After months of negotiations, the United Kingdom (UK) and the European Union (EU) finally reached an agreement that will define their future relationship, which came into effect at 23:00 GMT on December 31, 2020. As of this date, the UK is a “third country” from the EU perspective, and the same applies to the European Economic Area (EEA)from the UK perspective.
This context has been one of great change for all businesses, in which medical devices have not been the exception. From that date, for medical devices to move between UK and EEA markets, new requirements must be met. But this not only affects England, it also affects Northern Ireland in a special way, where its situation also becomes “special”
Up to this point, Switzerland have been able to feel part of the EU for the Medical Devices industry. However, from the Date of Application of the EU Medical Devices Regulation (MDR) on May 26, 2021, this is no longer the case and Switzerland will become a “third country” as regards medical devices, such as UK.
The Massachusetts Medical Device Development Center (M2D2) is a lifeline for the state’s smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and the UMass Medical School campuses of the University of Massachusetts. See our M2D2 Sponsors.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on registration requirements and deadlines for medical devices and IVDs effective January 1, 2021 for some products.
Why RQMIS is your Best Option? No hidden fees! Our procedures comply with EU REGULATION (EU) 2017/745 for AR companies. Our prices are competitive with other ARs, BUT our basic price structure includes ALL of the required responsibilities of an AR.