MEDDEV 2.7/1 revision 4 – Changes to Clinical Evaluation Reports for Medical Devices in Europe

The latest edition of MEDDEV 2.7/1 (revision 4) was released in June 2016 replacing the December 2009 version.  The changes center on adding more detailed and expansive requirements for clinical data.  While MEDDEV is a guidance document, companies should be prepared to conform to its updated contents as soon as possible.

Changes include:

  • Further definition of time requirements related to submitting a clinical evaluation report (CER)
  • Further definition of qualifications required for members of the person or team writing the CER
  • Changes to the review protocols for literature and further definition regarding the types of literature reviews that are deemed acceptable
  • Defining of what “state of the art” entails
  • Equivalence clarified to allow for multiple devices, but that each device must meet the required equivalence characteristics
  • More detail added to expectations for demonstration of equivalence
  • Added requirements for details on equivalent devices, equivalence can only be claimed for design modifications of manufacturer’s own CE marked devices or where a contract is in place with the other manufacturer allowing full access to the data on an ongoing basis
  • Further definition of clinical evidence and the need for clinical investigations for implantable, high risk devices, and/or new and unproven devices
  • Further clarification of requirements for acceptable risk/benefit to patient
  • Further requirements for notified body assessments

There are no changes to the principles that state a manufacturer must use clinical data to demonstrate compliance with relevant essential requirements.  Data must be based on pre-market investigations done with the device, in addition to other investigations conducted for devices and data from post-market surveillance and vigilance activities.  Clinical data still must be collected, appraised, and analyzed.