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:
- EU MDR compliance resource center
- European Authorized Representative (EC REP) in-country representation
- Process chart: EU MDR CE Marking certification for medical devices
Related services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies