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**
* Provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers located outside the UK.
* Guides manufacturers through the regulatory requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).
* Facilitates MHRA registration (PARD).
* Serves as a pivotal contact for the MHRA.
* Offers services that are an extension of a company's quality system to fulfill regulatory obligations in the UK.
**Reputation / proof points**
* Member of the UK Responsible Person Association (UKRPA).
* Has a physical presence in the UK, indicated by an address in Manchester.
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**
* Provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers located outside the UK.
* Guides manufacturers through the regulatory requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).
* Facilitates MHRA registration (PARD).
* Serves as a pivotal contact for the MHRA.
* Offers services that are an extension of a company's quality system to fulfill regulatory obligations in the UK.
**Reputation / proof points**
* Member of the UK Responsible Person Association (UKRPA).
* Has a physical presence in the UK, indicated by an address in Manchester.
Additional information
MDSS (UK Responsible Person) supports manufacturers in navigating the UK's regulatory landscape, particularly concerning the Medical Devices Regulations 2002. Their role is essential for non-UK based companies looking to place medical devices and in vitro diagnostic devices (IVDs) on the UK market. They assist with MHRA registration, a key step for market access. The company also stays abreast of regulatory changes, such as the MHRA's consultations on future UK medical device regulations and proposals for international recognition of device approvals.
Key Highlights
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Provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers outside the UK.
Source
“As your UK Responsible Person (UKRP), MDSS is ready to support Medical Device & IVD manufacturers located outside the UK.”
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Guides manufacturers through MHRA regulatory requirements and 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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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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Offers a UK address for regulatory contact, facilitating market access.
Source
“Our specialized expertise in European Regulatory Affairs positions us as your unparalleled Authorized Representative, providing a distinguished address in the EU, UK, Switzerland, USA, and Australia.”
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).”
Buyer Snapshot
Best for
- Non-UK based medical device and IVD manufacturers
- Companies seeking MHRA registration
How engagement typically works
- Regulatory guidance and support
- Facilitation of market access
Typical deliverables
- UK Responsible Person services
- MHRA registration support
- Compliance guidance
Good to know
- Best when the primary need is UK market access for medical devices and IVDs
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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