All medical devices to be placed on the EU market must have a CE mark. Thus, a medical device must meet requirements of the EU ruling documents. The Directives 90/385/EEC and 93/42/EEC were used previously. However, EU MDR was established in 2017 and preliminary should be adopted by May 26, 2020.
If certificates were issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC up to 2020, they remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void not later than May 27, 2024.
The EU MDR contains significant changes in approach to the medical device approval. These changes have an impact on the whole CE-marking procedure.
Even though it was given a three-year transition period to enable manufacturers to prepare for this MDR, there are still a lot of nuances for new medical devices to be marketed in the EU.
In light of this and with relation to the current situation in the world resulting from the coronavirus crisis, the EU Commission is working on a proposal to postpone the date of the EU MDR application.
Most probable that implementation of the MDR will be postponed for one year.
GMA Consult Group will keep you up to date on the news regarding the implementation of the EU Medical Device Regulation.
Please, find the announcement from the EU Commision here.
The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side. Need your own guide to the world of certification and approvals? Don't hesitate to contact us via firstname.lastname@example.org.