The clinical evaluation is an essential component of the technical documentation and a pre-requisite for the fulfilment of the essential requirements, hence absolutely necessary to certify medical devices or place them on the market in accordance with the law. The aim is always the CE marking of a medical device to place it on the European market – and, in the end, also on the worldwide market. Furthermore, the clinical evaluation must be maintained and updated regularly.
The updated guideline (MEDDEV 2. 7/1 rev. 4), the harmonized standard "Clinical investigations of medical devices for human subjects - Good clinical practice" (EN ISO 14155) as well as an established approval procedure for clinical investigations according to MPKPV (Ordinance on Clinical Trials with Medical Devices), specify the guidelines for the implementation of the clinical evaluation. With the new Medical Device Regulation, these requirements have once more been intensified.
An essential change for clinical evaluations is, for example, that manufacturers can now rely on comparable products,, or have full access to the information about a such comparable products, only under strict conditions.
Clinical data providing information on safety and performance of high-risk devices and implants should be generated from clinical studies. An evaluation based on a literature research alone will only be possible to a limited extent in the future.
MDSS Consulting GmbH draws up the clinical evaluation individually for your medical device. Furthermore, we offer regulatory support with carrying out clinical studies.
If you like to receive further information, please use our contact form. The MDSS Consulting GmbH team is looking forward to hearing from you!