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United Kingdom Medical Device Registration

Medicines and Healthcare products Regulatory Agency (MHRA) approval timelines and requirements

0.5-1 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

UK Responsible Person

United Kingdom Medical Device Registration Overview

United Kingdom medical device registration through MHRA typically takes 0.5-1 months for Class I devices. The official MHRA target is 0.5-1 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.United Kingdom uses a 4-class (I, IIa, IIb, III) risk-based classification system. Foreign manufacturers must appoint a UK Responsible Person to register devices in United Kingdom. Registration is valid for 5 years.

Registration Timeline by Device Class

United Kingdom uses a 4-class (I, IIa, IIb, III) risk-based classification system.

Class I

Self-declaration or CE Mark

Low Risk

Official

0.5-1 months

Realistic

0.5-1 months

With Prior Approval

2-3 weeks

Accelerated with: EU CE Mark (accepted until 2028+)

• CE mark provides immediate access during transition

Class IIa

UKCA (UK Approved Body) or CE Mark

Medium Risk

Official

3-6 months

Realistic

3-6 months

With Prior Approval

0.5-1 months

Accelerated with: EU CE Mark (accepted until Jun 2028)

• UKCA takes 3-6 months, CE mark weeks

GMP/QMS Required

Class IIb

UKCA (UK Approved Body) or CE Mark

High Risk

Official

4-8 months

Realistic

4-8 months

With Prior Approval

0.5-1 months

Accelerated with: EU CE Mark (accepted until Jun 2028 or Dec 2027 for implantables)

• CE mark significantly faster during transition

GMP/QMS Required

Class III

UKCA (UK Approved Body) or CE Mark

Highest Risk

Official

6-12 months

Realistic

6-12 months

With Prior Approval

0.5-1 months

Accelerated with: EU CE Mark (accepted until Dec 2027 for Class III)

• CE mark provides immediate access until 2027

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

CE Mark Recognition (Transition)

EU CE marks accepted during transition period

Immediate market access

Eligibility: Class III & IIb implantable: until Dec 2027, Other classes: until Jun 2028, MDR/IVDR compliant: until Jun 2030

International Reliance (Proposed)

Expedited pathway for FDA, TGA, Health Canada approved devices

Under consultation for 2026

Eligibility: Under development

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your United Kingdom registration.

EU CE Mark

Full recognition during transition (until 2027-2030)

Months → Weeks

FDA 510(k)

Under consultation for future reliance

Future TBD

Key Requirements

UK Responsible Person (for non-UK manufacturers)
UKCA marking or CE marking (during transition)
UK Approved Body certification (for UKCA)
MHRA registration

Registration Validity:

5 years

Registration Process Flowchart

United Kingdom Medical Device Registration Process

Step-by-step MHRA registration process. Total estimated timeline: 0.5-1 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MHRA. Appoint a UK Responsible Person.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MHRA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MHRA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

0.5-1 months

In-depth technical assessment of device safety and performance. MHRA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MHRA issues United Kingdom market authorization certificate.

Summary: The United Kingdom medical device registration process through Medicines and Healthcare products Regulatory Agency (MHRA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

MHRA Regulation News Government Registration Fees

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🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇧🇷 BrazilANVISA 🇨🇦 CanadaHealth Canada

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.