Applying for a CE Marking or have one already?

In both the cases, CER would be created or updated per MEDDEV 2.7/1 Revision 4 (June 2016). Non compliance to this new revision of the MEDDEV has resulted in difficulty in getting a CE or the CE of an existing product going on hold.

Common pitfalls resulting in non compliance:

1. Insufficient qualification of Evaluator:

Your CER Evaluator should have experience of 10 years, experience with similar device or in the clinical area of application, and a signed declaration statement declaring no conflict of interest. Author and Evaluator should be different people, and the qualification requirements are mostly for the Evaluator who finally signs off on the CER. This person is typically someone with 10 years of documented professional experience or 5 years with degree from higher education.  

2. Unsubstantiated equivalence:

Equivalence with preexisting CE Marked device should be one on one and any differences must be justified for no impact on safety, leveraging literature survey, clinical studies or established scientific principles or clinical practices. A detailed study of the competitors and how your the Manufacturer’s device relates to them is the key.

3. Missing RBA:

A Risk Benefit Analysis (RBA) allows the Manufacturer to adopt a holistic approach to medical device safety. Individual RBA and overall RBA should be tied in with the CER and is important to demonstrate that risk has really been lowered As Far As Possible (AFAP) which is also required per ISO 14971:2012. A comprehensive risk assessment and RBA uncover the risks which regulatory bodies can raise as a concern for the device so that the Manufacturers can preemptively address those risk through the CER. Finally, thorough risk documents result in a thorough CER.

4.  Superficial utilisation of post market data:

Several regulatory databases like FDA MAUDE or European Database on Medical Devices (EUDAMED) should be fully studied and utilized to gather the performance of these or similar devices in the market when writing the CER. If the product has been sold in different countries complaint database should also be utilized. Since these are regulatory intelligence databases, regulatory authorities do tend to refer to this data and can ask questions around the common issues observed, which when studies properly can be used for preparing a strong CER.

The CER is a live document and should be updated with the risks associated with the use of the device as Manufacturers become aware of them at the post-market stage. Elexes helps medical device manufacturers, aspiring for CE marking, by creating an organized Technical File of which a comprehensive Clinical Evaluation Report (CER) is a critical part. For any questions/comments please write to jennifer@elexes.com.