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 for medical devices and In Vitro Diagnostic Devices (IVDs), ensuring compliance with UK regulations following Brexit. They offer direct access to UK-based Quality Assurance and Regulatory Affairs (QA/RA) experts to facilitate market entry.
**Expertise & scope**
* Specialized UKRP services for medical devices and IVDs.
* Guidance on UK regulatory compliance post-Brexit.
* Access to UK-based QA/RA professionals.
* Support for market entry into the UK.
**Reputation / proof points**
* Coverage focused on the UK market.
* Services delivered in English.
IMed Consultancy (UKRP) provides expert UK Responsible Person (UKRP) services for medical devices and In Vitro Diagnostic Devices (IVDs), ensuring compliance with UK regulations following Brexit. They offer direct access to UK-based Quality Assurance and Regulatory Affairs (QA/RA) experts to facilitate market entry.
**Expertise & scope**
* Specialized UKRP services for medical devices and IVDs.
* Guidance on UK regulatory compliance post-Brexit.
* Access to UK-based QA/RA professionals.
* Support for market entry into the UK.
**Reputation / proof points**
* Coverage focused on the UK market.
* Services delivered in English.
Additional information
Engaging IMed Consultancy (UKRP) as your UK Responsible Person ensures that your medical devices and IVDs meet the specific regulatory requirements mandated by the UK government. Their service is designed to streamline the process of placing compliant products on the UK market. Buyers should be prepared to provide detailed technical documentation for their devices to facilitate the UKRP's regulatory assessment and oversight functions. The engagement focuses on establishing a clear line of communication and responsibility for regulatory adherence within the UK.
Key Highlights
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Expert 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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Facilitates market entry with direct access to UK-based QA/RA experts.
Source
“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
- Medical device manufacturers seeking UKRP services.
- IVD manufacturers requiring UK market access.
How engagement typically works
- Direct access to UK-based QA/RA experts.
- Focus on regulatory compliance and market entry.
Typical deliverables
- UK Responsible Person designation.
- Guidance on UK regulatory requirements.
- Support for post-Brexit compliance.
Good to know
- Best when direct access to UK-based regulatory expertise is a priority.
HQ:
Banbury, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find 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
Yes
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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