The clinical evaluation is required for each medical device regardless of its classification.

The clinical evaluation plays a major role when it comes to development and market introduction of medical devices. It is key element of the technical documentation and legally embodied in the German Medical Devices Act.

§19, section 1 of the medical product law and appendix X of the EU guidelines 93/42/EWG require that the suitability of all medical products be proven with respect to their designated use based on clinical data.

Clinical data are either derived from literature or experience databases  or have to be generated by a clinical investigation. The clinical evaluation is required for each medical device regardless of its classification.

The clinical evaluation is a continuous process and needs to be kept up-to-date over the entire product life cycle.

Documentation of the Clinical Evaluation

Benefit from the MedSysCon experience in creating regulatory compliant clinical evaluations. According to MEDDEV guideline 2.7.1, the clinical evaluation of medical products may be based on data taken from scientific literature if certain prerequisites apply, such as the technical equivalence to established and certified products.  The clinical evaluation of the further development of existing products can also, in many cases, be based on literature. If your products can be evaluated in this way, we are also able to provide the complete clinical evaluation.

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MedSysCon: Klinische Bewertung

Clinical Evaluation

The clinical evaluation is required for each medical device regardless of its classification.

Your Benefits

We support you regarding the use of clinical data for your product approval or post-market strategy.

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