Retaining the legacy status of a medical device is essential for manufacturers who have not yet reached full compliance with the Medical Devices Regulation (MDR). Article 120 of MDR provides deadlines a manufacturer must be aware of, so to fulfil the various obligations the Regulation imposes to keep placing MDD compliant devices on the EU market.
The next up-coming deadline for the manufacturers of legacy devices is on 26 September 2024.
September 2024 deadline for legacy devices
According to article 120, no later than 26 September 2024, manufacturers must have signed a written agreement with a notified body for the MDR CE Certification of their legacy devices. By 26 May 2024, manufacturers had to file an application with the notified body, which should be officialised with this written agreement.
Compliance with these deadlines do not, on its own, ensure the continuation of the legacy status of a device. The obligation this deadline poses is cumulative to the rest of the legacy requirements that the Regulation sets.
Overview of legacy deadlines
The main requirements for manufacturers of legacy devices are:
- Submission of an MDR application within 26 May 2024
- Quality management system (QMS) in place within 26 May 2024
- made Devices continue to comply with the applicable Directive;
- No significant changes in the device’s design and intended purpose
- Devices continue not to present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
- Compliance with MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices
Market surveillance from September 2024
At the latest by 26 September 2024, the signed agreement also specifies that the notified body responsible for the appropriate surveillance is the notified body designated for the MDR certification. After that date, the notified body that issued the Directive’s certificate can no longer perform surveillance activities. Nonetheless, the “outgoing” notified body should cooperate with the MDR notified body to enable a smooth transfer of the surveillance activities.
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