Europe medical device QA/RA blog

News and commentary on regulatory changes.

In Brief: New Blue Guide from European Regulators

The European Commission has published its latest “Blue Guide” covering all products subject to the European Union’s New Legislative Framework, including medical devices, IVDs and active implantable devices.

Emergo Group consultants in the US and Europe will be performing an extensive review of the new Blue Guide over the next several days, and will provide additional analysis of how medical device manufacturers will be impacted.

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