CMC Medical Devices (UKRP)
CMC Medical Devices offers expert regulatory consulting and in-country representation for medical devices in the UK and globally. They ensure compliance and market access for manufacturers.
CMC Medical Devices (UKRP) is a specialized consultancy firm focused on regulatory affairs for medical devices, offering comprehensive services for international market access. Based in Spain, the company has established a significant presence with offices in the UK, Switzerland, USA, Australia, and China, enabling them to provide personalized regulatory solutions across diverse global markets. Their core offerings include in-country representation, such as UK Responsible Person (UKRP) services, European Authorized Representative (EC REP) services, and Swiss Authorized Representative (CH REP) services. These services are crucial for manufacturers outside these regions seeking to comply with local regulations and ensure their products can legally circulate in these markets. Beyond representation, CMC Medical Devices provides extensive consulting on regulatory compliance, including MDR, IVDR, ISO 13485, and EUDAMED registration. They assist with technical file preparation, quality management system establishment, and Free Sale Certificates, acting as a primary point of contact with local authorities to facilitate smooth communication and continuous compliance. Their expertise ensures that medical device manufacturers can navigate complex regulatory landscapes efficiently and successfully launch their products.
About
**Who they are**
CMC Medical Devices (UKRP) provides regulatory consulting and in-country representation for medical devices, ensuring compliance and market access for manufacturers globally, with a specific focus on the UK market.
**Expertise & scope**
* Acts as the UK Responsible Person (UKRP) for medical devices and in vitro diagnostic devices, a requirement for manufacturers based outside the UK post-Brexit.
* Assists with MHRA registration and UKCA certification.
* Serves as a primary point of contact with local authorities, facilitating smooth communication and continuous regulatory compliance.
* Offers representation services in multiple global regions including EU (EC REP), Switzerland (CH REP), Australia (TGA Sponsor), USA (FDA Agent), and China (NMPA Agent).
* Provides consulting on MDR, IVDR, ISO 13485, Manufacturing License, Import License, EUDAMED Registration, SWISSDAMED Registration, and GPSR.
* Facilitates the issuance of Free Sale Certificates.
* Supports product registration and post-market compliance.
**Reputation / proof points**
* CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.
* Member of the Association of Responsible Persons in the UK.
CMC Medical Devices (UKRP) provides regulatory consulting and in-country representation for medical devices, ensuring compliance and market access for manufacturers globally, with a specific focus on the UK market.
**Expertise & scope**
* Acts as the UK Responsible Person (UKRP) for medical devices and in vitro diagnostic devices, a requirement for manufacturers based outside the UK post-Brexit.
* Assists with MHRA registration and UKCA certification.
* Serves as a primary point of contact with local authorities, facilitating smooth communication and continuous regulatory compliance.
* Offers representation services in multiple global regions including EU (EC REP), Switzerland (CH REP), Australia (TGA Sponsor), USA (FDA Agent), and China (NMPA Agent).
* Provides consulting on MDR, IVDR, ISO 13485, Manufacturing License, Import License, EUDAMED Registration, SWISSDAMED Registration, and GPSR.
* Facilitates the issuance of Free Sale Certificates.
* Supports product registration and post-market compliance.
**Reputation / proof points**
* CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.
* Member of the Association of Responsible Persons in the UK.
Additional information
For manufacturers not based in the United Kingdom, appointing a UK-based Responsible Person is mandatory for placing medical devices and in vitro diagnostic devices on the British market. CMC Medical Devices UK, established in London, acts as this legal entity, assisting with compliance, MHRA registration, and UKCA certification. They manage communication with authorities and address inquiries promptly, ensuring a smooth market entry and ongoing compliance for foreign manufacturers.
Key Highlights
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CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.
Source
“CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.”
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Acts as the UK Responsible Person (UKRP) for medical devices and in vitro diagnostic devices.
Source
“Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.”
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Assists in completing MHRA registration and UKCA certification.
Source
“It maintains close communication and cooperation with authorities, assists in completing MHRA registration and UKCA certification, and performs manufacturer’s tasks in accordance with official instructions.”
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Member of the Association of Responsible Persons in the UK.
Source
“As a member of the Association of Responsible Persons in the UK, it has a professional international regulatory team and is qualified to act as the legal entity for manufacturers outside the UK.”
Certifications & Trust Signals
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Provides representation services in multiple global regions including EU, Switzerland, Australia, USA, and China.
Source
“RepresentationEU REPUK REPCH REPTGA SponsorFDA AgentChina REP”
Buyer Snapshot
Best for
- Foreign medical device manufacturers needing a UK Responsible Person (UKRP)
- Companies seeking assistance with MHRA registration and UKCA certification
- Manufacturers requiring representation in multiple global markets
How engagement typically works
- Acts as the primary point of contact with UK authorities
- Manages regulatory complexities on behalf of the manufacturer
- Provides ongoing compliance support
Typical deliverables
- UK Responsible Person services
- MHRA registration support
- UKCA certification assistance
- Global market representation
Good to know
- Best when manufacturers are based outside the United Kingdom
HQ:
Spain, ES
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 3,200
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
No
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
No
Vigilance Support:
Yes
Additional uk_rp Details
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
Contact form submission to initiate engagement with a consultant.
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