Top Five Things To Know About Clinical Evaluations

Author: Trinity M Consulting, LLC. | | Categories: Regulatory Consultants , Regulatory Consulting Company , Regulatory Contractors


A Clinical Evaluation is used to demonstrate a medical device’s safety and performance and its overall positive benefit-to-risk ratio by analyzing clinical data. Clinical Evaluation is part of a series of guidelines dealing with questions of application of EU-Directives on Medical Devices.

If you are looking for a Clinical Evaluation report for your medical device, make sure to find a consultant who has experience in this field and can help you compile all the necessary data for a comprehensive report.

To provide more information on how to go about, Trinity M Consulting, LLC has compiled a list of the top five things to look for in a Clinical Evaluation report for your medical device.

1. Clinical investigation
To evaluate a medical device’s safety and/or performance, it is crucial to undergo clinical investigation, which entails a systematic investigation of one or more human subjects. We carry out clinical investigations in accordance with EN ISO 14155 (GCP) and in accordance with local regulations.

2. Clinical Evaluation report
A lot goes behind creating a Clinical Evaluation report that ensures safeguards public health. It is ideally based on several databases. These databases include scientific literature based on the clinical investigations done previously. They also include the published and unpublished reports on similar (evidently comparable) clinical experiences. 

A new medical device, on the whole, cannot be evaluated based on its partial equivalences. If equivalency is to be proven by pre-clinical bench testing and/or animal research, scientifically valid proof is required for the data’s transferability to human use.

3. Regulatory background
As per Annex 7/Annex X of Directive 90/385/EEC (AIMDD) and Annex I.I.6a of Directive 93/42/EEC (MDD), according to Annex 1.I.5a of Directive 90/385/EEC (AIMDD) and Annex I.I.6a of Directive 93/42/EEC (MDD), demonstration of conformity with the essential requirements must include a Clinical Evaluation. European Union member states are also expected to follow the guidelines, even though it is legally non-binding.

4. Post-market clinical studies
Upon approved labeling, periodic post-market clinical follow-up is to be monitored to ensure the clinical performance and safety of the device. At no point, can the data obtained from post-market clinical follow-up studies replace the pre-market data necessary to demonstrate conformity with regulatory requirements. 

PMCF (Post-market clinical follow-up) studies are part of the clinical post-market vigilance system and are studies that have to be conducted (in addition to any pre-market activities) after the device has been placed onto the market.

5. Scope for Clinical Evaluation
The decision to conduct post-market clinical follow-up studies must be based on identifying possible residual risks and/or the lack of clarity in long term clinical performance that may impact the benefit/risk ratio of a medical device. Post-market clinical follow-up studies are mandatory for innovative, medical, high-risk devices and products. In some cases, it is also applicable to medical devices where the CE mark was based on the literature route/equivalence approach. PMCF studies serve to generate data regarding complications and/or problems that become apparent after long-term use of the device.

If you’re looking to get a Clinical Evaluation carried out, reach out to Trinity M Consulting, LLC.

As Regulatory Consultants providing service remotely throughout the United States, we focus on providing exceptional customized services for the medical device industry and consulting services for regulatory affairs, project management, clinical research, and talent recruitment. 

Our mission is to provide competitive and professional consulting services for Medical Devices.

To learn more about the services we offer, please click here. To get in touch with us, please click here