Growth_Medics_logo_color3_lightcolor-pyvsxlj530qbs48awo7scqkz7heb26bfifj62gpjkm.png
Free Market Scan

Regulatory Importer for Medical
and IVD Devices in the United
Kingdom

MHRA compliant importing services in the UK. GrowthMedics ensures fast, compliant and cost-effective market entry.
Check our free scan
or
Book a free consultation

Regulatory Importer for Medical
and IVD Devices in the United
Kingdom

MHRA compliant importing services in the UK. GrowthMedics ensures fast, compliant and cost-effective market entry.
Check our free scan

Introduction

What We Do

Client results

Expertise

Why Choose Growth Medics
FAQ

Simplify Market Entry in the UK of your Medical and IVD devices compliant with the MHRA

As your independent regulatory importer in the UK, GrowthMedics verifies your compliance with the UK MDR Regulations and Medicines and Medical Devices Act Framework (MMDA) to facilitate placement of your medical and IVD devices on the UK market, enabling direct commercial shipments to your retailers, distributors or end-users. We work closely with your regulatory team to facilitate a smooth onboarding and shipping process.
GrowthMedics’ full-suite market expansion services support you in every stage of your growth, from importing, shipping, to sales representation, clinical evaluations, KOL engagements and distribution development services.

GrowthMedics, your single independent UK MHRA
importer for your medical
and IVD diagnostic devices

To legally place medical devices and IVDs on the Great Britain (GB) market, manufacturers of all classes of medical devices, refurbished or re-labeled, custom-made, IVDs or procedure or system packs containing at least one medical device, need to appoint an importer compliant with the UK Medical Devices Regulations.
Our services ensure traceability and accountability under UK MDR 2002 and are critical for smooth and lawful market entry. GrowthMedics facilitates and simplifies compliant importing in the United Kingdom.

Compliance Assurance

We will ensure complaint products are placed on the UK market. We verify that the manufacturer has completed conformity assessment procedures, prepared technical documentation and applied the proper UKCA/CE marking.

Labelling

We will comply with the DUI, IFU and labelling requirements, registering trade name/trademark, and postal address on the product, packaging, or accompanying documents. We verify that labeling includes correct UKRP details and UKCA or CE marking.

Risk Management

If a product poses a safety risk, we will notify the relevant enforcement authority and take corrective actions such as product withdrawal or recall.

Storage & Transport Conditions

We take responsibility for maintaining product integrity during storage and transit, and must keep the Declaration of Conformity and technical files available for competent authorities.

Market Surveillance

We will cooperate with surveillance authorities, providing product compliance information upon request within 10 years of market placement.

Traceability

We ensure full traceability of your medical and IVD devices to track shipments, manage compliance, and address risks or complaints effectively. Our team conducts regular sample audits to verify documentation accuracy and confirm that deliveries meet regulatory and quality standards throughout the supply chain.

Registering Your Device

Registration is required before any device is placed on the GB market.. Failure to register results in being unable to legally market your device in Great Britain. With your UKRP and the MHRA to register and notify your medical and IVD devices.

GrowthMedics provides complete solutions, including acting as your licensed importer or arranging partnerships with authorized license holders—ensuring full UK MHRA compliance, importer registration, GDP-compliant storage, and seamless CE to UKCA transition support.
Book a Meeting
Request a Free Importer Scan

What Our Clients Say

“We really appreciate the dedication and methodical approach by GrowthMedics team demonstrated in helping our registration and marketing in the EU market”

Luke Gao PhD

CEO Panacyte Scientific LLC.

“We have been working with Growth Medics to increase awareness of our software solutions in the Medical Device Industry. Growth Medics team have a deep knowledge and understanding or our industry and were very professional”

Louis Albert - CEO

Matrix Reg

“The team is diligent and professional in its approach to understanding our company and creating pathways to new markets. We recommend GrowthMedics as a partner to assist with European expansion plans”

Managing Director-Principal

ClearPoint Medical Inc.

“GrowthMedics’ team is highly strategic and experienced professionals. Their extensive knowledge of the global healthcare market, along with their targeted approach to business development, makes them a great asset to work alongside”

Kareem Sherif

President IV Glove

“When working with the managing director of GrowthMedics, he was always incredibly helpful and understanding of our organizational needs regarding expansion in international markets. He took his time to understand our business and product offering to help provide tailored solutions aimed at taking our business to the next level”

Chad Gottschalk

International sales manager (Bionix Corp.),

“GrowthMedics played a vital role in our international development. Their network, team, experience and deep industry knowledge helped us grow our market share in Europe. By acting as our European sales arm, they have successfully established and managed a network of distributors and clinics across European markets”

Sebastien Lachapelle

President – Dispomed

“Expanding into new markets internationally recently has been especially challenging. GrowthMedics gets doors opened, is very efficient and follows through. We highly recommend GrowthMedics for their help expanding our footprint in Europe and MENA.”

J. Mark Strong

Global Medical Business Development Director (Multi Radiance Medical Inc.)

