K7. Clinical Evaluation Plan
As part of the clinical evaluation and post-market clinical follow-up (PMCF), it is necessary to plan, continually conduct and document a clinical evaluation.
If the clinical investigation is part of the clinical evaluation plan (CEP), as referred to in appendix XIV of the MDR, you may refer to details from or refer to the CEP in the documentation. The CEP is mandatory for clinical investigations in the context of conformity purposes (MDR article 62/74.2) or for PMCF studies (MDR article 74.1).