MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD – published at cemarking.net – May 2, 2022
One of the tasks of each notified body is to continuously monitor the functionality of certified medical devices. The Medical Device Coordination Group (MDCG) has published policy rules for this purpose. It concerns devices with certificates issued under two old directives: the AIMDD and/or the MDD.
Article 120 – Transitional Arrangements Under the MDR
On March 26, 2021, the new regulations for medical devices in the EU entered into force. The transition of products from the old directives is regulated in Article 120 of the MDR. This states, among other things, that devices with a valid certificate under the old directives may be placed on the market until May 26, 2024. Unless their design or intended purpose is substantially changed.
Policy Framework Drawn Up by the MDCG
The communiqué focuses on the appropriate surveillance requirements by notified bodies under Article 120(3) of the MDR. Only devices for which a valid certificate has been issued under the AIMDD or the MDD earlier than 26 May 2021 are covered.
What Must the Notified Body Do?
First of all, the notified body establishes after examination which certificates under the old directives will continue to be used. This includes an inspection of the (future) area of application. Furthermore, rights and obligations under the old directives must be maintained. This is laid down in a contract. It is essential that this covers the monitoring activities until the end of the transition period (May 26, 2024).
The Manufacturer’s Transition Plan for Compliance with the MDR
The manufacturer has created a transition plan for compliance with the MDR. A notified body also assesses the scope of devices covered by the old directives. In doing so, it will need to take into account the manufacturer’s transition plan. This includes whether the manufacturer has adapted its quality management system in accordance with the requirements of Article 120(3) (Section 4.3 of the Directives).
The Audit Program
The notified body has the right to adapt the audit program. This is possible as a result of the evaluation of all documentation and this shows that it is necessary. Indeed, unannounced audits are also a possibility if there is reason to do so. Previously, not all MDR provisions applied to older devices. For that reason, the audit activities of the notified bodies should be a continuation of the previous monitoring activities. However, this is also with attention to the additional MDR provisions.
In Case of Lack of Conformity
An audit may identify a serious lack of compliance with the regulations. If this poses an unacceptable risk to the health and safety of patients or other persons, intervention is required. In this case, a notified body must inform the relevant competent authority. In the event that a certificate is suspended, withdrawn, restricted or canceled, the manufacturer’s notification requirements must be met, under Article 122 of the MDR.
Tool MDCG for Notified Bodies Performing Individual Audits
The requirements drawn up in the MDR’s guidelines have been defined by the MDCG in this table:
This table is a tool for notified bodies performing individual audits. In addition to this table, the other, relevant, guidelines should also be used. In the case of Class IIa and IIb devices, Notified Bodies are requested to continue to apply the sampling plan established under the Medical Devices Directive to assess the technical documentation on a representative basis.
The guidelines also describe the possible scenarios that may arise if the technical records are assessed on a sampling basis.
MDCG Publishes MDR Surveillance Guidelines; Sources, Links and Downloads
Sources:
- MDCG 2022-4
- MDCG 2022-5
- Charleen O’Keeffe, Aisling Casey and Sinéad Cullen from William Fry.com on Lexology
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