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 manufacturers navigating complex regulatory landscapes.

**Expertise & scope**
* Expert services for MHRA registration.
* UK Responsible Person (UKRP) appointments.
* CE marking under MDR and IVDR.
* Development of MDR / IVDR Technical Files or Documentation to demonstrate safety and performance.
* Consultancy for IVDR Regulation, Technical File, Classification, and PRRC.
* Consultancy for MDR Classification, Technical File, Consultants, Clinical Evaluation, PMS Report, Risk Management, Article 117, Software CE Marking, Biocompatibility Test, and PRRC.
* Services include FSC & Apostille.

**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee for secure cloud-based document delivery.

Additional information

i3CGlobal (UKRP) emphasizes a commitment to fair and transparent pricing, attracting a global clientele. They highlight their ability to initiate projects swiftly due to readily available regulatory consulting team manpower. Data security is a key focus, evidenced by their ISO 27001 certification, ensuring the confidentiality and integrity of client information through secure cloud-based document management.

Key Highlights

  • i3CGlobal (UKRP) specializes in UK Responsible Person (UKRP) appointments for medical devices and IVDs. Source
    “According to UK MDR 2019, the UK Responsible Person must be appointed to ensure compliance with the Medicines Health and Regulatory Authority guidelines for placing medical devices and Invitro Diagnostic devices in the United Kingdom.”
  • They offer expert services for MHRA registration, essential for placing devices on the UK market post-Brexit. Source
    “Post-Brexit all foreign manufacturers must register and list the device with MHRA before exporting to the UK.”
  • Certified with ISO 27001 for data security, ensuring confidentiality and integrity of client information. Source
    “Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information.”
  • Provides comprehensive support for both MDR and IVDR CE marking and technical documentation. Source
    “MDR / IVDR Technical File or Documentation is to demonstrate the safety and performance of medical devices.”

Certifications & Trust Signals

  • ISO 27001 certified for data security. Source
    “Certified with ISO 27001 for data security”
  • Operates with a 24/7 uptime guarantee for secure cloud document delivery. Source
    “Operating around the clock with a 24/7 uptime guarantee”

Buyer Snapshot

Best for
  • Manufacturers seeking UK Responsible Person services.
  • Companies needing assistance with MHRA registration.
  • Businesses requiring CE marking under MDR/IVDR.
How engagement typically works
  • Project-based consultancy.
  • Partnership for regulatory compliance.
Typical deliverables
  • UKRP appointment and agreement.
  • MHRA registration support.
  • Technical documentation for MDR/IVDR.
  • CE marking strategy and execution.
Good to know
  • Best when requiring specialized expertise in UK medical device regulations.
HQ: London, UK
Languages: English
Timezones: Europe/London
Status: listed

Services & Capabilities

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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, indicating the UKRP's operation with the manufacturer's agreement and device compliance with applicable laws.
UK Entity Country
England
Vigilance Support
No
Post Market Support
Yes
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