Essentials of European Medical Device Regulatory Affairs

Clinical Evaluation The contents of a clinical evaluation report (CER) are described in a MEDDEV. The clinical evaluation report will contain • Scientific literature of equivalent devices • Results of clinical investigations • Device should be discussed in the context of alternative treatments.

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For Class III and Class IIb devices the company can ask the clinical expert panel for advice on the development strategy and about the planned clinical investigation.

The panel’s advice needs to be recorded in the CER.

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Clinical Evaluation Clinical investigations(CI) are expected for implantable and class III devices unless it is duly justified to rely on existing clinical data MDD Annex X directive 93/42/EEC MDR exceptions are now…… -------------------------------------------------------------------------------------- if it is a modification of a device by the same manufacturer. The NB will check the post marketing clinical follow up (PMCF) plan contains appropriate post marketing studies to demonstrate safety and performance of the device. --------------------------------------------------------------------------------------- Where date was generated under the MDD and meets a common specification ---------------------------------------------------------------------------------------- is on the list of well understood products e.g. dental braces. ---------------------------------------------------------------------------------------- If equivalent to another manufacturer’s MDR compliant device and contract allows access to the technical file. ----------------------------------------------------------------------------------------- Article 61 (10) if clinical data is not appropriate ----------------------------------------------------------------------------------------- And that modification creates an equivalent device to the first device and the NB agrees it is equivalent and the clinical evaluation of the original device would cover the modification.

Any justifications for not conducting a CI are included in the CER.

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