There is more demand for notified body services than supply in the context of the EU’s Medical Device Regulation, so anything that can be done to make assessments go more smoothly and quickly will be in the interest of industry, notified bodies and patients. This is especially so as the bottlenecks grow towards the 26 May 2024 deadline for legacy products to demonstrate compliance with the MDR.
The EU’s medical device notified body association, TEAM-NB, has published a position paper which, among other things, lists what is needed in a technical documentation submission, and suggests a...