Clinical Evaluation

Clinical Evaluation for Medical Devices

General Information

Clinical evaluation plays a key role in the conformity assessment procedure for medical devices. And with the recent changes to the European Medical Device Directive MDD 93/42/EEC by the new amending Directive 2007/47/EC, clinical data and the clinical evaluation become even more important. Companies must be in compliance by March 21, 2010.

The European Medical Device Directive outlines that “the confirmation of conformity.......must be based on clinical data.”. The evaluation of this data is referred to as ‘clinical evaluation’.

Hence, a medical device manufacturer who wants his product approved in Europe has to perform a clinical evaluation as a major part of the conformity assessment procedure, regardless of the classification. The documented clinical evaluation report must be part of the technical documentation for the device.

In general, a clinical evaluation must demonstrate the suitability of the device for the intended use. All available clinical data as well as the product-related risks must be analyzed and a critical assessment of risks and benefits must be provided.

A clinical evaluation can be based on data from scientific literature, research, and testing or clinical studies. A combination of data from the different sources is possible.

Furthermore, the MDD requires that the clinical evaluation must be actively updated with data obtained from the post-market surveillance.

The European Commission issued with the new guideline MEDDEV 2.7.1 Rev 3, December 2009, a detailed guide for manufacturers and Notified Bodies on how to perform and assess a clinical evaluation.

Our Services

According to the MEDDEV 2.7.1 guideline, the clinical evaluation should be conducted by a suitably qualified person with referenced qualifications and documented experience.

MT PROMEDT CONSULTING has a long-year experience in the preparation of clinical evaluation reports for a broad range of medical device categories. Our team of experts, including biologists, pharmacists, biomedical engineers, toxicologists, and medical doctors can evaluate the best strategy for your product and carry out the complete process of clinical evaluation for you. This comprises the following services depending on your needs:

Search, review, and compilation of scientific literature
Comprehensive analysis and discussion of sponsor´s clinical data if available
Review of data on similar devices and benchmarking devices
Review of vigilance data
Risk assessment
Compilation of the clinical evaluation report

We work in line with the European guideline for clinical evaluations MEDDEV 2.7.1. and can ensure that your clinical evaluation meets all European requirements.

Please contact us for more information or a proposal for preparing a clinical evaluation for your product.