The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance duties as per Article 120.3 of the Medical Devices Regulation 2017/745. These also relate to legacy device manufacturers’ requirements on their quality management systems.
- Identify which existing MDD or AIMDD certificates will continue to be used and if their scopes remain unchanged;
- Ensure that previous rights and duties under the Directives will continue being applicable: This is done through the signing of a contract between the manufacturer and the notified body that includes surveillance activities on legacy devices during the transition period (until 26 of May 2024 or the ending date of validity of the CE Certificate, whatever it comes sooner);
Moreover, regarding the quality management system (QMS) of the manufacturer, the notified body needs to verify several aspects. These are summarized in the following points:
- Scope of devices covered by MDD/AIMDD Certificates;
- Whether the manufacturer has adapted its QMS to the requirements in Article 120.3. MDR and taking into account the following guidance;
- Whether the manufacturer has incorporated MDR requirements into its post-market surveillance, market surveillance, vigilance and registration of economic operators and devices. This has a special focus on feeding processes related to post-market surveillance into the post-market surveillance plan and an appropriately updated PSUR. Periodic safety update reports (PSURs) need to be drawn up as per Article 86 MDR one year after the date of application of the MDR, i.e. following 26 May 2021.
Adding to this, notified bodies also need to carry out audit activities until the end of the transition period or the end of the validity of the certificates under MDD/AIMDD. This is intended to be a continuation of the previous surveillance activities but focusing on the new MDR provisions. During the carrying out of these activities, manufacturers shall make available PSURs, PMS plans and reports to their notified bodies, for the verification of the continued compliance of the devices involved in the above-mentioned certificates.
Should a major non-conformity be found during the audit or the certificates be suspended, re-instated, restricted or cancelled, the notified body must inform the relevant competent authority as per Article 122 MDR.
Moreover, the surveillance activities may vary depending on the following situations, the legacy device manufacturer:
- has not applied for certification under MDR;
- has already implemented MDR requirements in its systems and is currently applying for MDR notification by the same notified body that issued its MDD/AIMDD certificates;
- is already certified by the same notified body under MDR for the same and/or different type of devices;
- is already certified under MDR by a different notified body;
Thus, the notified body should describe each of the different scenarios of the manufacturer and implement the appropriate audit programs, audit plans and a demonstration of similarities claimed. Finally, the guidance provides a comparison table between MDD/AIMDD quality management system requirements and MDR requirements for the use of notified bodies, especially for the situations 2) to 4) above.
You can find the full text of the MDCG Guidance in our dedicated Library – Notified Body.