i3CGlobal (UKRP)
i3CGlobal
i3CGlobal is a trusted regulatory consulting company specializing in medical device compliance for the UK and EU markets. They offer expert services for MHRA registration, UK Responsible Person (UKRP) appointments, and CE marking under MDR and IVDR.
i3CGlobal provides world-class regulatory consulting services for medical device manufacturers seeking to place their products on the UK and EU markets. As a trusted partner, they offer comprehensive support for navigating complex regulatory landscapes, including MHRA registration and acting as the UK Responsible Person (UKRP) for post-Brexit compliance. Their expertise covers essential services such as MDR and IVDR technical file preparation, clinical evaluation reports, risk management, and CE marking. i3CGlobal is committed to ensuring your devices meet all applicable laws and guidelines, offering a reliable and efficient pathway to market access. They also provide support for UKCA technical documentation and ISO 13485 implementation. With a focus on data security, certified by ISO 27001, and operating 24/7, i3CGlobal ensures the confidentiality and integrity of your information while delivering services promptly. They are dedicated to providing fair pricing and on-time delivery, making them a go-to choice for manufacturers worldwide.
About
**Who they are**
i3CGlobal (UKRP) is a regulatory consulting company specializing in medical device compliance for the UK and EU markets. They are a trusted partner for healthcare product manufacturers worldwide.
**Expertise & scope**
* Expert services for MHRA registration and UK Responsible Person (UKRP) appointments.
* Support for CE marking under MDR and IVDR.
* Consulting on IVDR and MDR regulations, technical files, classification, and PRRC appointments.
* Services extend to Food, Cosmetic, and Drug regulatory consulting.
* Ensures compliance with EU, USA, and UK Regulations.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee, delivering documents securely via the cloud.
i3CGlobal (UKRP) is a regulatory consulting company specializing in medical device compliance for the UK and EU markets. They are a trusted partner for healthcare product manufacturers worldwide.
**Expertise & scope**
* Expert services for MHRA registration and UK Responsible Person (UKRP) appointments.
* Support for CE marking under MDR and IVDR.
* Consulting on IVDR and MDR regulations, technical files, classification, and PRRC appointments.
* Services extend to Food, Cosmetic, and Drug regulatory consulting.
* Ensures compliance with EU, USA, and UK Regulations.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee, delivering documents securely via the cloud.
Additional information
i3CGlobal emphasizes the complexity of regulatory documentation and registrations, recommending entrustment to their expert team. They highlight their readiness to initiate projects swiftly with dedicated full-time regulatory experts, prioritizing on-time delivery. The company promotes clear and consistent pricing, attracting international clients who value transparency and quality assurance. Data security is a key focus, with ISO 27001 certification ensuring the confidentiality and integrity of client information through secure cloud-based document management.
Key Highlights
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Designated as a UK Responsible Person for medical devices and IVDs.
Source
“We are designated as UK Responsible Person.”
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Specializes in UK MDR 2019 compliance and MHRA registration.
Source
“the UK Responsible Person must be appointed to ensure compliance with the Medicines Health and Regulatory Authority guidelines”
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Offers expertise in CE marking for both MDR and IVDR.
Source
“CE marking under MDR and IVDR.”
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Certified with ISO 27001 for data security.
Source
“Certified with ISO 27001 for data security”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Manufacturers seeking UK Responsible Person services.
- Companies needing MHRA registration support.
- Businesses requiring CE marking assistance under MDR/IVDR.
How engagement typically works
- Project-based consulting.
- Emphasis on swift project initiation and on-time delivery.
- Secure cloud-based documentation and communication.
Typical deliverables
- UK Responsible Person appointment.
- MHRA registration support.
- MDR/IVDR technical file consultation.
- Regulatory strategy and compliance guidance.
Good to know
- Best when requiring specialized regulatory expertise for UK market access.
HQ:
London, 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 1,200
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:
Yes
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Onboarding Steps
Requires a mutually signed agreement (letter of designation) between the manufacturer and the UKRP, including firm names and addresses for both parties.
UK Entity Country
England
Vigilance Support
Yes
Post Market Support
Yes
Device Classes Supported
Not explicitly stated, but support for MDR/IVDR implies all classes.
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