LRQA’s role as an EU Medical Devices Notified Body

LRQA’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, LRQA will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) so that LRQA remains as an EU recognized Notified Body for Medical Devices post the UK leaving the EU.

LRQA fully anticipates remaining a long term major EU Medical Device Notified Body and has developed a number of potential options of how this will be achieved dependent on the final agreements made between the EU and UK:

  • There are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies. For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.
  • LRQA has a strong local presence in many EU countries through local legal entities and, if it becomes necessary, would be able to transfer its Notified Body status to one of these operations to continue to provide services to clients worldwide.

All management systems training and accredited certification remains unaffected by the outcome of the referendum.

Naturally, we will continue to provide updates as events unfold.

Contact us to learn more about EU Medical Devices Regulation (MDR)