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.