Research use only products

Devices intended specifically for 'research use only' are not usually considered to come within the remit of the directive.

This means that the product must have no medical intended purpose, no medical objective and not be intended for performance evaluation purposes. Clarification of the definitions of 'performance evaluation' and 'research use only' are contained within the European Commission's guidance document MEDDEV 2.14/2. Products intended for research use only should be clearly labelled as such.


Page last modified: 13 May 2009