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Draft Reg extends Annex XVI CS implementation time to align with new MDR transition times

  • Posted by: inetika
  • Category: GLOBAL NEWS

A new Commission Implementing Regulation will soon be published to align the implementation timescale for the Common Specification (CS) on MDR Annex XVI products with the revised transition timescales for legacy devices covered in Regulation (EU) 2023/706.

The full title of the new regulation as currently drafted is: “Regulation amending Commission Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745.”

The Commission explains: “Regulation (EU) 2023/607 of the European Parliament and of the Council amended Article 120 of Regulation (EU) 2017/745 (MDR) extending the transitional periods and setting several conditions to be met for benefitting from those new transitional periods.

Specific conditions and transitional periods for certain products are also established by Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for Annex XVI products (CS). To ensure alignment between the MDR and the CS, the transitional periods and the related conditions from the CS need to be reconsidered.”

Continuing: “To address those needs, a draft implementing measure amending the CS transitional provisions has been prepared and discussed with the members of the Annex XVI Task Force.”