A medical device must be safe, and live up to its medical benefit and performance under normal, intended use. The main goal of the clinical evaluation is the demonstration of these aspects. Therefore, the clinical evaluation is an essential component of the technical documentation and a prerequisite for fulfilling the essential safety and performance requirements. Hence, it is obligatory in order to certify medical devices of all risk classes within the law, and to place them on the market.
The clinical evaluation is a systematic and planned process, which generates, compiles, analyzes and finally evaluates data for a medical device. It consists of a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER). As a result, the clinical evaluation is considered an ongoing process extending across the entire life cycle of a medical device. Compared to the Medical Device Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (Medical Device Regulation, MDR) has in many respects significantly tightened the provisions in regards to the clinical evaluation. Several MDCG guidelines (Guidelines of the European Commission), as well as major parts of the MEDDEV 2.7/1 Rev. 4, specify these provisions and provide support with creating or updating the clinical evaluation. Additionally, current requirements and specifications for creating a clinical evaluation are described in the MPDG (Medizinprodukte-Durchführungsgesetz).
If clinical data for demonstrating safety and performance or the clinical benefit is not available in sufficient quantity or quality (e.g. in scientific literature), and if manufacturers must collect this data within the framework of clinical investigations, the standard “Clinical investigation of medical devices for human subjects – Good clinical practice” (EN ISO 14155) must be taken into consideration.
Considering all those aspects, MDSS Consulting GmbH, with its team of experienced experts, will be happy to create the clinical evaluation tailored to your medical device – for all risk classes.
As part of an update, a gap analysis of an already existing clinical evaluation may be helpful in a first step, in order to identify existing gaps and to fill them more easily.
The competent staff of MDSS Consulting GmbH will be happy to support you also in case of an extensive revision of a clinical evaluation, to bring it up to date and make it meet the current requirements.
Feel free to contact us so we can find a suitable solution together.