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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.