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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 extension of the validity of certificates is subject to certain conditions. Specifically:
Devices certified under the MDD, may be placed on the market or put into service until the following dates:
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.
Devices placed on the market before or during the transition period will be available on the market without time a deadline.
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.
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 firstname.lastname@example.org | (+39) 393 2471040