MDR Clinical Evaluation (MEDDEV 2.7/1 Rev 4)

Data gathered by the use of medical device on human beings is called Clinical Data. There are multiple ways to gather clinical information (clinical trials, literature search, clinical Follow Up, market surveillance etc.)

A detailed assessment and analysis of clinical data pertaining to a specific device in order to verify the clinical safety and performance is called Clinical Evaluation.

Medical Device EU Regulation 2017/745, Chapter VI annex 61 mandates for conducting Clinical Evaluation in order to confirm safety and performance based on intended use claimed by the manufacturer set out in Annex I.

The manufacturer has the responsibility to justify the level of clinical evidence necessary to demonstrate conformity with MDR 2017/745.

That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose, so manufacturers shall plan, conduct and document a Clinical Evaluation in accordance with this Article 61, Part A and Annex XIV.

MEDDEV 2.7/1 Rev 4 released by the European Commission on July 1, 2016 is a Guidance document. NOT A LEGAL BINDING DOCUMENT.

The new revision is slightly larger in content with 65 pages against 46 pages in the earlier version and more detailed with 12 chapters and 23 appendices.

MEDDEV 2.7/1 Rev 4 guidelines details how efficiently and correctly Clinical Evaluation to be conducted throughout the whole life-cycle of the medical device, regardless of the device’s risk classification to confirm MDR 2017/745.

MDR 2017/745, Article 61 details about Clinical Evaluation.

EU MDR 2017/745 substantially tightens the Clinical Evaluation requirements for equivalence justification compared even to MEDDEV 2.7/1 Rev 4 expectation.

Information on competitors clinical data, specification and other data is almost impossible which makes the level of MDR compliance makes things tougher.

MDR Article 61 paragraph 4 states; In the case of implantable devices and class III medical devices, clinical investigations shall be performed, except if..

• The device has been designed by modifications of a device already marketed by the same manufacturer.
• The modified device has been demonstrated equivalent by way of technical, biological and clinical characteristics with equivalent device.
• The data adequately demonstrate compliance with the relevant general safety and performance requirements.

For Class III devices notified body shall check that the Post Market Clinical Follow (PMCF Plan) is appropriate and includes post market studies to demonstrate the safety and performance of the device in the case no clinical investigation opted by the manufacturer.

MDR Article 61 paragraph 6 states; Clinical Investigations need not be performed if previously CE Certified and marketed in accordance with Directive 90/385/EEC or Directive 93/42/EEC with sufficient clinical data and devices such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product specific CS, where such CS is available.

MDR Article 61 paragraph 11; states class III implants PMCF report along with summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with relevant data.

MDR Article 61 paragraph 12; states clinical evaluation, its results and the clinical evidence derived from it shall be documented as Clinical Evaluation Report (CER) as referred to in Section 4 of Annex XIV, Clinical Evaluation Report shall be part of the Technical Documentation (Technical File) for each device covered in the scope as referred in MDR Annex II.

Major activities involved in MDR Clinical Documentation

As a manufacturer of the medical device following are the major process in complying MDR Article 61

• Clinical Evaluation Plan (CEP) in detail covering well-defined activities with proper procedure and records as part of demonstrating the clinical safety and performance. Scoping of the clinical evaluation is the first and the foremost step in CEP.
• Literature Search and Review The quality and quantity of literatures must sufficient to prove clinical evidence to guarantee the scientific validity of the conclusions. Different sources of clinical literature, a comprehensive search strategy in multiple databases must be followed.
• Clinical Evaluation Report (CER) A Clinical Evaluation Report shall be compiled to document the clinical evaluation and its output on a specified time schedule. ii. CER should contain enough information to be read and understood by an independent party like regulatory authority or notified body. CER should provide enough detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made, and all conclusions reached.
• Risk Analysis as per ISO 14971 If the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, then the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk.
• IFU warnings and contraindications
• Post Market Surveillance ( PMS) and or Periodic Safety Update Report (PSUR)
• Post Market Clinical Follow Up ( PMCF)
• Biological Evaluation & Pre-Clinical Studies
• Predicate Device / Equivalent Device analysis

Establishing Equivalence a MUST for completing CER as per MDR

MEDDEV 2.7/1 Rev. 4 requirements for demonstrating equivalence is more stringent as it is in MDR. Full demonstration of Clinical, Biological and Technical equivalence with respect to medical device characteristics must be performed during Medical Device Clinical Evaluation.

