5. More extensive clinical documentation

Documentation and reporting

The considerably more extensive reporting includes the results of the clinical evaluation, if necessary. including the clinical trial documents, as well as additional reports and plans such as the Clinical Development Plan and the Summary of Safety and Clinical Performance (SSCP). MEDDEV 2.7 / 1 rev. 4 also sets requirements. The clinical evaluation can also be tested in conjunction with risk management. In addition there are the documents of the clinical PMS, in particular the documents Post Market Clinical Follow-up (PMCF), Post Market Surveillance Plan / Report (PMS), Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP). , As part of the Post-Market Clinical Follow-Up for Class III and implantable devices, the Safety / Clinical Evaluation / Performance Summary Reports must be updated at least annually.