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 Regulation 2023/607. The flowchart should help to determine the eligibility, conditions and deadlines for the placing on the market or putting into service of certain devices in accordance with Article 120 MDR. The user of the flowchart is advised to consult the text of the MDR, which takes precedence over the flowchart, and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.
The flowchart is divided into two parts:
Part 1: ‘Legacy devices’ referred to in Article 120(3a) MDR, i.e. devices covered by a certificate issued by a notified body in accordance with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) prior to 26 May 2021; and ‘legacy devices’ referred to in Article 120(3b) MDR, i.e. devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC (MDD) did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to the MDR requires the involvement of a notified body.
Part 2: Class III custom-made implantable devices referred to in Article 120(3f) MDR).
What does this mean to you?
This flowchart is relevant for all MD manufacturers for placing ‘legacy devices’ and class III custom-made implantable devices on the market or putting them into service in accordance with Article 120 MDR, as amended by Regulation 2023/607.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
