CLINICAL EVALUATION
Professional support for Clinical Evaluation
The clinical evaluation is a key component of the technical documentation and a requirement for placing medical devices on the market under Regulation (EU) 2017/745 (MDR). Taking into account all regulatory aspects, MDSS Consulting GmbH can provide you with individualised assistance in the clinical evaluation of your medical device.
Overview of our services:
Use of templates
Gap analysis
Literature search for clinical evaluation
Revision of a clinical evaluation
New clinical evaluation
Clinical evaluation – what is it actually for?
A medical device must be safe and provide its intended clinical benefit and performance during normal, intended use.
Demonstrating these aspects is the primary goal of the clinical evaluation. It is therefore a vital part of the technical documentation and a prerequisite for meeting the general safety and performance requirements outlined in Annex I of Regulation (EU) 2017/745 (MDR).
A clinical evaluation must be performed for every medical device, regardless of its risk class, in order to complete the conformity assessment procedures described in Article 52 of the MDR.
It is a systematic and planned process, defined in a clinical evaluation plan (CEP), which describes how clinical data is to be generated, compiled, analysed, and ultimately evaluated.
The scientific analysis and critical assessment of the data are documented in the clinical evaluation report (CER).
Clinical evaluation is not a one-time task ‒ it is a continuous process that spans the entire lifecycle of a medical device.
Regulatory requirements for clinical evaluation
With the introduction of the MDR, the requirements for clinical evaluation have become significantly stricter compared to the former Medical Device Directive 93/42/EEC (MDD). The current requirements are outlined in Article 61 and Annex XIV (Part A) of the MDR.
Several MDCG guidance documents (guidelines of the European Commission) further specify these requirements and provide practical assistance for the preparation and updating of clinical evaluations. The still widely used guidance MEDDEV 2.7/1 rev. 4 is currently being transitioned into a corresponding MDCG guideline. In addition, the upcoming ISO 18969 “Clinical evaluation of medical devices” is under development. It aims to define general terminology, principles, and processes related to clinical evaluation. These regulatory frameworks are intended to support the assessment of clinical risks associated with a device and the acceptability of such risks in light of the clinical benefit during intended use.
If sufficient and high-quality clinical data cannot be obtained to demonstrate safety and performance or clinical benefit ‒ e.g., from scientific literature ‒ manufacturers may need to generate the necessary data through clinical investigations. In such cases, the standard EN ISO 14155 “Clinical investigation of medical devices for human subjects – Good Clinical Practice” must be followed. Additionally, national regulations may apply, such as the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) in Germany.
Would you like to find out more or do you already have a specific project in mind?
You are welcome to take advantage of our free initial consultation*.