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Regulation (EU) 2023/607 of 15 March 2023 amends Regulations (EU) 2017/745 and (EU) 2017/746 regarding transitional provisions for certain medical devices and in vitro diagnostic medical devices. What are these amendments and what changes for companies?
THE CONTEXT
The overall capacity of notified bodies designated under Regulation (EU) 2017/745 is still insufficient to ensure the conformity assessment of the large number of devices certified under Directive 93/42/EEC by the end of the transition period (26 May 2024). In addition, a large number of manufacturers are not sufficiently prepared to certify compliance with the more complex MDR requirements.
Therefore, on 20 March 2023, the Regulation (EU) 2023/607 was published in the Official Journal of the European Union, urgently extending the validity of certificates issued in accordance with Directive 93/42/EEC and extending the transition period during which MDD-compliant devices can be lawfully placed on the market.
The extension aims to avoid shortages of necessary medical devices on the EU market by giving notified bodies enough time to carry out the required conformity assessments.
THE AMENDMENTS TO THE MDR
Extension of the validity of certificates issued under the MDD.
The extension of the validity of certificates is subject to certain conditions. Specifically:
- certificates issued by notified bodies in accordance with the MDD that were still valid as of 26 May 2021 remain valid after the term indicated on the certificate, until the dates indicated below, according to the risk class;
- MDD certificates that were still valid on 26 May 2021 but expired before 20 March 2023 remain valid only if one of the following conditions is met:
- before the expiration date of the certificate, the manufacturer has signed a written agreement with a notified body for MDR certification of the device,
- a competent authority of a Member State has granted a derogation or required the manufacturer to carry out the applicable conformity assessment procedure.
Staggered and conditional extension of the transition period.
Devices certified under the MDD, may be placed on the market or put into service until the following dates:
- 31 December 2027 for Class III and Class IIb implantable devices (with some exceptions);
- 31 December 2028 for Class IIb (not included in the previous point), Class IIa, and Class I devices (sterile or with measuring function);
- 31 December 2028 for Class I devices that did not require the involvement of the notified body, with declaration of conformity issued before 26/05/2021 and for which the involvement of the NB is required under the MDR;
- 26 May 2026 for class III custom-made implantable devices.
One of the necessary conditions for placing such devices on the market is that by 26/05/2024 the manufacturer has submitted a formal application to a notified body and by 26/09/2024 a written agreement has been concluded between the parties.
Elimination of “sell-off” date.
Devices placed on the market before or during the transition period will be available on the market without time a deadline.
Surveillance by notified bodies.
Devices covered by an MDD certificate remain under appropriate surveillance by the body that issued the certificate. Alternatively, the manufacturer may agree with a notified body designated under the MDR that the latter shall carry out such surveillance. By 26/09/2024, the MDR body that signed the written agreement with the manufacturer becomes responsible for appropriate surveillance.
ECM NOTIFIED BODY 1282
Considering the complexity of the MDR certification procedure, which involves longer assessment times than in previous directives, we encourage manufacturers to contact our Notified Body 1282 as soon as possible to start the process for certification of their device under Regulation (EU) 2017/745.
For more information, please feel free to contact our Sales Manager Diego Stevanella at diego.s@entecerma.it | (+39) 393 2471040
