Meddev 2.7.1 Rev 4. Clinical Evaluation

Clinical Evaluation as per MEDDEV 2.7/1 Rev 4.

Clinical Evaluation as per New MEDDEV 2.7/1 Rev.4 released by the European Commission on July 1, 2016. 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.

Mostly, MEDDEV 2.7/1 Rev 4 guidelines is one of the most challenging requirements in the new Medical Device Regulation (MDR) and IVD Regulation (IVDR) and should be performed throughout the whole life-cycle of the medical device, regardless of the device’s risk classification.

In the new MDR & IVDR regulations, it is considered as an essential part of the technical documentation (Technical File / Design Dossier) and absence or improperly arranged or incompletely filled requirements the requirements may lead to suspension of CE Mark Certificate or becomes major non-conformity.

Already Notified Bodies are expecting up-to-date CERs with extensive data review according to the applicable guidelines and performed by qualified Clinical Evaluators.

When to perform a Clinical Evaluation?

It must be conducted throughout the life cycle of medical device(s) covered in the technical file or design dossier. It is a never-ending process and substantial supporting records should be maintained by the manufacturer.
The CER must be updated on annual basis or as decided by the manufacturer based on the risk factors associated with the use of the device covered in the respective Technical File / Design dossier.

While performing what all must be the major focus areas?

  • Residual Risk as per ISO 14971,
  • IFU warnings and Contraindications,
  • Post Market Surveillance ( PMS) & Post Market Clinical Follow Up ( PMCF),
  • Pre human trials if required,
  • Data from an a predicate / equivalent device,

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.

clinical evaluation

Clinical Evaluation & Medical Device Regulation 2017/745

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 rethink the way the CER is presented earlier to the Notified Bodies, as earlier the CERs were a significant part of Technical File or Design Dossier. But now following as per EU MDR as well as MEDDEV 2.7/1 revision 4 (June 2016), the Report should now be looked as 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. The CER 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.

Routes of Clinical Evaluation and Data generation.

1. Literature Route:

Evaluation of your medical device based on comparable data of approved medical devices, and requires scientific peer-reviewed literature evidence on Safety & Efficacy. 

2. Clinical Study Route:

Novel devices, novel materials, novel technology, or missing literature on medical devices then studies conducted after getting approval of local Ethics-Committees.

Outsource CER Documentation to I 3 CONSULTING . Our specialist writers will simplify and well organize the CER for early stage NB approval or to safe guard CE Certificate Validity?

All must understand that 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

  • Frequently Asked Questions
  • Buy Meddev 2.7/1 Rev 4 updated Procedure, Plan and Important templets.
  • Periodic Safety Update Reports (PSUR).
  • Cost of Outsourcing Documentation as per MEDDEV 2.7/1 Rev 4.
  • CER GAP Analysis.
  • EU MDR CER Checklist.
  • Post Market Clinical Follow Up (PMCF).
  • Post Market Surveillance (PMS).
  • Importance of Annual CER Updates.
  • Download an useful article in PDF Format.
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

  • Council Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices.

  • MEDDEV 2.7/1 revision 4 guidelines for manufacturers and NB’s.

  • List of Harmonized Standards - Official Journal.

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