Mutual Recognition Agreements

A number of agreements have been negotiated between the EU and third party countries which allow bodies based in the third countries to perform assessments against the EU requirements and vice versa.

Medical devices have been incorporated in many of the agreements, including those with Canada, USA, Australia, New Zealand and Switzerland.

All such approved bodies based in the UK are Notified Bodies under the EU requirements and manufacturers, in the first instance, should contact their own Notified  Body. Further information and details of relevant agreements can be found on the EU Commission website.


Page last modified: 10 August 2005