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 Evaluation.
According to the MDR it may consist of:
For implantable devices and Class III devices, a clinical investigation is often mandatory, unless existing clinical data can sufficiently justify safety and performance.
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:
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 (CEP) and Clinical Evaluation Report (CER), which include the following elements:
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 Data is information about a device’s safety or performance, including clinical trial results or scientific literature. Clinical Evaluation is the process of evaluation of this data for compliance with the requirements of the MDR. Performance Data refers specifically to how well the device achieves intended clinical benefit.
Yes, MEDDEV 2.7/1 Rev. 4 is still considered the most relevant guidance for Clinical Evaluation under MDR. While it predates MDR, it remains widely used and is referenced in MDCG documents for structuring evaluations and reports.
A Clinical Evaluation includes a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER). These documents outline the scope, intended purpose, clinical development plan, equivalence assessment, literature review, data analysis and final conclusions on safety and performance.
Start by assessing the availability of Clinical Data, defining the intended purpose and claims of your device, and determining whether a clinical investigation is needed. WQS can guide you through each step and provide a tailored, non-binding quote.
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Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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