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EU MDR Clinical Evaluation
EU MDR Clinical Evaluation is an important section required under EU Regulation 2017/745 to demonstrate that a medical device is safe, performs as intended, and provides clinical benefits to patients. As part of the CE Marking certification process, manufacturers must prepare and maintain comprehensive clinical documentation that includes an in-depth review of all relevant clinical data, literature, and post market experience.
Under Article 61 and Annex XIV Part A, the EU MDR Clinical Evaluation process requires manufacturers to systematically collect, appraise, and analyse clinical data to prove conformity with the General Safety and Performance Requirements (GSPRs). This process applies to all classes of medical devices, from Class I to Class III, and must be updated regularly throughout the product lifecycle.
A MDR compliant Clinical Evaluation provides solid scientific evidence for your device’s safety, performance, and effectiveness, supporting CE Marking approval and ongoing regulatory compliance. It also helps reduce the risk of non-conformities during Notified Body reviews and audits.
At I3CGLOBAL, our team of EU MDR consultants and medical experts specialises in preparing comprehensive Clinical Evaluation documentation, ensuring full alignment with MEDDEV 2.7/1 Rev. 4 and EU MDR 2017/745 requirements. We help manufacturers navigate complex regulatory pathways and maintain a robust clinical evidence strategy for European market access.
EU MDR Clinical Evaluation Documentation
In the new medical device regulation MDR 2017/745 all manufacturers have to face the monumental task of updating EU MDR clinical evaluation documentation for their entire product portfolio. This task must be completed before they provide technical documentation which includes the Clinical evaluation report to notified bodies for CE Certification.
It is understood from the enquires we receive every day across the Globe, that 60% of device manufacturers told us they have no strategy in place to remediate gaps in their clinical documentation or so far no process in place for literature search, Clinical evaluation report planning, data collection, etc., which are the essential elements of medical device CE compliance under the new MDR from May 2021.
Either during the MDR transition or new medical device CE Marking application with Notified Bodies, there continues to be confusion about these requirements laid down in MDR 207/745 article 61 worrying for manufacturers as it holds up the compliance process.
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MDD vs MDR Clinical Evaluation
The requirement to perform an Evaluation found in part I of Annex X of the Medical Device Directive (MDD) is inadequate with the expectations. Therefore, the EU authorities published a guidance document Meddev 2.7.1 rev 4 Guide for manufacturers and notified bodies.
In EU MDR Clinical Evaluation, the requirements can be found in Article 61 and Part A of Annex XIV. Part A is focused on the pre-market phase and is an extension of part I of MDD Annex X. While the evaluation is still less detailed than the current Meddev 2.7/1 rev 4 it states the requirement of (a) CEP (b) Evaluation of clinical data and (c) CER.
EU MDR Clinical Evaluation Consultant
Any organization unity brings success!! The regulatory compliance team working with clinical evaluation consultants (outsourced expert) helps to increase the overall quality of clinical evaluation report due to the extensive experience and skills of external consultant deployed for the project. Outsourcing allows regulatory staff to focus on other important day-to-day activities as well.
Any organization that does not have the correct in-house skills looking for CER Writing, Literature Search, or Technical Documentation can seek I3CGlobal EU MDR Consultant and CER writer‘s assistance. In MDR Article 61 & MEDDEV 2.7/1 Rev 4, we have the skills with cross-platform experience and in-depth knowledge to start a project immediately!
Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost you time, money, and finally no assurance of success. The coordination between clinical evaluation consultants and client team members is essential for successful completion.
EU MDR Consultants must need cross-platform expertise and in-depth knowledge of MDR Article 61 & MEDDEV 2.7/1 Rev.4.
Frequently Asked Questions
When to update EU MDR Clinical Evaluation Documents
EU MDR Clinical evaluation and safety check is a continuous process besides, (a) Change in device State of Art (b) Change in components (c) Annual Updates
Who is a CER Consultant? Can the consultant be an “Evaluator”?
Clinical evaluation consultant is an expert in regulation but not an expert in interpreting the clinical significance of the device. A Clinical Evaluator is the person (or persons) who is ultimately responsible to appraise and analyze the clinical data and consultant determine whether it is sufficient to demonstrate compliance with regulation and Notified Body requirements. An evaluator(s) should be a suitably qualified individual or a team who can indecently make final judgements about the data collected.
If I don't have access to a competitor's technical / clinical data, how can I demonstrate equivalence?
Manufacturer will need to have sufficient data to prove biological, technical, and clinical equivalence by way of bench testing reports, competitor’s labeling and IFU where many information that can be used to substantiate equivalence; indications, patient population treated, design characteristics, general device specifications, surgical technique, principles of operation, and constructional materials used. Harmonized and Non harmonized standards can often be used to substantiate testing specifications, such as biocompatibility and performance testing. Therefore, even you do not have access to a competitor technical documentation information in the public domain will help to large extend.
How can I verify EU MDR Clinical evaluation documents are correct?
We offer a free tool made in line with the latest MDR. Customers can browse the page and take a trial to find the GAPS.
Is Meddev 2.7.1 Rev 4, to be followed for Class I Devices?
Yes, its mandatory. No matter what the device risk class and what for it is used.