MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom government agency responsible for regulating all medicines and medical devices in the UK. Following Brexit, the MHRA operates as an independent regulatory authority, establishing its own framework for medical device regulation distinct from the European Union's system.

Role and responsibilities:

The MHRA's mission is to enhance and safeguard the health of the public by:
- Regulating medicines, medical devices, and blood components for transfusion
- Ensuring products meet appropriate standards of safety, quality, and efficacy
- Operating the Yellow Card scheme for reporting adverse incidents
- Conducting market surveillance and enforcement
- Issuing safety alerts and recalls
- Licensing manufacturers and distributors
- Providing scientific and regulatory guidance to industry
- Participating in international regulatory collaboration

Post-Brexit regulatory framework:

Following the UK's exit from the European Union on January 31, 2020, and the end of the transition period on December 31, 2020, the MHRA established independent UK-specific regulations:

UK Medical Devices Regulations 2002 (as amended):
- Retained EU law adapted for UK jurisdiction
- Three separate regulatory routes: Great Britain (England, Scotland, Wales), Northern Ireland, and international
- Northern Ireland continues to follow EU MDR/IVDR under Northern Ireland Protocol

UKCA (UK Conformity Assessed) marking:

The UKCA marking is the UK's product marking requirement for medical devices placed on the Great Britain market:

UKCA marking requirements:
- Mandatory for medical devices placed on GB market (England, Scotland, Wales)
- Replaced CE marking for the GB market
- Demonstrates compliance with UK regulations
- Not recognized in EU/EEA (CE marking still required for EU)

UKCA transition periods:
- Initially devices with valid CE marks were accepted
- Extended transition deadlines have been implemented
- Full UKCA requirements vary by device type and certification pathway
- Current guidance: CE marking accepted until July 1, 2025 for most devices
- After transition, UKCA marking mandatory

Northern Ireland:
- Continues to recognize CE marking under EU MDR/IVDR
- Unique status under Northern Ireland Protocol
- UKNI marking for devices manufactured in Northern Ireland for GB market

Medical device classification:

The MHRA uses a risk-based classification system aligned with international standards:

Class I - Low risk:
- Examples: Bandages, crutches, examination gloves
- Manufacturer self-certification
- Lower regulatory burden

Class IIa - Low-medium risk:
- Examples: Contact lenses, hearing aids, ultrasound devices
- Approved Body assessment for certain aspects
- Declaration of conformity

Class IIb - Medium-high risk:
- Examples: Ventilators, X-ray machines, surgical lasers
- Approved Body conformity assessment required
- More extensive technical documentation

Class III - High risk:
- Examples: Heart valves, drug-eluting stents, breast implants
- Highest regulatory scrutiny
- Full Approved Body assessment including design dossier

UK Approved Bodies:

Post-Brexit, the MHRA designates UK Approved Bodies (formerly Notified Bodies) to conduct conformity assessments:
- Must be established and operate in the UK
- Designated by MHRA to perform conformity assessment
- Subject to MHRA oversight and surveillance
- Currently limited number of UK Approved Bodies compared to EU
- Manufacturers may face capacity constraints

Registration and market access:

MHRA device registration:
- All medical devices must be registered with MHRA before being placed on GB market
- Online registration through MHRA portal
- Includes manufacturer and device information
- Updated registration system aligned with post-Brexit framework

UK Responsible Person:
- Non-UK manufacturers must appoint UK Responsible Person
- Acts as liaison with MHRA
- Ensures compliance with UK regulations
- Maintains technical documentation in UK
- Similar role to EU Authorized Representative

Technical documentation:

Manufacturers must maintain comprehensive technical documentation including:
- Device description and intended use
- Design and manufacturing information
- Risk management documentation (ISO 14971)
- Clinical evaluation reports
- Instructions for use and labeling
- Conformity assessment certificates
- Post-market surveillance plan

Relationship with EU MDR:

Divergence from EU framework:
- UK regulations initially mirrored EU MDR but are diverging
- MHRA may introduce UK-specific requirements
- Separate conformity assessments may be needed (UKCA vs CE)
- Different timelines for implementation
- Manufacturers must navigate dual compliance for UK and EU markets

