Meddev 2.7.1 Rev 4. Clinical Evaluation

MEDDEV Clinical Evaluation (MDR) (2.7/1 Rev 4)

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 and MEDDEV Clinical Evaluation.

EU Medical Device Regulation 2017/745 substantially tightens the 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 thins tougher.

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

(a) the device has been designed by modifications of a device already marketed by the same manufacturer.

(b) the modified device has been demonstrated equivalent by way of technical, biological and clinical characteristics with equivalent device:

(c) 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 Up Plan (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 a 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 such 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 process of MDR Clinical Evaluation

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

MEDDEV Clinical Evaluation is considered as a tool to provide the Notified Bodies with complete overview of the continuous process to demonstrate safety and performance of the medical device. During the process, all data that could provide information on the Safety and Performance of the device is analyzed and assessed.

MEDDEV 2.7/1 Rev 4 Clinical Evaluation

MEDDEV Clinical Evaluation (MDR) 2.7.1 Rev 4

MDR 2017/745 has special emphasis on Evaluation and directions.

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

Medical Device manufactures who are already certified or planning for CE Certification must re-think the way the CER is presented earlier to the Notified Bodies. previously CERs were a significant part of Technical File, but as per new MDR Clinical Evaluation and MEDDEV 2.7.1 Rev 4 it should be a standalone document summarizing any kind of 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 be supporting any 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 regards 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 Medical Device Clinical Evaluation 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 writing CER, companies can make the process more efficient through the documentation done by trained external professionals. The investment needed for the training of In-house team is much higher than hiring a consulting /medical writing company.

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

Additional Resources

Clinical Evaluation Procedure

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