Ministry of Health

Department of Health and Social Care (UK)

Regulatory Authority

Medicines & Healthcare products Regulatory Agency (MHRA)

Medical Device Regulation

The Medical Devices Regulations 2002

UK Conformity Assessed Marking Process (effective Jan 2023)

Official Language

English

Classification

Class I, IIa, IIb and III

Registration Process

• 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

• Declaration of Conformity (DoC)
• Product Description
• Technical File
• Label, IFU and User Manual
• Letter of Authorization
• Clinical Studies Report
• CE Mark or UKCA mark
• Risk Management Plan
• Post-market surveillance
• General safety and performance requirements
• Product verification and validation
• Biocompatibility, Sterilization Information (if applicable)

Post-market Requirements

• Serious public health threat – 2 calendar days
• Death or unanticipated serious deterioration in state of health – 10 calendar days
• Others – 30 calendar days

Guidance for manufacturers on vigilance

Applicable QMS

Essential Principles Requirements – Annex I, The Medical Device Regulations 2002

ISO 13485

Registration Timeline

2-4 weeks

Authorized Representative

Yes. UK Responsible Person (UKRP)

License Validity

License expires with the CE mark or UKCA mark expiry.

Special Notes

Distributors and Suppliers are not required to register with MHRA