Date of Application

Date of Application of the Medical Device Regulation is finally here. 

What you need to know: factsheet for manufacturers of  medical devices. 

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. 

Medical Device CROs Market

According to the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), at present, there are close to 175,000 types of medical devices available in the US.

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

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