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 (UKRP) services for In Vitro Diagnostic (IVD) manufacturers. They focus on ensuring compliance with MHRA regulations for devices intended for the UK market.
**Expertise & scope**
* Provision of UK Responsible Person services.
* Ensuring compliance with MHRA regulations for IVD devices.
* Facilitating market access for devices within the United Kingdom.
**Reputation / proof points**
* Established provider of UKRP services.
Pathaway Services Ltd (UKRP) is a UK-based provider specializing in UK Responsible Person (UKRP) services for In Vitro Diagnostic (IVD) manufacturers. They focus on ensuring compliance with MHRA regulations for devices intended for the UK market.
**Expertise & scope**
* Provision of UK Responsible Person services.
* Ensuring compliance with MHRA regulations for IVD devices.
* Facilitating market access for devices within the United Kingdom.
**Reputation / proof points**
* Established provider of UKRP services.
Additional information
Pathaway Services Ltd (UKRP) focuses on the specific regulatory requirements for In Vitro Diagnostic devices entering the UK market. Their service as a UK Responsible Person is crucial for manufacturers who do not have an establishment within the UK. This role involves maintaining the technical documentation, ensuring conformity assessment procedures are followed, and acting as a point of contact with the MHRA. Engaging with Pathaway Services Ltd (UKRP) means manufacturers can navigate the UK's regulatory landscape with a dedicated partner.
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 without a UK establishment
- Companies seeking MHRA regulatory compliance
How engagement typically works
- Dedicated UKRP service provider
- Regulatory compliance support
Typical deliverables
- UK Responsible Person designation
- MHRA regulatory liaison
- Technical documentation oversight
Good to know
- Best when focused on IVD devices for the UK market.
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
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
