Clinical Evaluation & Studies - MEDDEV MDR Klasse III

Support Clinical Evaluation & Studies MEDDEV MDR Class III

Clinical Data vs. Clinical Evaluation vs. Performance Data

For each Medical Device, the safety and performance — including clinical benefit — must be verified through a Clinical Evaluation. This evaluation is based on Clinical Data, which can be generated either by clinical investigations of your own device or by demonstrating equivalence to an existing device. Equivalence must be proven in terms of clinical, technical, and biological characteristics, as outlined in MDR, Annex XIV, paragraph 3. The Performance Data refers to how well your device delivers the expected clinical benefit.

The European Commission has published a MEDDEV 2.7 1 Guideline on this subject, which is currently still the most important document in this area under the European Medical Device Regulation. We support you in the preparation and implementation of this Clinical Evaluation.

What is a Clinical Evaluation?

According to the MDR, a Clinical Evaluation may consist of:

A critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device
A critical evaluation of any available clinical investigations

For implantable devices and Class III devices, a clinical investigation is often mandatory, unless existing clinical data can sufficiently justify safety and performance.

Legal Framework under MDR and Key Guidance Documents

Article 10 of the MDR requires manufacturers to perform a Clinical Evaluation for all Classes of devices (Class I, IIa, IIb, and III). The requirements are further detailed in Article 61 and Annex XIV, which also include Post-Market Clinical Follow-up (PMCF) as part of the broader Post-Market Surveillance (PMCF).

Details on how to carry this out can be found in particular in:

MDR Annex XIV
MDCG (Medical Device Coordination Group) Papers 2020-5 and 2020-6
MEDDEV 2.7/1 Rev. 4 Guide

These documents describe how a Clinical Evaluation should be structured and which elements are necessary to demonstrate conformity with the Essential Safety and Performance Requirements according to MDR, Appendix I (in particular sections 1 and 8).

In summary, the Clinical Evaluation may consist of a Clinical Evaluation Plan and Report, which include the following elements:

Scope of application (clear identification and description of the product, including purpose, indications, contraindications, target groups, users, clinical benefit)
Clinical Development Plan (identification of existing and necessary data)
Equivalence Assessment (evaluation of the similarity of the product to equivalent products, taking into account clinical, technical and biological parameters, evaluation of existing differences)
Systematic and transparent research of currently available scientific literature to map the established state of the art and to verify the clinical efficacy and safety of equivalent products
Description of all relevant positive and negative results and their analysis in terms of relevance and significance in relation to the medical device under evaluation
Conclusions regarding the safety and clinical performance of the device, including its clinical benefit (performance)

WQS has been providing Clinical Evaluation support for Medical Devices for over 30 years. We can support Class I, IIa, IIb and III Medical Devices and would be happy to provide a non-binding quote for this service.

Clinical Evaluation Plan and Report

In summary, the Clinical Evaluation may consist of a Clinical Evaluation Plan and Report, which include the following elements:

Scope of application: clear identification and description of the product, including purpose, indications, contraindications, target groups, users, clinical benefit
Clinical Development Plan: identification of existing and necessary data
Equivalence Assessment: evaluation of the similarity of the product to equivalent products, taking into account clinical, technical and biological parameters, evaluation of existing differences
Systematic and transparent research of currently available scientific literature to map the established state of the art and to verify the clinical efficacy and safety of equivalent products
Description of all relevant positive and negative results and their analysis in terms of relevance and significance in relation to the medical device under evaluation
Conclusions regarding the safety and clinical performance of the device, including its clinical benefit (performance)