EU Parliament

Annex XVI Product: Official Q&A Released

Regulation (EU) on Medical Devices (MDR) now includes products without a specific medical purpose listed in its Annex XVI. Common specifications for risk management of these products have been outlined in Commission Implementing Regulation (EU) 2022/2346 (CS), effective from June 22, 2023. Regulation (EU) 2023/607 extended transitional provisions under MDR from March 20, 2023, introducing …

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