The new regulations for in vitro diagnostic medical devices (IVDR) entering EU market will come into force on 26th May 2022. If you’re planning to export your IVD medical device to the EU and haven’t already familiarised yourself with the upcoming regulatory changes, this is the right time to do it.
Some of the key changes will include:
Reclassification of devices according to risk - risk classes will range from Class A for low-risk devices to Class D for high-risk devices. Only class A devices can self-certify. This means that 80-90% of IVDs will no longer be able to self-certify. Many devices will be up-classified into higher risk groups.
New requirement for clinical evidence - manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance. This will need to be documented in Performance Evaluation Plan and Report, which will assess scientific validation, analytical performance and clinical performance. Any claims will need to be supported by evidence.
Notified body review of technical document– the process will be at the same depth for all devices, but there will be sampling proportionate to risk with no sampling for higher risk devices with no sample for Class D devices.
Requirements for Person Responsible for Regulatory Compliance (PRRC) and an Authorised Representative (AR) –for small and micro companies, the PRRC can be outsourced, and the AR needs to be based in the EU.
Implementation of unique device identification (UDI) which will feed into the Eudamed Database for better traceability and recall.
Requirements for post market surveillance – post market performance follow up (PMPF) will be required as part of the post market surveillance plan, and the manufacturer will be expected to proactively collect and evaluate performance and relevant scientific data from the use of the device throughout its lifetime.
No “grandfathering” provisions – all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.
Medilink’s Regulatory Team can work with you and support you in your transition towards compliance with the new IVDR, whether through a one-day gap analysis day with a clear output of prioritisation of work and a plan to move forward, a clinical evaluation report, regulatory submissions or other bespoke requirements. Contact us today at email@example.com.
To find out more about the IVDR, please click here.