UK MHRA Medical Device
Registration &
UK Responsible Person (UKRP)
Your Partner for UK Market Access
Authorised UK Representative
Acting as your UK Responsible Person
MHRA Recognition & Compliance
Recognition on MHRA Public Register
UKCA Marking Support
Technical documentation & conformity route
Vigilance & Reporting
Incident reporting & vigilance system
Regulatory Expertise
Deep domain knowledge across device classes
End-to-End UK Support
From strategy to post-market compliance
Our UK Regulatory Services
1. UKCA Marking & MHRA Registration
- •Determine conformity assessment route (Annex II UK MDR 2002)
- •UKCA marking strategy & documentation support
- •MHRA registration for GB market
2. UK Responsible Person (UKRP) Services
- •Act as your UK Responsible Person
- •UK based point of contact for MHRA & authorities
- •Obligations under UK MDR 2002 Regulation 40
3. Technical Documentation Review & Gap Assessment
- •UK MDR Annex II compliance review
- •GSPR mapping & evidence assessment
- •Labeling, IFU & UDI alignment
4. Vigilance & Incident Reporting
- •Incident reporting to MHRA (Report of incident)
- •Trend reporting
- •Field Safety Corrective Actions (FSCAs)
5. Post-Market Compliance & Obligations
- •PMS plan & PMS report support
- •PSUR support (where applicable)
- •Record retention & data protection
6. Change Control & Lifecycle Support
- •Change impact assessment
- •Determine need for new submission to MHRA
- •Ongoing lifecycle compliance
7. EUDAMED & UDI Support
- •UDI-DI submission in EUDAMED (when applicable)
- •Actor registration support
- •Data accuracy & consistency
8. Manufacturing & Import Compliance
- •Sterilization, packaging & labeling compliance
- •Importer obligations
- •Supply chain documentation review
9. Software & Cybersecurity Compliance
- •Software as a Medical Device (SaMD) support
- •IEC 62304 alignment
- •Cybersecurity risk management support
10. Combination Products (Article 117) Support
- •Article 117 route assessment
- •GSPR & technical documentation support
- •Notified Body Opinion readiness
Our UK Regulatory Process
Regulatory Strategy & Route Assessment
UKRP Engagement (Where Required)
Technical Documentation & Compliance Review
UKCA Marking & MHRA Registration
Post-Market Compliance & Vigilance
Lifecycle Maintenance & Change Management
Why Choose NKB Regovanta for the UK?
Benefits of Our UKRP Services
Recognition on MHRA public register
Strengthen your market access readiness
Ensure compliance with Regulation 40 obligations
Reduce regulatory risk & delays
Ongoing support for regulatory changes
Certificate Compliance Management
About UK Market Access
Since Brexit, the UK has its own regulatory framework for medical devices – UK MDR 2002. Manufacturers must comply with UKCA marking requirements and, for many cases, appoint a UK Responsible Person (UKRP) to act as their local representative and regulatory contact.
Who Needs a UKRP?
You need a UKRP if you:
- Are not established in Great Britain
- Place medical devices on the GB market
- Need a local representative to meet Regulation 40 obligations
- Need support with MHRA communications and vigilance reporting
Who We Work With
Device Classes We Support
Including Custom-Made & Implantable Devices
The Regulatory Questions We Resolve First
UK market access is a regulatory decision pathway—not an administrative registration exercise. Before touching an application form, we address the critical structural questions that govern your product:
Is the product a medical device, IVD, active implantable device, accessory, system/procedure pack or another regulated product?
Will the product be placed on the Great Britain market, Northern Ireland market, or both?
What classification and conformity-assessment route applies?
Can the device rely on a currently accepted CE-marked route in Great Britain, or is a UKCA strategy appropriate?
Is a UK Responsible Person required and what regulatory records must be maintained?
What data must be registered with the MHRA before placement on the Great Britain market?
What technical, clinical/performance, testing, labeling and post-market evidence supports the route?
What obligations continue after registration, including PMS, vigilance, FSCA and change control?
Great Britain — England, Wales and Scotland
For Great Britain, medical devices and IVDs are regulated under the UK Medical Devices Regulations 2002, as amended. All medical devices, IVDs, custom-made devices and systems or procedure packs that fall within applicable registration requirements must be registered with the MHRA before placement on the Great Britain market.
