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.

Devices for which CDP obligations are less clear

For devices that have been on other markets but that will obtain CE Marking under the MDR, as well as for devices that are already CE-Marked under the MDR, the CDP situation is not clear. On the one hand, the exception for legacy devices does not apply; on the other hand, one of the key characteristics of a “plan” is that it addresses something that still needs to happen.

With this in mind Emergo recommends that manufacturers develop their CDPs to summarize the history of clinical evidence, with reference to reports, plus any activities that are still planned. The CER can be used to expand on that evidence and weigh the clinical benefits against the risks. Over time the summary history section of the CDP will grow, while the rest becomes more focused only on PMCF. The CDP will therefore provide the Notified Body reviewer with a guide to how the clinical evidence for a device has been constructed.

Additional European MDR resources from Emergo by UL:

• European Authorized Representative (EC REP) in-country representation
• Process chart: EU MDR CE Marking certification for medical devices