Annex XIV of the European MDR and clinical development plans for medical devices

Annex XIV of the Medical Devices Regulation (EU) 2017/745 (MDR), section 1(a), 8^th indent, requires a Clinical Development Plan (CDP). Some manufacturers may need more clarity, though, in order to meet CDP requirements as part of their broader MDR compliance efforts.

The CDP is not defined in Article 2 of the MDR, and the ISO 14155 standard on medical device clinical investigations also does not provide clarity on what is expected in terms of such a plan. Furthermore, the European Medical Device Coordinating Group (MDCG) has not issued guidance on what they expect to see in the CDP. However, the CDP is specified in Annex XIV, and should result in a thorough clinical evaluation report (CER). This post is intended to help understand how a CDP should be structured.

CDP for new versus existing medical devices

For a new device for which clinical evidence must still be compiled, it would make sense to set out how pre-clinical data, first-in-man studies, feasibility, pilot and pivotal studies can follow upon each other to create the evidence. For existing devices the content of the CDP appears less obvious. These devices are already certified, so the steps mentioned above should already have been taken and the results should be covered in the CER.

MDCG guidance 2020-6 on clinical evidence needed for medical devices previously CE Marked under Directives 93/42/EEC or 90/385/EEC sets out that most of the CDP aspects do not apply for legacy devices, except for the post-market clinical follow-up (PMCF) plan. In the PMCF plan, milestones and acceptance criteria should be listed.