top of page
  • Writer's pictureARQon

EU MDR - Timeline Updates by European Commission


Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

On 12 April, the European Commission published an infographic (see above) that describes the transition from MDD to MDR, as a guideline for manufacturers to plan their transition.

For more information, check out this link: https://ec.europa.eu/docsroom/documents/34907?locale=en

MDR and IVDR - Implementing Measures Rolling Plan

On 15 April, the European Commission published a rolling plan that contains the list of identified essential implementing acts, actions and guidance to be put in place by the Commission and/or the MDCG during the transitional period together with relevant information on expected timelines and state-of-play. The information is organised into two main sections (implementing acts; other actions/initiatives).

The document will be subject to quarterly review in order to provide the authorities and stakeholders with the most updated information.

For more information, check out this link: https://ec.europa.eu/docsroom/documents/34941

Medical device manufacturers will have to comply with the MDR by May 2020. It is important to start the transition as soon as possible. The Regulation allows for transitional provisions if more time is needed due to the

  • high number of devices on the market

  • anticipated bottleneck in reviews by notified bodies

  • ongoing need to interpret certain provisions of the Regulations

An early start is especially important because of the expected pressure on notified bodies during the transition period. Approach your chosen NBs as soon as possible. Check whether they intend to apply for designation under the new Regulation, including the scope they intend to cover, and when they think they will be ready.

Contact us at info@arqon.com.


862 views0 comments

Recent Posts

See All

Europe - May 2020

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by one year EU: Continued use of lead as a thermal stabiliser in P

EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

EU 2020 MDR Guidance Notes For Class I Manufacturers

There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the conformity for Class I medical devices which are not subject to up-cla

bottom of page