Clinical Evaluation
Clinical Evaluation – what is it used for?
A medical device must be safe and demonstrate its clinical benefit and performance during normal, intended use.
Providing evidence for these aspects is the primary objective of the clinical evaluation.
It is therefore an essential part of the technical documentation and a prerequisite for fulfilling the General Safety and Performance Requirements (GSPRs) outlined in Annex I of Regulation (EU) 2017/745 (MDR).
Clinical evaluation must be carried out regardless of the device’s risk class, as it is necessary to complete the conformity assessment procedures described in Article 52 of the MDR.
It is a systematic and planned process, which is defined in a Clinical Evaluation Plan (CEP). The CEP outlines how clinical data for a medical device is to be generated, compiled, analyzed, and ultimately evaluated.
The scientific assessment and critical appraisal are summarized in the Clinical Evaluation Report (CER).
Clinical evaluation is to be understood as a continuous process that extends throughout the entire lifecycle of a medical device.
Regulatory requirements for a clinical evaluation
With the MDR, the requirements for clinical evaluations have become significantly more stringent in many respects compared to the Medical Devices Directive 93/42/EEC (MDD). The requirements are described in Article 61 and Annex XIV (Part A).
Several MDGG guidelines (European Commission guidelines) clarify these requirements and provide assistance in preparing or updating clinical evaluations. The MEDDEV 2.7/1 rev. 4 guideline, which is still largely valid, is also currently being converted into an MDCG guideline. Furthermore, ISO 18969, “Clinical evaluation of medical devices,” is currently being developed. This standard defines general terminology, principles, and procedures for the clinical evaluation of medical devices. These regulations are intended to help assess the clinical risks associated with a device and evaluate the acceptability of these risks in the context of the clinical benefit when the device is used as intended.
If clinical data to demonstrate safety and performance or clinical benefit are not available in sufficient quantity or quality (e.g. in scientific literature) and manufacturers must collect this data as part of clinical trials, the standard “Clinical Trials of Medical Devices on Human Subjects – Good Clinical Practice” (EN ISO 14155) and the MPDG (Medical Device Law Implementation Act) must also be observed.
Support in clinical evaluation
Taking all of the above-mentioned aspects into account, MDSS Consulting GmbH, with a team of experienced experts, can provide you with individual assistance in the clinical evaluation of your medical device:
