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On September 26th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on the transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR. The newly published Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing
On August 23rd, 2023, the European Commission released a flowchart which is intended to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by
On July 18th, 2023, the European Commission released an update Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Q&A on practical aspects related to
On June 30th, 2023, the Medical Device Coordination Group (MDCG) released Addendum 1 to the position paper MDCG 2022-18 on the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) to legacy devices for which the 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before
