Medical Equipment: Import Controls
(asked on 24th January 2023) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help reduce regulatory barriers for companies and healthcare providers importing medical devices and equipment from the European Union.
The Medicines and Healthcare products Regulatory Agency (MHRA) are unable to intervene in issues relating to capacity in the EU system. However, the MHRA recognises that there is a need to increase Approved Body capacity to ensure the continued supply of imported medical devices and equipment to the UK market by reducing regulatory barriers for companies and healthcare providers importing said devices. The MHRA are engaging with, reviewing applications from and auditing a number of organisations who have applied to be designated as a UK Approved Body. The MHRA is taking a pragmatic approach to the designation of these Approved Bodies, balancing the need to establish an independent UK system against avoiding any unnecessary duplication
On the 25th October 2022, the MHRA announced that there will be a 12-month extension to the implementation of new UK Medical Device Regulations to accommodate for any disruption caused by the Great Britain’s departure from the European Union. Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. Following this, from July 2024 the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market. Manufacturers are also able to apply to the MHRA for an Exceptional Use Authorisation (EUA) which permits the supply of a medical device without a valid CE or UKCA mark in certain circumstances.
In addition to building Approved Body capacity and extending the implementation of the revised UK regulations, the MHRA is working, with industry partners and designated Approved Bodies, to assess what further actions can be taken to ensure ongoing supply of medical devices where manufacturers have been unable to secure ongoing certification.