The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part of Article 110.3 IVDR. The guidance is also relevant for manufacturers of IVD legacy devices to be aware of the expectations when it comes to the verification of their documentation by a notified body in the transitional period.
Firstly, the MDCG indicates that the notified bodies shall continue surveillance activities under the IVDD. Additionally, they need to take into account the new requirements, which are namely the following:
- Contractual relation: contracts between the notified body and manufacturer should cover surveillance activities to be performed by the notified body during the whole transition period. This must include the right to suspend, restrict or withdraw existing certificates.
- Review of Quality Management System documentation: the notified bodies need to verify the scope of the devices covered by the IVDD Certificates; the adjustment of the QMS by the manufacturer related to significant changes as per Article 110.3 IVDR; the inclusion of risk management and performance data into the post-market surveillance plan, etc.
- Audit activities: the notified bodies should perform surveillance audits, especially focusing on manufacturers’ PMS plans and reports.
- Information to the Competent Authorities: in cases of unacceptable risk to the health or safety of the patients following an audit.
Furthermore, the guidance also states cases of individual audits to be carried out by the notified bodies, such as on-site audits concerning four different scenarios for manufacturers of “legacy devices”, and lists the characteristics of every audit under each case.
This MDCG guidance goes in line with previously issued guidances such as the MDCG guidance on appropriate surveillance under MDR and the MDCG guidance on application of IVDR requirements to legacy devices.