qmsWrapper has already written about the New EU Medical Device Regulation (MDR), and what you can expect when it comes into effect. Everyone is aware that all Medical Device companies that sell medical products in Europe must hold up to the new regulation. Companies that do not follow this regulation will not be allowed to sell their medical products in the European Union after May 26th, 2020. The impact can be severe.

However, according to the latest EC news, the MDR deadline may have been postponed. As a result of the disruptions caused by COVID-19. The European Commission is working on a proposal to postpone the MDR application date for one year.

If approved, the delay will come as a relief to the devise manufacturers. As a still significant change, the MDR delay may involve a co-decision procedure, meaning that the European Parliament and the Council would need to jointly adopt legislation mandating a new implementation date.

European Commission spokesman said they’ve been working on submitting this proposal for postponing the implementation and let the industry focus on urgent priorities related to coronavirus crisis.

Regardless of whether or/and when the delay will occur, medical device companies should always be on standby and as proactive as possible during this time. 

Medical device companies certainly need to move from MDD to MDR, they need to commit to GAP analysis, to check on existing QMS, with special reference to postmarket surveillance.

qmsWrapper suggests you to benefit from this slowdown to inspect critical points of your QMS in order to be ready once the situation returns to normal as before.

Take in consideration that 4 elements are having the biggest change within new EU MDR such as digital and physical labeling, postmarket surveillance, total life cycle traceability and increased requirements for clinical evaluation.

Do not hesitate to contact qmsWrapper or book a free Live Demo to remove all your doubts and be completely ready for the new deadline of MDR.

Comments (3)

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This statement isn't correct according to my interpretation: "Companies that do not follow this regulation (MDR) will not be allowed to sell their medical products in the European Union after May 26th, 2020."

Based on my understanding, until 25th May 2020, certification under Medical Device Directive (MDD) is possible and issued certificates will be valid for up to 4 years, before the MDR fully applies. So, until then, whoever has certificate issued according to MDD can sell its product on the market. In principle, a manufacturer can have both valid AIMDD/MDD and MDR certificates in parallel until the end of the transition period for certificates on 27 May 2024.

Hope some can clear this? What is the exact timeline for MDR transition?
I completely agree with you, John! The statement is not correct, but if it's going to be postponed, does it really matter? Because of this outbreak, all that will change probably, so very possible that even your statement will not be true soon.
Dear Andy, my statement won't be correct only in sense of the implementation dates. It will be postponed, yes. But, the companies certificated under the MDD will be able to sell their product even though the MDR certification starts.
The articles state they won't be. It isn't correct. Don't make confusion for readers!