Regulatory News
Picked worldwide
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.
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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.
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March 2019
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.
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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.
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April 2020