The Medical Devices Regulation (MDR) 2017/745’s Article 120.3 is applicable to legacy devices, and the European Commission has proposed a new proposal to extend the certification period for those devices. This suggestion follows the EPSCO meeting talks on the time period extension for older devices that were discussed in an earlier post. Pls click here to read the earlier post. In light of this, the following can be listed as some of the proposal’s primary points:
Depending on the device’s risk and type, the transition period extends; hence medical devices covered by a certification or/and statement of compliance issued before May 26, 2021, will have the following periods:
- Higher risk devices ( Class III devices and Class IIb implantable devices) until 31st december2027.
- Medium and lower risk devices (some of the Class IIa devices Class I devices placed on the market in sterile condition or having a measuring function, Class I devices that will need to involve a notified body for the MDR conformity assessment) until 31st december2028.
The conditions for the extensions:
- There isn’t an unacceptable risk to the patients’ safety or health from the devices;
- Changes should not be done in design and intended purpose of the devices
- Manufacturer has set up an MDR complaint QMS by 26 May 2024 (Article 10.9 MDR);
- Manufacturer complies with both the MDD and the MDR’s legacy requirements;
- The Manufacturer or his AR (Authorized Representative) has requested a conformity assessment from a notified body under the MDR, by the latest 26May 2024.
- Manufacturer and notified body have signed a written agreement – by the latest 26 September 2024.
Additional key points to remember:
- The transition period for Class III implantable custom-made devices will be until 26May 2026, if manufacturer apply for conformity assessment before 26May2026
- Depending on the risk class above, the extension of the transition periods also means an extension of the validity dates of certificates issued up until May 26, 2021, to December 31, 2027 or 2028;
- The main aim of this proposal is “removal of the sell- off provision set in the MDR and IVDR, that was originally envisaged to require manufacturers to withdraw non-Regulation complaint devices at a specific date.
To ensure the supply of medical devices to the EU market and to mitigate the risk of shortages, this extension is necessary. Important thing to note down here is that this is a proposal from the European Commission and that it must be approved by both the European Parliament and the Council of the European Union in order to be implemented as part of the legislative process for the EU.
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