Clinical - Evaluation Reports (CER)
Clinical Evaluation is a critical part of ensuring Medical Devices are safe, and perform as intended both before and after entering the market.
The EU and UK require all types of medical devices to have a Clinical Evaluation, which is evidenced in a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER).
In the UK, Clinical Evaluation must meet the stipulations of Annex X of the Medical Device Directive 93/42/EEC and be compliant with the UK Medical Device Regulations 2002 (as amended).
The Clinical Evaluation that applies to the EU must take into account Article 61 and Annex XIV of EU Medical Device Regulation 2017/745.
What is required for Clinical Evaluation?
Clinical Evaluation requires examination of all the information gathered, from various sources. It is vital to analyse and assess all the data obtained in order to make an informed decision.
To validate the product’s design, to prove that it works and performs as intended.
Evaluation of biological responses to a patient contacting device can provide information that can help understand the impact of such a device. It can yield insights on how it can affect the body, and any relevant medical responses to its presence.
Risk Management activities (ISO 14971).
Pre Clinical Studies -Any preliminary research examining the efficacy of a medical treatment should be conducted prior to clinical studies. Such preclinical work can inform us of potential positive or negative outcomes that may arise following human trials.
This clinical literature review is examining the relevance of any clinical studies that show whether the device is suitable for clinical use compared to similar items available on the market, and taking into account any clinical investigations that have been conducted regarding the device.
After a device has gone on the market, Post Market Surveillance should be conducted to ensure its ongoing safety. Clinical Follow Up data should provide supportive evidence for its clinical history.
Clinical Evaluation and reports must be updated regularly, potentially every two years or sooner, depending on the complexity of the device at hand. Devices with heightened risk may require additional updates.
EOMI Consultancy has helped medical device manufacturers in UK and abroad with their clinical evaluations. Our Consultants will help with
a. Clinical Evaluation Plan (CEP)
b. Analysis of clinical data
c. Appraisal of clinical data
d. Demonstration of Equivalence
e. Literature Search and Review
f. Clinical Evaluation Report
Applicable Standards
- EN ISO 13485: 2016 CL 8.2.1 Customer Feedback
- EN ISO 14971:2012 Risk Management
- NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS)
- MEDDEV 2.12-1, Rev 8Guidelines on a Medical Device Vigilance System
- MEDDEV 2.12-2, Rev 2 Guidelines on Medical Devices. Post Market Clinical Follow-Up Studies Post Market Clinical Follow-up Studies
- MEDDEV 2.7.1, Rev 4Clinical Evaluation
- MDR 2017/745: Medical Device Regulation of the European Parliament and the Council of 5 April 2017 on medical devices.
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