Top 20 EU Regulatory Stories Of 2020: Nightmare Year With Brexit, MDR Implementation … And COVID-19
Not only might each day feel like Groundhog Day now – with COVID-19 limiting everyone’s activities. But early 2021 puts the EU medtech sector in a similar place to early 2020. So what has changed?
You may also be interested in...
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.
Warnings gathered pace around a year ago that EU MDR implementation delays would see hundreds, even thousands, of products removed from market. MedTech Europe’s Oliver Bisazza explains how a disastrous situation was avoided but industry is still in choppy waters.