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 UK Responsible Person (UKRP) services for medical devices and in vitro diagnostic devices, acting as a crucial link for manufacturers outside the UK. They are a subsidiary of CMC Group, based in London, United Kingdom.
**Expertise & scope**
* Appointed as a UK-based Responsible Person for manufacturers not based in the United Kingdom, assisting with compliance post-Brexit.
* Facilitate MHRA registration and UKCA certification processes.
* Act as the legal entity for foreign manufacturers in the UK market.
* Maintain close communication and cooperation with UK authorities.
* Address inquiries from authorities and regulatory bodies in the UK promptly.
**Reputation / proof points**
* Member of the Association of Responsible Persons in the UK.
CMC Medical Devices (UKRP) provides UK Responsible Person (UKRP) services for medical devices and in vitro diagnostic devices, acting as a crucial link for manufacturers outside the UK. They are a subsidiary of CMC Group, based in London, United Kingdom.
**Expertise & scope**
* Appointed as a UK-based Responsible Person for manufacturers not based in the United Kingdom, assisting with compliance post-Brexit.
* Facilitate MHRA registration and UKCA certification processes.
* Act as the legal entity for foreign manufacturers in the UK market.
* Maintain close communication and cooperation with UK authorities.
* Address inquiries from authorities and regulatory bodies in the UK promptly.
**Reputation / proof points**
* Member of the Association of Responsible Persons in the UK.
Additional information
For manufacturers outside the UK, appointing a UK Responsible Person is a post-Brexit requirement for placing medical devices and in vitro diagnostic devices on the British market. CMC Medical Devices UK, as a UK-based entity, fulfills this role by assisting manufacturers in preparing for compliance. They manage communication with regulatory bodies like the MHRA and support necessary registrations and certifications, ensuring a smoother market entry and ongoing compliance.
Key Highlights
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Provides UK Responsible Person (UKRP) services for medical devices and IVDs.
Source
“CMC Medical Devices offers UK Responsible Person (UKRP) for Medical Devices”
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Assists manufacturers not based in the UK with post-Brexit compliance requirements.
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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Facilitates 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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Is a UK-based subsidiary of CMC Group, located in London.
Source
“CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.”
Certifications & Trust Signals
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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.”
Buyer Snapshot
Best for
- Foreign manufacturers of medical devices and IVDs needing UK representation.
- Companies seeking assistance with MHRA registration and UKCA certification.
How engagement typically works
- Direct engagement with a UK-based subsidiary.
- Proactive communication with regulatory authorities.
Typical deliverables
- UK Responsible Person designation.
- Support for MHRA registration.
- Assistance with UKCA certification.
- Liaison with UK regulatory bodies.
Good to know
- Best when manufacturers are located outside the United Kingdom and require a local representative.
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
true
Supports IVDR
true
Supports GB
true
Vigilance Support
true
Post Market Support
true
UK Entity Country
England
Onboarding Steps
Contact form submission to initiate engagement with a consultant.
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