MDR Clinical Evaluation
MDR Clinical Evaluation referred in 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 receiving CE Marking in the EU, medical device manufacturers must demonstrate to the relevant authority that their device satisfies the safety and performance requirements; hence, the EU MDR requires device clinical evaluation. It is mandatory for all medical devices, regardless of the risk classification.
Task of updating MDR Clinical Evaluation Documents
In the new medical device regulation MDR 2017/745 all manufacturers have 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 clinical evaluation report to notified bodies for CE Certification.
It is understood from the enquires we receive every day across the Globe, 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, 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.
Here are a few challenges that we have heard from the medical device manufacturers
The clinical testing requirement for products earlier exempted, Interpretation of scientific Clinical Data, availability & readiness of Clinical evaluation report throughout the year,
Keeping track of annual safety updates and maintaining dynamic data records
Establishing state of the art (SOTA) with an extensive amount of supporting clinical data, the outcome of risk-benefit analysis, and results of applicable bench testing
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 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 is essential for 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!
EU MDR article 61 CER must present convincing interpretations to justify clinical safety and performance of the device with in-depth supporting documentary evidence. I3CGLOBAL will reduce significantly the loss of revenue from manpower and decreases time to market.
Frequently Asked Questions
To avoid clinical trials / investigation do we need to establish a Quality Agreement with the comparator device manufacturer?
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. Can I avoid doing Clinical investigation?
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.
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 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. Check right side link
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.
When to update MDR Clinical Evaluation Documents
Clinical Evaluation and safety check is a continuous process besides, (a) Change in device State of Art (b) Change in components (c) Annual Updates
Is Post Market Surveillance and Report part of the CER?
Yes, Post Market Surveillance is part of Clinical Evaluation for all devices, but PMSR is required only for Class 1 devices.