MDSS (UK Responsible Person)
MDSS provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers outside the UK, ensuring compliance with MHRA regulations for market access.
MDSS acts as your dedicated UK Responsible Person (UKRP), a crucial role for medical device and IVD manufacturers located outside the UK who wish to place their products on the UK market. We ensure your compliance with the Medical Devices Regulations 2002 and guide you through the necessary MHRA registration processes (PARD). With over 30 years of experience in regulatory affairs, MDSS offers comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia. Our expertise extends to navigating complex regulatory landscapes, including the AI Act and General Product Safety Regulation (GPSR) in the EU. We are committed to facilitating your market access by managing regulatory requirements, allowing you to concentrate on innovation and your core business. MDSS stays abreast of regulatory changes, such as the MHRA's consultations on future UK medical device regulations and international recognition frameworks.
About
**Who they are**
MDSS (UK Responsible Person) acts as a crucial intermediary for medical device and IVD manufacturers outside the UK, ensuring their products can access the UK market by complying with MHRA regulations.
**Expertise & scope**
* Serves as the UK Responsible Person (UKRP) for non-UK based manufacturers of medical devices and in vitro diagnostic devices.
* Facilitates market access to the UK by managing regulatory requirements.
* Provides guidance on MHRA regulations and MHRA registration (PARD).
* Offers services that are an extension of a company's quality system to meet regulatory obligations.
* Engages with regulatory bodies including the MHRA.
**Reputation / proof points**
* Member of the UK Responsible Person Association (UKRPA).
* Has a presence in the UK, with an office located in Manchester.
MDSS (UK Responsible Person) acts as a crucial intermediary for medical device and IVD manufacturers outside the UK, ensuring their products can access the UK market by complying with MHRA regulations.
**Expertise & scope**
* Serves as the UK Responsible Person (UKRP) for non-UK based manufacturers of medical devices and in vitro diagnostic devices.
* Facilitates market access to the UK by managing regulatory requirements.
* Provides guidance on MHRA regulations and MHRA registration (PARD).
* Offers services that are an extension of a company's quality system to meet regulatory obligations.
* Engages with regulatory bodies including the MHRA.
**Reputation / proof points**
* Member of the UK Responsible Person Association (UKRPA).
* Has a presence in the UK, with an office located in Manchester.
Additional information
MDSS (UK Responsible Person) supports manufacturers in navigating the specific requirements of the UK Medical Devices Regulations 2002. Their role is essential for companies located outside the UK seeking to place medical devices and IVDs on the UK market. They are involved in guiding manufacturers through the MHRA registration process, known as PARD. As a member of the UK Responsible Person Association (UKRPA), MDSS demonstrates a commitment to the standards and practices expected of UKRPs.
Key Highlights
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Acts as the UK Responsible Person (UKRP) for medical device and IVD manufacturers located outside the UK.
Source
“The UK Responsible Person (UKRP) is required by the UK authorities for Medical Device & IVD manufacturers located outside the UK.”
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Facilitates market access to the UK by ensuring compliance with MHRA regulations.
Source
“In order to place medical devices in the UK market, non-UK manufacturers need to appoint a UK Responsible Person (UKRP) according to the Medical Devices Regulations 2002.”
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Provides guidance on MHRA regulations and MHRA registration (PARD).
Source
“Our dedicated team will guide you through all the regulatory requirements of the MHRA (Medicines and Healthcare products Regulatory Agency) and MHRA registration (PARD).”
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Is a member of the UK Responsible Person Association (UKRPA).
Source
“MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).”
Certifications & Trust Signals
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Offers services that are an extension of a company's quality system to fulfill regulatory obligations in the UK.
Source
“Our services are an extension of your quality system, fulfilling your regulatory obligations in the EU, UK, Switzerland, USA, and Australia.”
Buyer Snapshot
Best for
- Non-UK based medical device and IVD manufacturers
- Companies seeking UK market access
How engagement typically works
- Regulatory compliance support
- Liaison with MHRA
Typical deliverables
- UK Responsible Person services
- Guidance on MHRA regulations
- Support with MHRA registration (PARD)
Good to know
- Best when the primary need is UK market access for medical devices and IVDs from outside the UK.
Pricing
Model:
Onboarding + annual retainer
Public range:
Publicly listed: $499–$999 / Month
Notes:
Based on publicly listed information; final fees depend on scope.
“$499Per Month; $699Per Month; $999Per Month”
HQ:
London, 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:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
GBP 5,500
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
MHRA Support:
Yes
Vigilance Support:
Yes
Device Classes Supported:
IVD
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
UK Entity Country
England
Vigilance Support
MHRA registration (PARD) support mentioned
Onboarding Steps
Requires appointment of a UK Responsible Person (UKRP) according to the Medical Devices Regulations 2002.
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