Annex XVI Products Set To Have More Time To Comply With MDR

Devices without a clinical purpose that fall under the scope of the EU’s Medical Device Regulation need to be tightly regulated. Now it looks as though manufacturers will have more time to comply if they need it.

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The European Commission is proposing extending the deadlines by which the so-called Annex XVI products, devices without a medical purpose used in or on the body, need to comply with the EU’s Medical Device Regulation (MDR).

The latest draft document proposes amending Implementing Regulation 2022/2346, which lays down common specifications for these products.

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