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 contact point for medical device and IVD manufacturers outside the UK, ensuring compliance with MHRA regulations for market access.
**Expertise & scope**
* Serves as the UK Responsible Person (UKRP) for non-UK manufacturers.
* Facilitates market access for medical devices and IVDs in the UK.
* Provides guidance on regulatory requirements from the MHRA (Medicines and Healthcare products Regulatory Agency).
* Assists with MHRA registration (PARD).
* Offers services as an EU Authorized Representative, U.S. Agent, and Australian Sponsor.
**Reputation / proof points**
* 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).
MDSS (UK Responsible Person) acts as a crucial contact point for medical device and IVD manufacturers outside the UK, ensuring compliance with MHRA regulations for market access.
**Expertise & scope**
* Serves as the UK Responsible Person (UKRP) for non-UK manufacturers.
* Facilitates market access for medical devices and IVDs in the UK.
* Provides guidance on regulatory requirements from the MHRA (Medicines and Healthcare products Regulatory Agency).
* Assists with MHRA registration (PARD).
* Offers services as an EU Authorized Representative, U.S. Agent, and Australian Sponsor.
**Reputation / proof points**
* 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).
Additional information
MDSS (UK Responsible Person) supports manufacturers in navigating the UK's regulatory landscape, particularly concerning the Medical Devices Regulations 2002. Their role as UKRP is essential for companies looking to place medical devices and in vitro diagnostic devices on the UK market. They are equipped to guide clients through the specific requirements set forth by the MHRA, including necessary registrations. Beyond UK services, MDSS also offers representation in the EU, USA, and Australia, positioning them as a comprehensive partner for international regulatory compliance.
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 for medical devices and IVDs in 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 registration (PARD) and other regulatory requirements.
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).”
Certifications & Trust Signals
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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).”
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Serves as a contact for the MHRA, alongside other national competent authorities.
Source
“At MDSS, we redefine excellence as your Authorized Representative, serving as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.”
Buyer Snapshot
Best for
- Non-UK based medical device and IVD manufacturers
- Companies seeking UK market access
How engagement typically works
- Regulatory representation
- Compliance guidance
Typical deliverables
- UK Responsible Person services
- MHRA registration support
- EU Authorized Representative services
Good to know
- Best when the primary need is UK market entry compliance for devices.
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
Best 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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