The Medical Device Coordination Group (MDCG) has published guidance on the activities to be performed by notified bodies as part of their ongoing surveillance role mandated under the Medical Device Regulation (MDR) in relation to certificates issued under the Active Implantable Medical Devices Directive or the Medical Devices Directive (the old directives).
Article 120 – Transitional arrangements under the MDR
The transition of products from the old directives to the new regulatory system for medical devices in the EU, which came into effect on 26 March 2021, is set out under Article 120 of the MDR. Under Article 120(3), devices covered by a valid certificate under the old directives (issued after 25 May 2017) may be placed on the market or put into service until 26 May 2024, where there are no significant changes to their design or intended purpose.
Guidance issued by the MDCG
The MDCG's recently published guidance (available here) covers the appropriate surveillance requirements by notified bodies under Article 120(3) of the MDR (Guidance). Only devices covered by a valid certificate issued under the Active Implantable Medical Devices Directive (AIMDD) or the Medical Devices Directive (MDD) before 26 May 2021 are addressed.
The notified body will need to identify and determine which certificates under the old directives will continue to be used, and whether there will be any change to their scope. It must ensure, on a contractual basis, that its rights and duties under the old directives will remain in place. It is essential that this covers surveillance activities until the end of the transition period (26 May 2024).
When considering the scope of the devices covered by the old directives, the notified body should consider the manufacturer's transition plan for MDR compliance, including whether the manufacturer has adjusted its quality management system according to the requirements of Article 120 (3) (section 4.3 of the Guidance).
Depending on the results of the documentation review, the notified body may adjust the audit programme to include various audit activities, even, if necessary, unannounced audits. As not all the MDR provisions previously applied to legacy devices, the audit activities of the notified bodies should be a continuation of the previous surveillance activities with an extra focus on the additional MDR provisions.
Notified bodies must inform the relevant competent authority should an audit activity reveal a major non-conformity that presents an unacceptable risk to the health and safety of patients or other persons. There must be compliance with the notification requirements of the manufacturer under Article 122 of the MDR, in the event of a certificate under the directives being "suspended, re-instated, restricted, cancelled". The MDCG has provided a comparison table setting out the requirements in the Directives, which the MDR also covers. This will assist notified bodies carrying out individual audits and should be used alongside the other guidance. In case of class IIa and IIb devices, notified bodies are requested to continue applying the sampling plan established under the MDD to assess the technical documentation on a representative basis. The Guidance also sets out the possible scenarios that may apply if technical file assessment is carried out on a sampling basis.