The French testing and certification body, GMed, has been designated under the EU’s new Medical Device Regulation, making it the 15th MDR notified body in the EU. It offers a near full range of MDR testing services, including a full range in the area of active implantables.
GMed Designated As France’s First MDR Notified Body
The designation of France’s GMed as an EU notified body will be a huge relief to the French medtech industry. Some 30% of the country's medtech sector, the second largest in Europe, uses its services.
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
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Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
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Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
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Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.