Get Ready EU MDR: Factsheet & Step By Step Guide for Manufacturers of Medical Devices, FAQ

June 28, 2019

 

 

Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).

The transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. To avoid market disruption and allow a smooth transition from the Directives to the Regulation, several transitional provisions are in place (Article 120). Some devices with certificates issued under the Directives (AIMDD/MDD certificates) may continue to be placed on the market until 27 May 2024 , and made available until 27 May 2025.)  

 

European Commission prepared the following EU MDR Factsheet, Step by Step Guide and FAQ:  

 

 

European Commission highlights information are also available:

  • Call for clinical and other experts to be published later in 2019

  • The Commission designates entities to operate a system for assignment of unique device identifiers (UDIs)

  • EUDAMED device data elements' registration timeline

  • EUDAMED legacy devices' registration

  • Interpretation of MDR article 54(2)b

  • Field safety notice template and supporting documents are online

  • Updated MDR and IVDR implementing measures rolling plan is online

  • Further guidance: regulation of medical devices if there’s no Brexit deal

  • Using the UKCA marking if the UK leaves the EU without a deal

ARQon EU MDR Book:

 

ARQon Medtech Europe GmbH, Mr Daniel Shoukier (also external DQS notified body auditor and TUV SUD Academy trainer) written the EU MDR book, sharing his view of each Articles in the EU MDR in simple Q&A format, digesting the detailed EU MDR regulation. The book was sold out during the Medtech Summit 2019 Brussel and those who are interested, you may also contact us for purchase at EUR60.

 

Source:

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations_en

 

 

Contact us at info@arqon.com.

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