Take Steps Now To Comply With IVDR Now Or Face The Consequences, Industry Told
Notified bodies are taking the carrot and the stick approach as they urge manufacturers to make their IVDR applications now, especially for class D IVDs, or risk being non-complaint when the deadlines have passed.
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There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.
EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.
There is a much-acknowledged urgency to ensure medtech products are certified as fast as possible, with fears persisting that delays will result in notified body bottlenecks and product shortages.