2021 witnessed a landmark event in May when the new Medical Device Regulation first applied. The medtech sector will experience a similar milestone this year with the new IVD Regulation coming into force in some four months' time. Medtech Insight reflects on the broad and complex swathe of changes that took place in 2021, putting industry under considerable pressure, and predicts no let-up this year.
During 2021, a great many updates occurred in parallel to support implementation of the new MDR and IVDR. This against an ever-shifting political backdrop and a time of health policy change.
The top 20 most read regulatory pieces in Medtech Insight in 2021 show a particularly interesting picture. What is striking...