To support the diagnostics sector, the Medical Device Coordination Group (MDCG) has released an updated Q&A document regarding the transitional provisions for the certification of Class D diagnostics. This update is crucial for manufacturers and stakeholders navigating the complexities of regulatory compliance under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Class D diagnostics are the highest risk category of in vitro diagnostic medical devices (IVDs), typically involving tests that can have serious implications for patient health, such as those used for detecting life-threatening conditions. The IVDR, which came into effect in May 2022, introduced stricter requirements for the approval and monitoring of these devices, aiming to ensure enhanced safety, efficacy, and reliability.
The MDCG’s updated Q&A document clarifies various aspects of the transitional provisions, providing essential guidance for manufacturers, including:
- Emphasizing the transition period during which existing Class D devices may continue to be marketed. Manufacturers are urged to apply for certification under the IVDR as soon as possible, but the Q&A clarifies that devices certified under the previous IVD Directive (IVDD) can be placed on the market until their certificates expire, provided they are compliant with the new regulations.
- Outlining specific scenarios in which transitional provisions apply, detailing the requirements for manufacturers to demonstrate compliance, including clear timelines for submitting applications to notified bodies and maintaining records that prove the devices meet current safety and performance standards.
- Clarifying the role of notified bodies in the certification process, underscoring the importance of collaboration between manufacturers and notified bodies to facilitate a smooth transition.
- Insights into how the new regulations affect existing Class D diagnostics already on the market, such as the necessary steps for re-evaluation and certification under the IVDR and recommendations for conducting post-market surveillance and vigilance to ensure ongoing compliance.
By clarifying regulatory expectations and outlining the steps for compliance, the MDCG is fostering a more robust and reliable framework for in vitro diagnostic devices. As the industry adapts to these changes, the emphasis on safety and performance remains paramount, ultimately benefiting patients and healthcare systems across Europe.
See Q&A document here.
