New MEDDEV Document on the Clinical Evaluation of Medical Devices

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

To put the EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC" has been newly published. Comprising 65 pages, the document is very extensive and describes requirements for the clinical evaluations of medical devices in Europe.

The new version (Version 4) clarifies some aspects but has also become tighter compared to the previous seven-year-old version which comprised only 45 pages and was thus slimmer. The fact is that the revision is considerably more comprehensive than the previous version. Moreover, examples and suggestions have been added, which - among other things - is reflected in many appendices. The use of "must", "shall", and "have to" relating to the Directives is very interesting as well as the fact that the term "could" is used for own MEDDEV topics in the document (not based on the Directives).

What's new?

• High requirements are set on those who want to perform a clinical evaluation. Here, concrete specifications are described and the concept of team is already mentioned as a possibility to be able to meet all the preconditions.
• Much importance is attached to literature searching in databases (preferably in the European ones).
• The topic "demonstration of equivalence" is now extensively present in the document. 
• In future, more emphasis will be put on updating the clinical evaluation. Examples of when an update is necessary are mentioned. Depending on the requirements, cycles or periodic updates are also indicated (annually or every 2 to 5 years).

In vitro diagnostic devices are expressly excluded from the scope of the document.

For more detailed information please see the MEDDEV Guidelines - Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC.