All devices, regardless of classification, are required by Article 5, 3. to fulfil the clinical requirements of Article 61 and Part A of Annex XIV.
Start by developing a clinical evaluation plan (See Annex XIV, Part A). Whether or not the clinical evaluation will have to include a clinical trial or “investigation” will depend on several factors. Not only the classification of the device, but also how novel the device is and the amount of clinical data on equivalent devices already available in published literature. For devices in the higher classifications (IIb and III), it is also possible to consult a panel of EU experts to determine the clinical evaluation requirements (Article 61, 2).
If one or more clinical investigations are needed, they must be planned, approved, conducted and reported in accordance with the procedures in Articles 62-81 and Annex XV. Similar to the situation that exists with risk management: The clinical evaluation doesn’t end with a positive report on the clinical utility of the device. The final step in the clinical evaluation process is preparation of the post-market clinical follow-up plan (See Annex XIV, Part B).
Deliverables for demonstrating compliance:
(1) The Clinical Evaluation plan and report,
(2) Clinical Investigation documentation (if applicable),
(3) The Post Market Clinical Follow-up (PMCF) plan.