- The European Commission's Medical Device Coordination Group (MDCG) has provided guidance on how notified bodies should handle high-risk in vitro diagnostics and legacy devices under the new regulations.
- In the IVD guidance, MDCG sets out how notified bodies can meet the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements to verify product batches of high-risk class D diagnostics. The guidance includes best practices for notified bodies to follow when carrying out conformity assessment procedures for class D IVDs.
- The group's other recent guidance document addresses the surveillance of legacy devices that came to market under the old directives, including details of manufacturer obligations related to the maintenance of quality management systems.
IVDR sets out specific requirements for class D IVDs, a grouping that covers diagnostics used in areas that are of high risk to the patient and public health. Notified bodies need to verify product batches of class D IVDs, meaning manufacturers need to forward batch test reports and provide access to samples of their products. The notified body should ask an EU reference laboratory (EURL) to carry out the batch testing.
The MDCG guidance fleshes out the role notified bodies play in the process and provides best practices. Notified bodies need documented procedures for the verification process, the establishment of a test plan, and reaching agreements with manufacturers on when and where sample or batch testing is done.
MDCG expects notified bodies to create a testing plan for each class D IVD and share it with the EURL. The plan should be based on the results of the notified body's conformity assessment, as well as the performance verification opinion of an EURL and any other relevant information. The guidance permits the EURL to "propose justified changes based on its scientific expertise."
Other sections of the guidance cover the agreement between the notified body and manufacturer. The guidance states the agreement should include the EURL-approved test plan, details about the logistics of sample sharing, the provision of batch release quality control results from the manufacturer and more.
MDCG published the IVDR guidance the day before issuing a document about the surveillance of legacy products that came to market under the old device directives. Transitional arrangements allow devices with valid certificates under the directives to stay on the market until 2024, despite the Medical Device Regulation now applying.
As the guidance explains, "in principle, the quality management system approved under the directives needs to be maintained." However, the Medical Device Regulation (MDR) states new requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators apply to legacy devices.
In light of that fact, MDCG is asking notified bodies to verify if manufacturers have adjusted their quality management systems according to the rules on significant changes and if they have brought procedures for post-market surveillance and the other areas where MDR applies in line with the regulation. Once the documentation review is complete, the notified body should use the findings to inform the audit plan.
MDCG's latest guidance documents continue the stream of updates about IVDR and MDR. Last week, the European Commission published an updated joint implementation plan for IVDR that reflects the move to a phased implementation of the requirements.
Despite IVDR's recent extension of certification timelines beyond the formal date of application in May 2022, there continues to be a shortage of notified bodies as the European regulatory environment enters the first full calendar year of MDR and the introduction of IVDR.
"Prior to IVDR and its new concept of classifications, only ~20% of IVDs had to undergo an assessment of conformity by a notified body. Now as many as ~80% will need a notified body assessment," according to healthcare data science company IQVIA. "Even if the notified body shortage begins to recede in the back half of 2022, clinical (performance evaluation) requirements and post-market requirements will present significant challenges for both MedTech and IVD manufacturers."