Pivotal notified body text nears completion as screws ready to tighten
This article was originally published in RAJ Devices
A new code of conduct for European Union notified bodies should be finalised by the end of May1.
You may also be interested in...
A new European Directive threatens to disrupt enforcement of the MDR, due in force in May 2021, and could hamper market surveillance and potentially even fragment the single market.
In the EU, voices calling for a postponement of the IVD Regulation’s 2022 enforcement date are growing louder.
The designation of France’s GMed as an EU notified body will be a huge relief to the French medtech industry. Some 30% of the country's medtech sector, the second largest in Europe, uses its services.