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Clinical Evaluation as per MEDDEV 2.7/1 Revision 4

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 is one of the most challenging requirements in the new Medical Device Regulation (MDR) and IVD Regulation (IVDR) to perform a clinical evaluation throughout the whole life-cycle of the medical device, regardless of the device’s risk classification.

In the new MDR & IVDR regulations, clinical evaluation is considered an essential part of the Technical File / Design Dossier and absence of Clinical Evaluation may lead to CE Mark Certificate suspension. Already Notified Bodies are expecting up to date clinical evaluation reports (CERs) with extensive data review according to the applicable guidelines and performed by qualified Clinical Evaluators.


When to perform a Clinical Evaluation?


Clinical Evaluation must be conducted throughout the life cycle of a medical device in question. This is a never-ending process and substantial supporting records should be maintained by the manufacturer.

The Clinical Evaluation must be updated on annual basis or as decided by the manufacturer based on the risk factors associated with the use of the device in question.



Clinical Evaluation must focus on:

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

The Clinical Evaluation Report (CER) is considered a tool to provide Notified Bodies with a complete overview of the continuous clinical evidence of the safety and performance of the medical device. During the Clinical Evaluation Process, all data that could provide information on the Clinical Safety and Performance of the device is analyzed and assessed.


Clinical Evaluation and Medical Device Regulation (MDR) 2017/745

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

As per MDR

  • All Implantable devices and class III devices, the outcome of clinical evaluation will become public.
  • Notified Bodies' assessments of manufactures Technical File in particular Clnical Evaluation Report (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 Clinical Evaluation
  • MEDDEV recommendations are incorporated into the MDR in article 61 and annex XIV including requirements related to equivalent devices.

Resources

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 Clinical Evaluation guide for manufactures and NB’s

List of Harmonized Standards - Official Journal

 

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