Notified Body under the MDR. This topic was previously discussed on our blog.
We would also like to inform you that our Library of documents – LAW icon is continuously updated with the MDR national implementing legislation, which will allow you to be aware of national requirements when marketing your devices in different EU Member States after 26 May 2020.
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