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GMP News

12.01.2026

MDCG publishes Guidance on the Surveillance of Medical Devices and IVDs

At the end of 2025, the Medical Device Coordination Group (MDCG) published the guideline 'MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices'. What does it contain?

12.01.2026

Real-world Evidence Data now also expanded in the Field of Medical Devices

Real-world evidence (RWE) is an approach that has gained importance in both the EU and the US in recent years. Real-world evidence helps when clinical trials cannot take into account the entire patient population with a particular disease. This concept is now to be expanded to include medical devices in the US. What is planned?

12.01.2026

Could a change of ownership be relevant to GMP?

The subject line asks whether a change in the ownership of a pharmaceutical manufacturer could affect GMP compliance. According to the FDA, the answer is yes.

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