The European Commission has published a series of documents to support manufacturers’ post-market surveillance and vigilance reporting.
Three of the first four product categories on which it has chosen to focus are in the high-risk area of...
EU Creates Manufacturer Vigilance Template And Cardio And Breast Implant Reporting Tables
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Reports by manufacturers to authorities of serious incidents related to breast implants and some cardio products can now be standardized.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
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