“ We are delighted to work with Growth Medics in developing the European Union market. The team have been most professional, diligent and committed to our joint success”

Max Kanarsky

President & CEO (Quant Medical Inc.)
xsv
Genoray (2)
Fisscure (1)
Dispomed (1)
CPM (1)
CPC (1)
Barco (4)
HiCura (1)
Matrix Requirements (1)
MultiRadiance (2)
Proteomics (1)
Surfacide logo2

What Our Clients Say

“We really appreciate the dedication and methodical approach by GrowthMedics team demonstrated in helping our registration and marketing in the EU market”

Luke Gao PhD

CEO Panacyte Scientific LLC.

“We have been working with Growth Medics to increase awareness of our software solutions in the Medical Device Industry. Growth Medics team have a deep knowledge and understanding or our industry and were very professional”

Louis Albert - CEO

Matrix Reg

“The team is diligent and professional in its approach to understanding our company and creating pathways to new markets. We recommend GrowthMedics as a partner to assist with European expansion plans”

Managing Director-Principal

ClearPoint Medical Inc.

“GrowthMedics’ team is highly strategic and experienced professionals. Their extensive knowledge of the global healthcare market, along with their targeted approach to business development, makes them a great asset to work alongside”

Kareem Sherif

President IV Glove

“When working with the managing director of GrowthMedics, he was always incredibly helpful and understanding of our organizational needs regarding expansion in international markets. He took his time to understand our business and product offering to help provide tailored solutions aimed at taking our business to the next level”

Chad Gottschalk

International sales manager (Bionix Corp.),
“GrowthMedics played a vital role in our international development. Their network, team, experience and deep industry knowledge helped us grow our market share in Europe. By acting as our European sales arm, they have successfully established and managed a network of distributors and clinics across European markets”

Sebastien Lachapelle

President – Dispomed
“Expanding into new markets internationally recently has been especially challenging. GrowthMedics gets doors opened, is very efficient and follows through. We highly recommend GrowthMedics for their help expanding our footprint in Europe and MENA.”

J. Mark Strong

Global Medical Business Development Director (Multi Radiance Medical Inc.)
“ We are delighted to work with Growth Medics in developing the European Union market. The team have been most professional, diligent and committed to our joint success”

Max Kanarsky

President & CEO (Quant Medical Inc.)
9
Genoray (2)
Fisscure (1)
CPM (1)
Dispomed (1)
CPC (1)
Barco (4)
HiCura (1)
IVG (1)
Matrix Requirements (1)
MultiRadiance (2)
Proteomics (1)
Surfacide logo2
Why Choose GrowthMedics As Your Independent Regulatory Importer in the UK?
We make importing hassle-free on the UK market. Having your distributors (or multiple) can create market complications and channel conflicts. More-over will it increase your incompliance risks and limit your independence on the market to ship directly or ship to multiple distributors.
We help you avoid dependency on local distributors who may have competing interests or limited regulatory capacity.  GrowthMedics works with manufacturers of all sizes to build importing strategies that scale with your business and eliminate regulatory bottlenecks.
All Logistics and Importing Services
With GrowthMedics we provide the expertise as your independent regulatory importer UK, to scale your sales:

Cost-effective, neutral, conflict-free compliance partner with importing services in UK, EU and CH

Reduced risk of non-conformance or customs delays

No need to establish your own UK legal entity

Faster time-to-market and improved supply chain transparency

Optional integration of warehousing and shipping services or sales development services to accelerate your sales revenue

Start Importing your Medical and IVD Devices in the UK Today
Request a quote or speak with our experts to discuss how your products can be imported compliant and efficient.
Book a Free Consultation with our experts
FAQ

Can’t find the answer you are looking for? 
Reach out to us here.

Any non-UK manufacturer of medical devices or IVDs must appoint a UK-based importer to place their products on the UK market. This importer must ensure compliance with UK MDR 2002 regulations and coordinate with the appointed UK Responsible Person (UKRP).
Ans. MHRA-compliant importer is responsible for verifying CE/UKCA markings, reviewing documentation, ensuring proper labeling, and managing post-market surveillance. They must also ensure safe storage, report non-compliance, and cooperate with market surveillance authorities.
Ans. The UK Responsible Person (UKRP) acts on behalf of the manufacturer to register products with the MHRA and maintain technical documentation. The importer physically brings the product into the UK and ensures its compliance before it is placed on the market. Both roles are legally required for non-UK manufacturers.
Ans. Yes! GrowthMedics and its subsidiary, GrowthImports, can act as your regulatory importer and coordinate closely with your designated UKRP—or serve as both—ensuring full compliance and simplified market entry.
Ans. Failure to register your medical or IVD device with the MHRA will prevent you from lawfully placing it on the Great Britain market. Non-compliance can result in product recalls, penalties, and supply chain disruption.
Expansion insights
Insights for Lifescience Companies

See More

Unveiling the dynamics of European Orthopaedic & Spinal Marke

In the ever-evolving landscape of the orthopedic and surgical industries, expanding into the European orthopaedic and spinal market offers immense

Read more

Conquering European and MENA medical device markets with local sales representation!

Managing international sales from oversees, without having local adequate sales representation, brings a variety of operational complexities and significantly delays

Read more

The European Hospital Purchasing Landscape

Selling Medical Devices to European Hospitals The European hospital purchasing landscape offers significant opportunities for manufacturers and distributors of medical

Read more

Subscribe

Select topics and stay current with our latest insights
Case Studies GrowthMedics

Download and profit of the insights of the European market

Accelerating global growth

A complete guide for selling medical and IVD devices successful in Europe