Mutual recognition challenges:
- EU does not recognize UKCA marking
- CE marking certificates from UK Approved Bodies not valid in EU post-Brexit
- Manufacturers may need both UK and EU conformity assessment
- Increased regulatory burden for companies serving both markets

Post-market surveillance:

Vigilance reporting:
- Mandatory reporting of adverse incidents and field safety corrective actions
- Defined timelines based on severity (immediate to 30 days)
- Online reporting through MHRA systems
- Coordination with EU EUDAMED for Northern Ireland devices

Yellow Card Scheme:
- Public and healthcare professional reporting system for adverse events
- Covers medicines, medical devices, and vaccines
- Accessible online and via mobile app
- Important source of real-world safety data

Market surveillance:
- MHRA monitors devices on UK market
- Inspections of manufacturers and distributors
- Investigation of non-compliant products
- Power to require recalls or safety actions
- Enforcement actions including penalties

UKCA marking requirements:

Conformity assessment routes:

Route 1: UK Approved Body:
- Assessment by MHRA-designated UK Approved Body
- UKCA marking affixed
- Valid only for GB market

Route 2: EU Notified Body (transitional):
- CE marking from EU Notified Body
- Accepted during transition period
- Must appoint UK Responsible Person
- Limited to transition deadline

Route 3: Self-declaration (Class I):
- Manufacturer self-certifies compliance
- Technical documentation maintained
- UKCA marking affixed

Labeling requirements:
- UKCA marking must be visible, legible, and indelible
- Accompanied by UK Approved Body identification number (if applicable)
- UK address of manufacturer or UK Responsible Person
- Instructions for use in English
- Compliance with UK-specific labeling regulations

Unique Device Identification (UDI):

The MHRA is implementing UDI requirements aligned with international standards:
- Phased implementation by device risk class
- Registration in UK medical device database
- UDI carriers on device labels and packaging
- Enhances traceability and post-market surveillance

Clinical evidence requirements:

Clinical evaluation and clinical investigations follow principles similar to EU MDR but under MHRA oversight:
- Clinical evaluation reports required demonstrating safety and performance
- Clinical investigations conducted in UK subject to MHRA and Research Ethics Committee approval
- Good Clinical Practice (GCP) compliance
- Informed consent and ethical considerations

Software and AI/ML devices:

MHRA has issued specific guidance for Software as a Medical Device (SaMD) and AI/ML-enabled devices:
- Risk classification considerations for software
- Cybersecurity requirements
- Algorithm transparency and validation
- Post-market monitoring for adaptive algorithms
- Alignment with IMDRF SaMD framework

MHRA innovation support:

Innovation Office:
- Supports developers of innovative products
- Regulatory advice and guidance
- Accelerated assessment pathways
- Early engagement opportunities

Early Access to Medicines Scheme (EAMS):
- Pathway for promising medicines and devices
- Allows earlier patient access for life-threatening conditions
- Conditional approval framework

Regulatory flexibility:
- MHRA can implement risk-proportionate approaches
- Potential for streamlined pathways post-Brexit
- Adaptive licensing frameworks

International collaboration:

Despite Brexit, MHRA maintains international cooperation:
- Member of International Medical Device Regulators Forum (IMDRF)
- Collaboration with FDA, TGA, Health Canada, and other authorities
- Participation in International Council for Harmonisation (ICH)
- Mutual recognition agreements under negotiation

Brexit transition support:

The MHRA has provided extensive guidance for industry:
- Detailed guidance documents on UKCA marking transition
- Webinars and Q&A sessions
- Regulatory updates and newsletters
- Online resources and checklists
- Stakeholder engagement

Key differences from EU MDR:

• Separate conformity assessment required for UK market
• Different Approved Body landscape (fewer UK Approved Bodies)
• UKCA marking instead of CE marking
• UK Responsible Person instead of EU Authorized Representative
• Potential for divergent regulatory requirements over time
• Different timelines and transition periods
• Separate registration databases

Fees:
- MHRA charges fees for device registration
- Approved Body fees for conformity assessment
- Clinical investigation application fees
- Reduced fees for small/medium enterprises in some cases

Manufacturers operating in both UK and EU markets must carefully navigate dual regulatory pathways, often requiring separate conformity assessments, registrations, and ongoing compliance activities. The MHRA continues to evolve its post-Brexit regulatory framework, balancing UK-specific innovation with international alignment.