The EU MDR Certification revised Regulations (EU) 2017/745 and (EU) 2017/746 on March 15, 2023, with respect to the transitional arrangements for certain medical devices and in vitro diagnostic medical devices. Under certain restrictions, the regulation establishes a staggered prolongation of the transition time outlined in Regulation (EU) 2017/745 on medical devices (MDR). Moreover, in EU MDR Certification, it eliminates the “sell-off” deadline under MDR and IVDR, which would have required devices that were put on the market before or during the transition periods but were still in the supply chain to be withdrawn.
Regulation (EU) 2023/607
The amended Regulation (EU) 2023/607 was officially published in the Official Journal of the European Union on March 20, 2023, and it took effect immediately after that.
The few amended Regulations are
- Regulations (EU) 2017/745 (3) and 2017/746 (4) of the European Parliament and of the Council establish a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. They set high standards of quality and safety for such devices and reinforce key elements of the previous regulatory framework, such as supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and introduce provisions ensuring transparency and traceability.
- Extends the period of validity for certifications granted under the Medical Devices Directives (MDD) that were still in effect on the day the MDR’s application deadline (May 26, 2021) and haven’t been revoked by a Notified Entity. Hence, Notified Bodies are not necessary to update the dates on the individual certificates because the extension is immediately relevant. The length of the prolonged transition time specified in the proposed Article 120(3a) through (3c) of the MDR corresponds to the term of the certificate’s validity extension.
- The following needs to be fulfilled in order for expired certifications to be extended when the proposed amendment becomes effective:
- A contract between the manufacturer and a Notified Body for the evaluation of the device’s conformance is in place as of the expiration date.
- As an alternative, a national competent authority may have authorized a derogation in line with MDR Article 59.
- Or have mandated that the manufacturer complete the conformity assessment process within a certain amount of time in compliance with MDR Article 97.
- The notification of devices benefiting from the transitional period should be transferred from the notified body that issued the certificate to a notified body designated under Regulation (EU) 2017/745 to ensure a progressive transition. The notified body should not be responsible for conformity assessment and surveillance activities.
- The extension should be limited to devices that are safe and have taken steps to comply with Regulation (EU) 2017/745.
- The European Parliament and Council delayed the date of application of Regulation (EU) 2017/745 due to the COVID-19 pandemic, but 26 May 2024 remained the end date of the transitional period. This is when some devices that comply with Directive 90/385/EEC or Directive 93/42/Eec can be legally put on the market or put into service.
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Source : Extension of the MDR transitional periods
