IMed Consultancy (UKRP)
IMed Consultancy Ltd
IMed Consultancy offers expert UKRP services for medical devices and IVDs, ensuring compliance with UK regulations post-Brexit. They provide direct access to UK-based QA/RA experts for market entry.
IMed Consultancy specializes in UKRP (UK Responsible Person) services, guiding medical device and IVD manufacturers through the complexities of the UK market. Following Brexit, European regulations no longer apply, and IMed Consultancy ensures your products meet the specific UK requirements, including demonstrating compliance with UK MDR 2002 and managing MHRA registrations. Benefit from direct access to a dedicated team of UK-based QA/RA experts who provide strategic guidance and support for your market entry. IMed Consultancy acts on your behalf, offering a qualified and experienced UKRP to navigate regulatory changes and protect your market position. They are equipped to support global manufacturers with their regulatory and compliance needs within the UK.
About
**Who they are**
IMed Consultancy (UKRP) provides expert UK Responsible Person (UKRP) services, specifically tailored for medical devices and In Vitro Diagnostic (IVD) devices. They facilitate market access in the UK following Brexit.
**Expertise & scope**
* Direct access to UK-based Quality Assurance and Regulatory Affairs (QA/RA) experts.
* Ensuring compliance with UK regulations for medical devices and IVDs.
* Facilitating market entry for manufacturers.
**Reputation / proof points**
* Coverage exclusively within the UK.
* Services delivered in English.
IMed Consultancy (UKRP) provides expert UK Responsible Person (UKRP) services, specifically tailored for medical devices and In Vitro Diagnostic (IVD) devices. They facilitate market access in the UK following Brexit.
**Expertise & scope**
* Direct access to UK-based Quality Assurance and Regulatory Affairs (QA/RA) experts.
* Ensuring compliance with UK regulations for medical devices and IVDs.
* Facilitating market entry for manufacturers.
**Reputation / proof points**
* Coverage exclusively within the UK.
* Services delivered in English.
Additional information
IMed Consultancy (UKRP) focuses on simplifying the complexities of UK regulatory compliance for medical device and IVD manufacturers. Their service as a UK Responsible Person ensures that non-UK based manufacturers have a legal entity within Great Britain to act on their behalf with regulatory authorities. This is crucial for placing devices on the market and maintaining ongoing compliance. Buyers should be prepared to provide detailed technical documentation and information about their quality management systems to facilitate the UKRP appointment and ongoing regulatory activities.
Key Highlights
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Specializes in UK Responsible Person services for medical devices and IVDs.
Source
“IMed Consultancy offers expert UKRP services for medical devices and IVDs, ensuring compliance with UK regulations post-Brexit.”
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Provides direct access to UK-based QA/RA experts.
Source
“They provide direct access to UK-based QA/RA experts for market entry.”
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Facilitates market entry into the UK post-Brexit.
Source
“ensuring compliance with UK regulations post-Brexit. They provide direct access to UK-based QA/RA experts for market entry.”
Certifications & Trust Signals
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Established UK presence for regulatory representation.
Source
“IMed Consultancy (UKRP)”
Buyer Snapshot
Best for
- Non-UK based manufacturers of medical devices and IVDs
- Companies seeking a UK Responsible Person for market access
How engagement typically works
- Direct engagement with UK-based QA/RA experts
- Focus on regulatory compliance and market entry
Typical deliverables
- UK Responsible Person appointment
- Regulatory compliance support for UK market
- Facilitation of market entry
Good to know
- Best when the primary need is UK market access and UKRP representation.
HQ:
Banbury, UK
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:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
GBP 1,400
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:
Yes
Device Classes Supported:
IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports IVDR
true
Supports GB
true
UK Entity Country
England
Device Classes Supported
Class I, IIa, IIb, III (implied by medical device and IVD services)
Supports MDR
true
Vigilance Support
true
Post Market Support
true
Onboarding Steps
Contact for consultation and tailored solutions.
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