Notified Body surveillance of legacy devices under the IVD Regulation

EU issues guidance on surveillance of IVDs on the market with certificates under the Directives

The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU 2017/746) permits devices covered by valid certificates issued by a Notified Body under the IVD Directive (98/79/EC) to be placed on the market or put into service after the date of application of the IVDR, and no later than 26 May 2025, under certain conditions. This is covered by the transitional provisions in Article 110(2) and 110(3) of the IVDR. The guidance describes such devices with the term ‘legacy devices’.

The conditions require that the Notified Body that issued the CE Certificate under the IVDD continues to perform surveillance of the devices that it has certified. The Medical Device Coordination Group (MDCG) has issued guidance to clarify the expectations of appropriate surveillance under these provisions (MDCG 2022-15). As with all MDCG guidance, it is stated that the document cannot be regarded as reflecting the official position of the European Commission and is not legally binding. While the guidance describes activities to be performed by Notified Bodies, it also covers requirements in relation to some manufacturers obligations, especially regarding their Qquality Management System (QMS). The guidance has been drafted aligning with similar guidance for the Medical Devices Regulation (MDR) (EU 2018/745) contained in MDCG 2022-4.

IVDs covered by valid certificates under the IVD Directive can continue to the placed on the market or put into service provided that they continue to comply with the Directive and there are no significant changes in the design and intended purpose. Furthermore, all relevant requirements in the IVDR on post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices apply to ‘legacy devices’ in place of the corresponding requirements in the Directive. Therefore, manufactures of legacy devices need to maintain the QMS approved under the Directive whilst incorporating the applicable provisions of the IVDR into that QMS. IVDR requirements that are not related to registration of economic operators and devices, post-market surveillance, market surveillance and vigilance should not apply in respect to legacy devices.

Notified Body activities regarding legacy devices should be a continuation of the previous surveillance activities under the Directive. The Notified Body needs to identify existing IVDD certificate(s) that will continue to be used and if their scopes remain unchanged. Additionally, in their surveillance activities, Notified Bodies need to take into account the new requirements arising from the transitional provisions. During its surveillance, the Notified Body needs to verify:

• If the scope of devices covered by the IVDD certificate(s) remains or if any such devices are discontinued.
• If the manufacturer has adjusted its QMS regarding making significant changes to devices.
• If the manufacturer has made the necessary adjustments to the QMS on post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.
• If all appropriate processes relating to post-market surveillance, including risk management and performance data, feed into the post-market surveillance plan

Manufacturers of legacy devices that continue to be placed on the market under certificates for the IVD Directive should take note of the new MDCG guidance. Such manufacturers should confirm that they have incorporated the applicable requirements of the IVDR into their QMS and be prepared for the surveillance activities that will be undertaken by the notified body.