Clinical Evaluation chapter VI of the new Medical Device Regulation 2017/745, article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.
A detailed assessment of clinical data with sufficient clinical evidence pertaining to side-effects and acceptability of the benefit-risk-ratio to verify clinical safety and performance is called Clinical Evaluation. (refer to MEDDEV Clinical Evaluation Procedure)
Before obtaining CE Marking in the EU, medical device manufacturers must prove to the competent authority that their device meets the safety and performance standards and hence, the EU MDR necessitates the evaluation of devices. It is required for all medical devices regardless of their classification
Medical Device Clinical Evaluation
The new Medical Device Regulation MDR 2017/745 all manufacturers has to face the monumental task of updating CER documentation for their entire product portfolio. This task must be completed before they provide technical documentation which includes the CER to Notified Bodies for CE Certification.
It is understood from the enquires we receive every day across the Globe, 60% of device manufactures 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, CER 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.
Medical Device Clinical Evaluation Consultants must need cross-platform expertise and in-depth knowledge in MDR Article 61 & MEDDEV 2.7/1 Rev.4 (Download Guidelines)
Medical Device Manufacturers Challenges
Here are a few challenges that we have heard from the medical device manufacturers
New MDR Classification
The clinical testing requirement for products earlier exempted, Interpretation of scientific Clinical Data, availability & readiness of CER throughout the year
PMCF & PSUR Compliance Monitoring
Keeping track of annual safety updates and maintaining dynamic data records
Clinical Evaluation Report
Clinical Evaluation Report is not a new requirement for high-risk device manufacturers but after the high-profile scandals a few years back questioned the adequacy of existing criteria, followed by the EU Commission came up with new Medical Device Regulation (MDR) introduced in May 2017 tightened requirements for CERs.
To achieve and maintain CE Certification for a medical device as per MDR 2017/745 and authorization for sale in EU territory, every class Is, Im, Ir, IIa, IIb, III medical device must receive technical documentation approval along with CER approval from Notified Body.
We assist our clients by preparing CER in line with article 61 and Annex XIV of MDR and MEDDEV 2.7/1 Rev 4
Clinical Evaluation Report Writer in short CER Writer must be from biology or any science educational background with expertise in Medical Device regulatory, development, usage on patients or design technology.
Clinical Evaluation - MDR Vs MDD
The requirement to perform Evaluation found in part I of Annex X of 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 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.
Clinical Evaluation Consultants & Writers
Any organization unity brings success!! The regulatory compliance team working with CER Consultants (outsourced experts) helps to increase the overall quality of CER due to the extensive experience and skills of external consultants 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 Consultants & Writers’ 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 your time, money, and finally no assurance of success.
The coordination between consultants and client team members are essential for the successful completion. Read more about the responsibilities of each team.
Clinical Evaluation Plan
Manufactures those require to demonstrate the safety and performance of a medical device with the help of clinical data, Clinical team must plan a sound method for identification, collection, and analysis of the clinical data with the proper time schedule. Clinical Evaluation Plan (CEP) must include the scope of the CE in relation to device intended use, indication, state of art, etc.
Brainstorming Interactive Ideas on MDR Article 61!
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We solve every obstacle in the path of MDR Article 61 and Meddev 2.7/1 Rev. 4 compliance. End-to-end solutions for small, medium and large scale medical device manufacturers
Frequently Asked Questions
Do all manufactures need to have Quality Agreement with manufacturer of the comparative device to avoid performing clinical trials?
Article 61 paragraphs 4 and 5 in MDR states “In the case of implantable devices and class III devices, clinical investigations shall be performed, it doesn’t explicitly state that it only applies to all class of devices. Therefore, it will ultimately be up to the respective notified body to determine the based on scope of manufactures class III tech files. Generally notified body accept technical documentation if PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
My device is equivalent to an already marketed device manufactured by third party. Can I avoid doing Clinical investigation and their by Clinical Evaluation?
If both manufactures agreed to have access to each others technical documentation throughout the ongoing MDR review process and the original clinical evaluation has been performed in compliance with the requirements of new MDR.
Who is a Consultant? Can the consultant be an “Evaluator”?
Consultant 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 independly make final judgements about the data collected.
Do I need to update my CER documents to MDR Article 61, even I comply with MEDDEV 2.7/1 Rev 4?
It is advisable to access the present documentation as more than 8 places change is inevitable.
Can I modify MEDDEV 2.7/1 Rev 3 documents to MDR Article 61 directly.
MEDDEV 2.7/1 Rev 3 & 4 is only a guidance document. Manufactures must complete documentation in line with MDR Article 61 for easy NB approval.
I don't have access to a competitor's technical documentation or their own clinical data. how can i demonstrate equivalence as per article 61 of MDR?
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 Medical Device 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 it mandatory for Class I Devices also?
Yes, No matter what the device and what for it is used.
When to update CER documents.
(a) Change in device State of Art (b) Change in components (c) Annual Updates
Is Post Market Surveillance is part of the CER documentation?
Yes, Post Market Surveillance, Post Market Clinical Follow Up and Periodic Safety Update Report are part of new MDR and essential for CER documentation.