21 September 2018
Lord O’Shaughnessy, the Parliamentary Under Secretary of State for Health, whose portfolio covers the medical devices sector, has responded to the BDIA’s recent letter to him voicing the industry’s concerns over the slow progress in developing the infrastructure associated with the implementation of the Medical Devices Regulation. The Minister comments that the UK continues to work with EU partners to implement the new regulation and , covering Brexit, states that it is unlikely that the UK will leave the EU without an agreement. Specifically referring to the designation of Notified Bodies, Lord O’Shaughnessy states that, “Applications have been received from UK Notified Bodies and are being prioritised, with the first ever joint assessment under the MDR taking place within the UK”. Assuming the necessary agreements are made under Brexit negotiations, we are reassured that the Government recognises this issue and is working on solutions. We continue our close engagement with the MHRA on MDR and Notified Body issues.
Read the full letter from Lord O’Shaughnessy here.