MDR Transitional Timeline Flow Chart.
The European Commission has published a Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period Medical Device Regulation (MDR) 2023/607. The flowchart 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.
Regulation 2023/607 has added transitional timelines to EU Medical Device Regulations where the new timeline applies to certain medical devices. All new registrants for Medical devices need to follow the original compliance requirements and comply with the EU Medical Device Regulation [MDR] and In-Vitro Diagnostic Regulation [IVDR], which came into action on 26 May 2021 and 26 May 2022, respectively.
This flowchart is for Medical Manufacturers who have
- ‘Legacy devices’ referred to in Article120(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.
- Class III custom-made implantable devices referred to in Article 120 (3f) MDR).
Are you wondering whether your medical devices fit into this requirement or not?
Contact our experts for complete support in understanding your device and relevant regulatory requirements.
Considering the Flow chart, Medical Device Manufacturers need to focus on
- Classification of Medical Devices
- Conformity Assessment
- Post-Market Surveillance
- Quality Management Systems [QMS]
Experts at Med-Di-Dia are already helping manufacturers by eliminating regulatory challenges by becoming a Regulatory Risk Partner for Medical Devices, Diagnostics and Digital Health!
Click here to access the Flow Chart on Conditions and deadlines 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