EU Post-Market Surveillance: How Doing More Than Minimum Will Benefit Medtech Manufacturers
Post-market surveillance requirements apply to all products under the EU’s Medical Device Regulation. Companies would do well to evaluate the additional benefits PMS can offer them, leading devices expert Bassil Akra explained during a recent interview.
You may also be interested in...
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.
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.
In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.