Crunch Time: Will EU Allow Article 97 Solution To MDR Bottlenecks Or Will MDR Be Delayed?
Do all roads lead back to the reopening of the Medical Device Regulation and risk-based staggered delays as was introduced with the IVD Regulation? Medtech Insight spoke to TÜV SÜD’s Dr Royth von Hahn and BSI’s Graeme Tunbridge, about how potential solutions to MDR delays are being received.
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With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.
The ongoing availability of many medical devices in Switzerland is threatened even more severely than in the EU. Medtech Insight spoke to two key life science experts to understand why this is and to hear the solutions they are proposing.
There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.