Products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on medical devices.

Draft Commission Implementing Regulation amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council; (5 page(s), in English)

The draft measure amends the transitional provisions established in Commission Implementing Regulation (EU) 2022/2346 (notified under G/TBT/N/EU/866). All the periods are extended and for Annex XVI products covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC, the conditions to benefit from the amended transitional provisions are aligned to those established by Regulation (EU) 2017/745, as amended by Regulation (EU) 2023/607 (notified under G/TBT/N/EU/943).