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.
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..
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.
As a manufacturer of the medical device following are the major process in complying MDR Article 61
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
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.
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 I 3 CONSULTING team as Consultants / medical writing company.
For more information and if interested in taking our service, please write to us.