MHRA International Recognition for Medical Devices

The MHRA has issued a statement describing the draft policy detailing the intention of the UK to proceed with acceptance of alternative routes to markets utilizing approvals from other countries and Medical Device Single Audit Program (MDSAP) certificates, in addition to the current UK conformity assessed marking process (UKCA).

Currently the UK recognizes CE certification and approvals completed by the European Union (EU) until 30 June 2030. The proposed framework for additional international recognition for medical device applications would include Australia (TGA), Canada (Health Canada), the European Union (EU)/European Economic Area (EEA), and the USA (FDA).  In addition, there is ongoing discussions with the PMDA from Japan.

Note: It depends on device type, class, and prior approval. 

Manufacturers still have the option to use the UKCA marking to place devices on the market. 

The proposed framework would grant medical device access to the UK market without the requirement of the UKCA marking or UKCA certification and instead would grant access by providing a certificate of international recognition. The MHRA hopes this policy will allow the UK to remain attractive for medical technology manufacturers and facilitate faster approvals and access to medical devices for patients. 

There is still a requirement for a UK responsible person (possibly via over-labeling), and this proposed policy is a draft with a final version expected to come into force in 2025.  

You can read the full proposed framework here. 

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If you have any questions about this proposed framework, or how it can affect your medical device, please contact us so we can help you. 

Learn how MedEnvoy can assist you:

• • UK Responsible Person
  • UK Regulatory Importer
  • Consulting Services