By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with a notified body for MDR CE certification. Before this deadline, manufacturers of legacy devices had to submit an application with a notified body by 26 May 2024. While meeting these deadlines is necessary, it alone is not sufficient for retaining legacy device status. This requirement is part of a broader set of obligations and deadlines under the Medical Devices Regulation (MDR).
Overview of legacy obligations and deadlines under MDR
Article 120 of the MDR sets out key provisions that manufacturers must follow to continue placing devices compliant with the previous Directives on the EU market. Overall, the main requirements for legacy devices include:
- Submission of an MDR application by 26 May 2024
- Implementation of a Quality Management System (QMS) by 26 May 2024
- Ensuring device complies with the applicable Directives (MDD or AIMDD)
- No significant changes to device’s design or intended purpose
- Ensuring device does not pose any unacceptable risks to health or safety
- Complying with MDR requirements for post-market surveillance, vigilance, and registration of operators and devices
Notified body’s surveillance from 26 September 2024
The Directive’s notified body continues to be responsible for the appropriate surveillance until 26 September 2024. However, if the manufacturer agreed with the MDR notified body that the latter becomes responsible for the surveillance before this date, the Directive’s notified body is not responsible for the appropriate surveillance. In both cases, the MDR notified body that signed the agreement will become responsible for the surveillance at the latest by 26 September 2024.
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