AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents

BY COREY JASEPH, MS, RAC

With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

Europe enacted the medical device (MDR) and IVD regulations (IVDR) in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time for implementation.

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