MHRA Publishes a Statement of Policy for the International Recognition of Medical Devices

On 21 May 2024, the MHRA published a statement of policy for the international recognition of medical devices. It is their intention to recognise, Australia – Therapeutic Drug Administration (TGA), Canada – Health Canada, European Union – National competent authorities in the member states of the EU/European Economic Area (EEA) and United States of America – Food and Drug Administration (FDA). The MHRA is in discussion with Japan – Pharmaceuticals and Medical Devices Agency (PMDA) and will continue to review the list of other countries.

It is intended that the final version would be integral with the future core regulations that, at this time, are set to commence in 2025.

NHS Supply Chain welcomes the proposal in the hope that it will help to relieve the resilience issues we are experiencing in some areas of the medical device industry. We have a dedicated regulatory governance team that diligently check UKCA and EU conformity documentation along with quality certification.

The team is equipped to deal with variations in the requirements for international bodies and will be preparing to increase the scope to cover the requirements of the comparable regulator countries (CRCs). In addition, the proposed certificate of international recognition, that will grant devices access to the market in Great Britain, will be verified by the team.