UK Responsible Person for Medical Devices | OMC Medical
Engaging with MHRA
Looking for a UK Responsible Person? We help manufacturers in the US, China, Japan, South Korea, & more to meet MHRA compliance with ease.
OMC Medical UK – Your Gateway to Regulatory Success
At OMC Medical, we specialize in assisting medical device manufacturers in navigating the UK’s stringent regulatory framework. With expertise in UKCA marking, MHRA registration, and UKRP (UK Responsible Person) services, we ensure a seamless approval process for your products. Whether you need support with product classification, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in the UK provides comprehensive regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the growing UK healthcare market.
OMC Benefits
- Global Regulatory Expertise – Extensive experience in medical devices, IVDs, pharmaceuticals, and cosmetics.
- Compliance with UK Regulations – Specialized in UKCA marking, MHRA registration, and UKRP services.
- Seamless Market Entry – End-to-end support for product registration and regulatory approvals.
- Local Representation – Acting as your UK Responsible Person (UKRP) for smooth compliance.
- Dedicated Support – A team of regulatory professionals ensuring accuracy and efficiency.
- Risk Mitigation – Helping businesses stay compliant with evolving regulations.
Trust OMC Medical for hassle-free regulatory approvals and smooth market entry in the UK
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
The UK’s medical device and IVD market is strictly regulated by the MHRA, requiring full compliance for market approval. OMC Medical simplifies this process by providing expert assistance in UKCA marking, MHRA registration, UK Responsible Person (UKRP) services, supplier audits, QMS implementation, process validation, and regulatory documentation. Our services ensure smooth market entry, ongoing compliance, and a strong competitive position in the UK’s evolving healthcare sector
The UK’s cosmetics market is regulated by the UK Cosmetics Regulation, requiring strict compliance for product registration, safety assessments, and labeling. OMC Medical streamlines this process by offering expert guidance in UK Responsible Person (UKRP) services, regulatory approvals, local representation, supplier audits, and ongoing compliance management. We help brands navigate the UK’s evolving cosmetic regulations, ensuring seamless market entry and long-term success
The UK’s pharmaceutical market is regulated by the MHRA, requiring strict compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical simplifies this process by providing expert support in MHRA approvals, UK Responsible Person (UKRP) services, GMP compliance, supplier audits, and regulatory documentation. We help pharmaceutical companies navigate the UK’s evolving regulatory landscape, ensuring smooth market entry and sustained compliance.
OMC Medical provides expert support for businesses seeking market entry in the UK by acting as a UK Responsible Person (UKRP) and ensuring compliance with MHRA regulations. We assist with regulatory submissions, appointing a UKRP, and managing communications with UK authorities. Our expertise in the UK’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics. With OMC Medical, you gain a trusted partner to navigate complex compliance requirements efficiently
OMC Medical provides expert translation services tailored to the UK’s regulatory landscape, ensuring compliance with MHRA requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts. Our services help businesses navigate regulatory approvals and facilitate seamless market entry in the UK
Ensure Fast & Compliant Market Access to the UK
Are you a medical device manufacturer looking to sell in the UK market? You must appoint a UK Responsible Person (UKRP) to comply with MHRA UK medical device regulation and obtain the UKCA mark.
We provide expert UKRP services for both large enterprises & small manufacturers, ensuring smooth MHRA registration and compliance with ISO 13485 certification UK.
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in MHRA regulations, we assist businesses in navigating the UK’s complex compliance landscape, including product registration, quality assurance, UK Responsible Person (UKRP) services, and regulatory intelligence. Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success in the UK
What is a UK Responsible Person (UKRP)?
A UK Responsible Person acts as the legal representative for medical device manufacturers outside the UK. They ensure compliance with MHRA UK medical device regulations before a product can be placed on the UK market.
1: MHRA Registration & Compliance
- Verify technical documentation & compliance with UK MDR
- Ensure manufacturer follows conformity assessment procedures
- Register devices with MHRA for official UK approval
2: Maintain Compliance Records
- Store technical documentation, declaration of conformity & ISO 13485 certificates
- Provide records for MHRA UK medical device audits & inspections
3: Market Surveillance & Safety Measures
- Report incidents & complaints from users and healthcare professionals
- Collaborate with MHRA on preventive & corrective actions to ensure patient safety
4: Labeling & UKCA Mark Compliance
- Ensure UKRP details appear on packaging, IFU & product labeling
- Guide manufacturers on CE and UKCA marking requirements
5: Address Non-Compliance Issues
- Notify the MHRA & Approved Bodies of non-compliance
- Terminate legal agreements if the manufacturer fails to comply
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
Responsibilities of UK Responsible Person (UKRP)
- To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.
- The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.
Who Needs a UK Responsible Person?
- Medical device manufacturers outside the UK selling in England, Scotland, & Wales
- Companies requiring MHRA registration for medical devices
- Businesses needing ISO 13485 certification UK for regulatory approval
Why Choose Us as Your UK Responsible Person (UKRP)?
- MHRA-registered UKRP with expertise in UK medical device regulatory compliance
- Fast & hassle-free MHRA registration for seamless market entry
- Compliance with UK MDR and ISO 13485 certification UK
- 24/7 regulatory support & documentation management
Want to Sell Medical Devices in the UK?
Product
Registration
Authorized Representative
Product
Classification
Technical
Document
Quality
Assurance
Why Work With Us?
- Trusted by medical device manufacturers worldwide
- Expert regulatory consultants with a proven track record
- Quick turnaround time for UKRP registration & MHRA approvals
- 100% compliance assurance with UK MDR & ISO 13485 standards
Have a Business Query? Let us Talk
Frequently Asked Questions (FAQ)
Still Have Questions? Contact Us Now for a Free Consultation
Yes, but only if they formally assume all UKRP responsibilities. Many manufacturers prefer appointing an independent UKRP to avoid conflicts of interest.
Failure to comply with UK MHRA medical device regulations can lead to:
🚫 Device removal from the UK market
⚠️ Legal consequences for non-compliance
Choose a UKRP with:
✅ MHRA registration experience
✅ Proven expertise in UK medical device regulatory compliance
✅ 24/7 regulatory support & market access solutions
Still Have Questions? Contact Us Now for a Free Consultation