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.