Some key points for manufacturers to consider.

As per latest MDR, for a Class III implantable and few Class IIb device manufactures must have a contract with the owner of the equivalent device for granting permission to access the technical documentation of the equivalent device by applicant ‘s Notified Body.

Due to this dilemma to have access to proprietary information of other company, the applicant will need to reconsider different routes for collecting clinical evidence such as Clinical Trials or Post Market Clinical Follow up.

While the MDR does not define parameters for determining equivalence. Guidance document MEDDEV 2.7/1 rev 4 has distinctly identified criteria for evaluation of an equivalent device to be used as clinical evidence. As a result, companies are currently facing the following types of issues from Notified Body review:

• Without serious evaluation addressing all technical, biological, and clinical aspects to claim equivlancy.
• Devices not CE Marked are considered as equivalent or similar device for comparison.
• The technology specification is spread across multiple devices.
• Inadequate justification about impact safety or performance characteristics with device in question and equivalent device.

MEDDEV 2.7/1 Rev 4 special emphasis on Evaluation & Directions

Medical Device manufacturers who are already certified or ready for CE Certification must reanalyze the way the CER is presented earlier to the Notified Bodies. Previously CERs were a significant part of the Technical File

• All Implantable devices and class III devices, the outcome of evaluation will become public.
• Technical File in particular CER section will be critically evaluated and assessed by the Notified Body.
• For Implantable Class IIb  and Class III devices, Notified Body may ask an expert panel the review of the report.
• MEDDEV recommendations are incorporated into the MDR in article 61 and annex XIV including requirements related to equivalent devices.

As per new MDR article 61 and MEDDEV 2.7/1 Rev 4 Clinical Evaluation should be a standalone document with all kind of clinical data evidence on the Medical Device in alignment with the intended claims, residual risks, etc., summarized into the Technical File or Design Dossier.

MDR Clinical Evaluation should also support all the information and materials manufacturer claims via IFU or user manual or any advertising materials where device’s claim is being made to ensure it is accurately evidenced.

The CER should also be thoroughly prepared with reference to any therapeutic alternatives, surgical practices, equivalent devices, in order to establish a solid State Of The Art, pre-requisite to any device development.

Completion of a CER when first conducting the Medical Device CE Marking conformity assessment process can help Manufacturers understand whether an investigation is much necessary or to identify any alternative way of gathering evidence supporting a claim or addressing a risk by way of additional preclinical tests, risk analysis, or even re-designing of the medical device.

Advantages of Outsourcing CER Documentation to us.

Our specialist writers will simplify and well organize the Clinical Evaluation ER for early stage NB approval or to safe guard CE Certificate Validity.

All must understand that Medical Device Clinical Evaluation is a recurring activity throughout product lifecycles as far as you are planning for CE Certification or holding a valid CE Certificate.

Companies must develop and maintain procedures readily available along with the report and supporting evidences which includes the complete product information, post market surveillance, risk management and equivalent device data.

Looking above the sheer scale of work load and with the monumental task of developing and reviewing documentation for their entire medical devices covered in each of the technical files / Design dossiers  by company employees are not ideal.

According to a recent report, 68% of medical device companies reports prepared and submitted in-house team are either rejected by the notified bodies or multiple major gaps are found in their CER's and supporting evidences.

When it comes to conduct of Clinical Evaluation, manufactures are highly recommended to appoint experienced consultants / clinical writers to make the process more efficient via the documentation done by trained external professionals.

The investment needed for the training of In-house team is much higher than hiring MedDeviceCorp team as Consultants / medical writing company.

For more information and if interested in taking our service, please write to us.