The MDCG 2022-19 and MDCG 2022-20 application documents are welcome Christmas presents to IVD performance studies.
Any IVD manufacturer who has started to run performance studies in Europe since May 2022 will tell you it is a painful process as you have to approach each Member State individually. This is even more complicated for CDx studies where pharma and diagnostic applications must apply separately. While there is no sign of a pan-European system, there is now some hope that there should be consistency in the application process.
The sponsors of IVD performance studies must submit an application or notification to the EU Member States in which their study will be conducted, accompanied by the documentation described in IVDR Annex XIV Chapter I. Additionally, if a modification to the performance study is planned, that will substantially impact the safety, health, or rights of the study participants or the study data. In that case, the study sponsor is required to notify the applicable EU Member States. The study sponsor must submit the initial application/notification and a notification of a substantial amendment to the EU Member States via the European database on medical devices (EUDAMED).
As the EUDAMED module for performance studies is not fully functional, on December 12th, the MDCG published MDCG 2022-19, which provides IVD performance study sponsors with a series of performance study application/notification documents, which have been created to support the performance study procedures with respect to IVDR. The documents provided within MDCG 2022-19 are:
- A performance study application/notification form under the IVDR
- Templates for addendums to the performance application/notification form for additional performance devices, additional comparator devices, and additional sites
- An appendix of documents to attach with the performance study application/notification
- A checklist of general safety and performance requirements, standards, common specifications, and scientific opinions
The MDCG followed on December 14th by publishing MDCG 2022-20, which provides a template for 'Substantial modification of performance study under Regulation (EU) 2017/746'.
The MDCG state that the documents provided within MDCG 2022-19 and MDCG 2022-20 are intended to be facilitative, and their use by the competent authorities and sponsors is encouraged. However, it is essential to check with the individual Member State where the performance study is planned to be conducted for any specific national requirements. As MDCG 2022-19 and MDCG 2022-20 state that the application/notification form and the substantial modification template provided align, as far as possible, with the EUDAMED data fields, it is hoped that 'any specific national requirements' will be limited. To reduce any additional burden upon IVD performance study sponsors imposed due to the delay in a fully functional EUDAMED.
The documents provided by the MDCG are a welcome Christmas present to IVD performance study sponsors as it goes towards filling the vacuum created by the absence of EUDAMED. However, as an additional Christmas bonus, we look forward to the Commission making the 'list of national points of contact' available on their website, promised within MDCG 2022-12. To facilitate and streamline communication of sponsors of IVD performance studies with relevant points of contact within each EU Member State that can specifically address queries related to performance study applications.
If you want more information about IVD or CDx performance studies, don't hesitate to contact
us. There is also a unique opportunity to meet the IVD team in-person in the UK on the 1st of February, during the event; Going global with your IVDs