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.
- 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.