Clinical Evaluation data (MEDDEV 2.7/1 rev 4)

The CER (Clinical Evaluation Report)

 “The significance of compliant Clinical Data as part of your regulatory strategy, is more important now than at any previous time…”

Your CER (Clinical Evaluation Report) is the single most important part of your CE Marking data submission and the area in which you are most likely to have a Notified Body non-conformance raised. 

Clinical Data is mandatory for ALL Classes of Medical Device-no exceptions

Whether your Medical Device is Class I  or IIa or IIb or Class III, Clinical Data including a Clinical Evaluation Report (CER) in accordance with the requirements of MEDDEV 2.7/1 rev 4, is a mandatory requirement......there are NO exceptions!

Peace of mind that your CER is compliant

With our 40+ years of experience of Medical Device compliance, with special focus having been on auditing Clinical Data on behalf of UK Notified Bodies..........

.......we are perfectly placed to give you the assurance you need, that your Clinical Evaluation Data meets the MEDDEV 2.7/1 rev 4 requirements.

Whatever level of assistance you need to complete your CER, it is available....

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Medical Device Regulatory Solutions


0161 870 6751