Manufacturers Of Annex XVI Non-Clinical Devices Get Extra Time

Following the timelines laid out in the European Commission’s new implementing regulation for Annex XVI non-clinical devices is not for the faint-hearted. It involves multiple cross-referencing between several commission regulations. Medtech Insight clarifies the situation.

Anti-aging aesthetic medical treatment. 3d illustration of plastic surgery.Mesh and lines in the skin and procedure to eliminate wrinkles

Manufacturers of products without an intended medical purpose that fall under the EU’s Medical Device Regulation (MDR) and are listed in its Annex XVI are going to have longer to comply with the requirements of that text.

The periods are being extended between 18 and 30 months for products that are subject to clinical investigations, and as...

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