On 28 March 2023, the European Commission published in the Official Journal of the European Union the guideline Questions&Answers (Q&A) entitled “Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain Medical Devices and in vitro diagnostic Medical Devicesche” to clarify certain aspects contained in Regulation 2023/607.
The document aims to answer the most frequently asked questions by medical device manufacturers regarding the third extension period formalised on 20 March and aims to facilitate the application of Regulation 2023/607.
Here are some particularly significant aspects.
- For implantable class III and IIb devices with a deadline of 31 December 2027 and class IIa and I devices with a deadline of 31 December 2028, it is clarified that the extension takes place automatically by law, provided that the devices do not present unacceptable health and safety risks and have not undergone significant changes in design or intended use.
- MDD and AIMDD certified devices can benefit from the extension if the device certificates have not been withdrawn by Notified Bodies.
- Certificates that expired before 20 March 2023 are valid in the following cases:
– if before the deadline the Manufacturer and a Notified Body have signed a contract for the conformity assessment of the device;
– if a Competent Authority has granted a derogation pursuant to Article 59 MDR (EU) 2017/745;
– if a Competent Authority has requested the Manufacturer to perform the conformity assessment procedure pursuant to Article 97.
- Custom-made legacy devices (including implantable devices) may be placed on the market until 26 May 2026, provided that the Manufacturer has submitted an application for conformity assessment to a Notified Body by 26 May 2024 and the relevant contract has been signed by 26 September 2024.
- Manufacturers must draw up documentation on their quality management system in accordance with MDR (EU) 2017/745, to be included in the application for conformity assessment to be submitted by 26 May 2024.
- The tripartite agreement (Art. 58 MDR (EU) 2017/745) concluded between the Manufacturer, the outgoing Notified Body and the incoming Notified Body must provide for the transfer of the relevant documentation from the outgoing Notified Body to the incoming Notified Body and the latter may suspend or withdraw a certificate issued under MDD or AIMDD. In addition, the incoming Notified Body is not responsible for the conformity assessment activities carried out by the outgoing NoBo and is not responsible for adequate surveillance of the device on the market, unless otherwise agreed between the Manufacturer and the incoming NoBo by 26 September 2024.
- In the case of a transfer of responsibility for surveillance, pre-existing devices may continue to be made available without changing the labelling, including the CE marking and the number of the Notified Body that issued the certificate. However, the manufacturer may request to change the labelling and indicate the number of the incoming Notified Body.
- For both Medical Devices and In Vitro Diagnostic Medical Devices, the sell-off period is cancelled, i.e. the end date for the further making available of devices already placed on the market before or during the end of the transition period. Devices placed on the market before and after 26 May 2021 can therefore continue to circulate without any time limitation.
>> Through its strategic-regulatory consulting services, CE certification support and, if necessary, European authorised representative, Thema can help you implement the requirements of Regulation 2023/607 to benefit from the extension and the MDR (EU) 2017/745 Medical Device Regulation.
Contact us for information.
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