Pathaway Services Ltd (UKRP)
Pathaway Services Ltd
Pathaway Services Ltd is a UK-based provider of UK Responsible Person (UKRP) services for In Vitro Diagnostic (IVD) manufacturers. They ensure compliance with MHRA regulations for devices placed on the UK market.
Pathaway Services Ltd offers crucial UK Responsible Person (UKRP) services, essential for manufacturers of In Vitro Diagnostic (IVD) and Medical Devices who do not have an establishment within the UK. As mandated by the MHRA since January 1st, 2021, the UKRP acts as the local representative responsible for placing devices on the UK market. This role is vital for ensuring regulatory compliance, acting as a primary point of contact for the MHRA and UK customers, and sharing liability for the devices. Pathaway Services Ltd provides this critical support, ensuring that non-UK based manufacturers can effectively navigate the UK's regulatory landscape and maintain the safety and effectiveness of their products in the market. Their services are particularly important for companies seeking to access the UK market following Brexit, mirroring the established role of an EU Authorised Representative.
About
**Who they are**
Pathaway Services Ltd (UKRP) is a UK-based provider specializing in UK Responsible Person services for In Vitro Diagnostic (IVD) manufacturers. They focus on ensuring compliance for devices entering the UK market.
**Expertise & scope**
* Services specifically for UK Responsible Person (UKRP) requirements.
* Assistance with MHRA regulations for IVD devices.
* Facilitation of device placement on the UK market.
**Reputation / proof points**
* Established provider of UKRP services.
Pathaway Services Ltd (UKRP) is a UK-based provider specializing in UK Responsible Person services for In Vitro Diagnostic (IVD) manufacturers. They focus on ensuring compliance for devices entering the UK market.
**Expertise & scope**
* Services specifically for UK Responsible Person (UKRP) requirements.
* Assistance with MHRA regulations for IVD devices.
* Facilitation of device placement on the UK market.
**Reputation / proof points**
* Established provider of UKRP services.
Additional information
Pathaway Services Ltd (UKRP) focuses on the specific regulatory requirements for In Vitro Diagnostic (IVD) devices intended for the UK market. Their expertise lies in navigating the MHRA regulations, acting as the designated UK Responsible Person. This service is crucial for manufacturers outside the UK seeking to place their IVD products legally within Great Britain. They facilitate the necessary compliance steps to ensure market access.
Key Highlights
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Specializes in UK Responsible Person (UKRP) services for IVD manufacturers.
Source
“Pathaway Services Ltd is a UK-based provider of UK Responsible Person (UKRP) services for In Vitro Diagnostic (IVD) manufacturers.”
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Ensures compliance with MHRA regulations for devices on the UK market.
Source
“They ensure compliance with MHRA regulations for devices placed on the UK market.”
Certifications & Trust Signals
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Established UK-based provider.
Source
“Pathaway Services Ltd is a UK-based provider of UK Responsible Person (UKRP) services for In Vitro Diagnostic (IVD) manufacturers.”
Buyer Snapshot
Best for
- IVD manufacturers needing a UK Responsible Person
- Companies seeking MHRA compliance for UK market entry
How engagement typically works
- Direct service provision
- Regulatory compliance support
Typical deliverables
- Designation as UK Responsible Person
- Guidance on MHRA regulations
- Support for device market placement
Good to know
- Best when focused on In Vitro Diagnostic devices
- Best when targeting the UK market
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:
Retainer
Starting from:
GBP 2,200
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
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
false
Supports IVDR
true
Supports GB
true
Vigilance Support
true
Post Market Support
true
UK Entity Country
England
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