28.08.2023
To the attention of manufacturers, authorised representatives, economic operators and all interested parties
We inform you that on 23 August 2023, the European Commission published the diagram with the conditions and deadlines for placing on the market or putting into service of “legacy” devices and custom-made implantable class III devices, in line with Article 120 of the MDR, as amended by Regulation 2023/607.
The flowchart is intended to help manufacturers and other relevant actors decide whether the device is covered by the extended transition period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by Regulation 2023/607.
The flowchart should determine the eligibility, conditions and deadlines for placing on the market or putting into service of certain devices, in accordance with Article 120 of the MDR.
It is also recommended to consult the text of the MDR, which takes precedence over the diagram, and the questions and answers on practical aspects related to the implementation of Regulation (EU) 2023/607.
The flowchart is split into two parts:
Part 1: Legacy devices referred to in Article 120(3a) of the MDR, i.e. devices covered by a certificate issued by a notified body, in line with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) before 26 May 2021 and legacy devices referred to in Article 120(3b) of the MDR, i.e. devices for which the conformity assessment procedure, in accordance with Directive 93/42/EEC (MDD), did not require the involvement of a notified body, for which the declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure in accordance with the MDR requires the involvement of a notified body.
Part 2: Class III custom-made implantable devices referred to in Article 120(3f) of the MDR.
The notification can be downloaded from the European Commission website:
https://health.ec.europa.eu/latest-updates/flowchart-assist-deciding-whether-or-not-device-covered-extended-mdr-transitional-period-2023-08-23_en
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