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Signing Contract

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After May 2020 studies can be performed only in one or more member states of the EU in order to be accepted by the NBs and CAs.

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Modern Building

MDCG 2019-6

The European Commission (EC) issued a Q&A document on Thursday to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

First Corrigenda

As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda.
 

Exemption Clarification

The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification of Article 54(2)b is “extremely urgent.”

Meeting

Plan for Eudamed

The European Commission (EC) issued long-awaited documents on two essential actions to implement the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR), namely the high-level functional specifications for Eudamed and its final assessment on the future nomenclature for the database. 

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