The Good And Bad News When It Comes To EU Notified Bodies’ Designation Capacity
Executive Summary
The entire medtech sector is all too aware of the lack of capacity among notified bodies to support the EU medical device and IVD regulations. But what really matters is how much notified body capacity there is in a given product area as this will have the most influence on conformity assessment timelines for individual products.
You may also be interested in...
Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie
MedTech Europe says solutions are still urgently needed to ensure the MDR is on course and warns that 50% of companies are deprioritizing the EU as launch market, potentially denying EU citizens vital health care.
European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products
The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.
Why EU Regulations Are Changing The Face Of Innovation And May Be Unsustainable
The EU must keep its medtech regulation under review as rapidly changing technology and external market factors may be challenging the operability of some aspects of the new medtech regulations, especially for less mature businesses and SMEs. Legal medtech expert, Shuna Mason, of CMS explains why.