3EC  International is designated

Slovakia's 3EC International became  designated under the Medical Devices Regulation (MDR) and the 16th overall with less than a year before the regulation’s new date of application.

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September 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.

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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

MDCG 2020-14

MDCG 2019-10 rev 1 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC has just published.

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August 2020

MDCG 2019-10 rev 1

MDCG 2019-10 rev 1 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC has just published.

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August 2020

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