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United Kingdom

Medical Device Registration in United Kingdom

Ministry of Health

Department of Health and Social Care (UK)

Regulatory Authority

Medicines & Healthcare products Regulatory Agency (MHRA)

Medical Device Regulation UK

The Medical Devices Regulations 2002

UK Conformity Assessed Marking Process (effective Jan 2023)

Official Language

English

Medical Device Classification

Class I, IIa, IIb and III medical devices 

Medical Device Registration in United Kingdom

  • Determine the device classification
  • Appoint an Authorized Representative – UK Responsible Person (UKRP)
  • Until July 2023, the manufacturer will follow a regulatory pathway as per EU MDR 2017/745. The medical device should possess an EU CE Mark and submit Technical File to register with MHRA and market the device in the UK.
  • After July 2023, the medical device will be subjected to the UK Conformity Assessed (UKCA) marking process to continue marketing the device in the UK (England, Wales and Scotland).
  • UKCA Mark Assessment Routes
  • Class I: Product must comply with requirements of UK MDR 2002. The manufacturer prepares a Declaration of Conformity. For Sterility or Metrology Class I devices, an Approved Body (within the UK) must be appointed for conformity assessment.
  • Class IIa, IIb and III: Appoint an Authorized Body (within the UK) to carry out the conformity assessment. Once approved by Authorized Body, affix the UKCA mark, prepare a Declaration of Conformity and register the product with MHRA. The medical device can now be marketed in the UK (England, Wales and Scotland)

Documents Required

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Label, IFU and User Manual

Post-market Requirements

Serious public health threats – 2 day

Death or serious health deterioration – 10 days

Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I: 4-6 weeks

Others: Based on Notified Body timeline

Authorized Representative

Yes

License Validity

5 years

Special Notes

IFU and label of medical devices must be available in Hungarian.

Want to know more about this registration process?