EU reference laboratories
For specific medical devices or group of devices, the European Commission designate one or more European Union reference laboratories. The most important responsibilities are:
- Verification of the claimed medical device performance of class D devices
- Performance of tests on samples of class D devices or batches of class D devices
- Provision of scientific and technical assistance to the EU Commission, the MDCG, the Member States and Notifies Bodies
More details as well as all responsibilities of the EU reference laboratories are set out in article 100, IVDR
