Reasons for Extension of the Transition Period
The MDR Regulation established high-quality standards and safety requirements for medical devices and in vitro diagnostic medical devices. In particular, there is a strong focus on notified body supervision, conformity assessment procedures, risk management, vigilance, market surveillance, clinical evidence requirements, PMS, PMCF, transparency and traceability.
The original date of application of the MDR was postponed to 26/5/2021 due to the pandemic and the end of the transition period was set for 26/5/2024. However, due to the lack of overall capacity of notified bodies in the EU and the resulting risk of a shortage of medical devices on the market and a public health crisis, the EU Regulation 2023/607 (Amendment to the MDR) was finally adopted, amending Article 120 of the MDR.
The Amendment was subsequently accompanied by an explanatory Questions and Answers document (Revision 1 in July 2023) which describes in more detail the various changes and the details of the use of the extended transition period.
Requirements for the Possibility of Using the Transitional Period
This Amendment brought an extension of the validity of all certificates issued under the MDD that were valid on 20/3/2023 (the date of adoption of this Regulation). This allows manufacturers to continue to place their medical devices on the market until the following dates
- 31/12/2027 for classes III and IIb implantable devices
- 31/12/2028 for classes I, IIa and the rest of IIb devices
but only if the following conditions are met:
- The medical devices continue to comply with the MDD
- No significant change can be made to the intended purpose or design of the medical devices
- Medical devices do not pose an unacceptable risk to the health or safety of patients or others
and further under the condition of performing the following actions within the specified dates:
- By 26/5/2024 the manufacturer shall implement a quality management system in accordance with MDR Article 10(9)
- By 26/5/2024 the manufacturer submits a formal application for conformity assessment to the notified body
- By 26/9/2024 the manufacturer shall sign a written agreement on conformity assessment with the notified body
In addition to the above, as of 26/5/2021 manufacturers must already comply with the provisions of the MDR regarding:
- Post-market surveillance
- Market surveillance
- Vigilance
- Registration of economic operators and devices
The surveillance of devices placed on the market under the MDD will be transferred to a new notified body with which the manufacturer has signed a written agreement from 26/9/2024 at the latest.
The Sell-Off Date Cancellation
Another innovation that the Amendment brought was the cancellation of the so-called sell-off date. According to the MDR, medical devices that were properly placed on the market according to the MDD could be supplied to the market no later than 27/5/2025. The Amendment abolished this term, thanks to which medical devices duly placed on the market can continue to be supplied to that market.