Regulatory News
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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.
MDCG 2020-13
MDCG 2020-13 Clinical evaluation assessment report template has just been published by the European Commission.
July 2020

MDR postponed
To prevent shortages or delays in getting key medical devices on the market, Parliament decided to postpone the application of the Medical Devices Regulation.
April 2020
GMED is designated
France’s GMED became designated under the Medical Devices Regulation (MDR) and the 15th overall with less than a year before the regulation’s new date of application.
July 2020
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.
March 2019