All IVDs, regardless of classification, are required by Article 5, 3. to fulfil the performance requirements of Article 56 and Part A of Annex XIII.
Start by developing a performance evaluation plan (See Annex XIII, Part A). Whether or not the performance evaluation will have to include a trial or “study” will depend on several factors. Not only the classification of the device, but also how novel the device is and the amount of performance data on equivalent IVDs already available in published literature.
If one or more performance studies are needed, they must be planned, approved, conducted and reported in accordance with the procedures in Articles 57-77 and Annex XIII and potentially Annex XIV.
Similar to the situation that exists with risk management: The performance evaluation doesn’t end with a positive report on the performance of the device. The final step in the performance evaluation process is preparation of the post-market performance follow-up plan (See Annex XIII, Part B).
Deliverables for demonstrating compliance:
(1) The Performance evaluation plan and report,
(2) Performance study documentation (if applicable),
(3) The Post Market Performance Follow-up (PMCF) plan.
Guidance
Guidance is also available from the Medical Device Coordination Group;
on performance evaluations, including of software;
- MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs).
- MDCG 2020-1 Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software.
and on conducting performance studies;
- MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746.
- Appendix to MDCG 2024-4 Performance Study Summary Safety Reporting Form.
- MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746.
- MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746.
- MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).