A manufacturer established outside the UK must appoint a single UK Responsible Person for its devices placed on the Great Britain market. The UKRP acts on the manufacturer’s behalf for specified regulatory tasks, including MHRA registration and cooperation with the authority.
Our Great Britain Pathway Assessment Covers:
- • Product qualification and device type
- • Classification under the applicable UK framework
- • CE-recognition versus UKCA route
- • Conformity-assessment requirements
- • UK Approved Body involvement where applicable
- • UKRP appointment and mandate
- • MHRA registration and DORS data
- • Labeling and UKRP identification requirements
- • Technical documentation and evidence readiness
- • GB PMS, vigilance and FSCA obligations
- • Lifecycle changes and registration maintenance
Northern Ireland — Separate EU-Based Route
Northern Ireland follows a different regulatory pathway. EU MDR 2017/745 and EU IVDR 2017/746 apply to devices placed on the Northern Ireland market. CE marking remains central, and UKNI may apply where a UK Notified Body is used for mandatory third-party conformity assessment under the Northern Ireland route.
NKB Regovanta helps manufacturers avoid treating Northern Ireland as an extension of Great Britain registration. We assess the correct EU regulatory pathway, economic-operator requirements, CE / UKNI implications, registration obligations and the interaction between the NI and GB commercial strategy.
Dual Market Strategy
We structure labeling, packaging, and regulatory dossiers to allow seamless commercialization across both Great Britain and Northern Ireland without duplicated compliance friction.
UK Responsible Person — More Than Regulatory Representation
The effectiveness of the UKRP relationship depends on access to accurate and current information. A strong manufacturer–UKRP interface should clearly define:
Frequently Asked Questions
Key regulatory answers regarding UK MHRA registration, UKRP representation, and CE recognition.
Do all medical devices need MHRA registration before being sold in Great Britain?
Yes. All medical devices, IVDs, custom-made devices and systems or procedure packs falling within applicable UK registration requirements must be registered with the MHRA via the DORS portal before being placed on the Great Britain market.
When does an overseas manufacturer need a UK Responsible Person (UKRP)?
Any manufacturer established outside the United Kingdom wishing to place medical devices or IVDs on the Great Britain market must appoint a single UK Responsible Person (UKRP) based in the UK to act on its behalf.
Is UKCA marking mandatory for every medical device in Great Britain today?
No. Eligible CE-marked medical devices continue to be accepted in Great Britain under current transitional arrangements. Devices compliant with EU MDR or EU IVDR may currently be placed on the GB market up to 30 June 2030, while Directive-based devices follow their applicable transition periods.
Can the same regulatory strategy be used for Great Britain and Northern Ireland?
No. Great Britain operates under the UK Medical Devices Regulations 2002 (as amended), whereas Northern Ireland continues to follow the EU MDR 2017/745 and EU IVDR 2017/746 frameworks under the Northern Ireland Protocol. Manufacturers must assess the two routes separately.
Can NKB Regovanta help coordinate laboratory testing for UK submissions?
Yes. Where third-party studies are required (biocompatibility, electrical safety, software V&V, IVD performance), NKB Regovanta defines the regulatory testing protocol and coordinates with established, accredited laboratories.
Can NKB Regovanta support In Vitro Diagnostic (IVD) devices in the UK?
Yes. We support IVD regulatory category assessment, analytical and clinical performance evidence planning, laboratory coordination, UKRP appointment, MHRA registration, and post-market compliance.
What ongoing obligations exist after MHRA registration?
Registration is not the end of compliance. Manufacturers and their UKRPs must maintain active Post-Market Surveillance (PMS), vigilance and serious incident reporting via MORE, periodic registration updates, and regulatory assessment of all design and manufacturing changes.
Can NKB Regovanta review an existing UK registration or UKRP setup?
Yes. We frequently conduct independent audits of existing MHRA registrations, UKRP mandate agreements, technical dossiers, labeling, and PMS procedures to identify and remediate regulatory gaps.
Your Trusted Partner for UK Market Access
From UKRP services to MHRA registration and ongoing compliance, NKB Regovanta ensures your devices reach the UK market with confidence and compliance.
Talk to Our UK ExpertsLaunch and Maintain Your Medical Devices & IVDs Across the UK
Our senior regulatory team coordinates UKRP mandates, MHRA DORS registrations, UKCA marking, and post-market compliance.