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) provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers located outside the UK. They act as a pivotal contact for regulatory authorities, including the MHRA.
**Expertise & scope**
* Ensuring compliance with UK Medical Devices Regulations 2002 for market access.
* Guiding manufacturers through MHRA registration (PARD).
* Serving as the UK Responsible Person for medical devices and in vitro diagnostic devices.
* Representing clients to the MHRA.
* Providing a distinguished address in the UK.
**Reputation / proof points**
* MDSS is a member of the UK Responsible Person Association (UKRPA).
* They have offices in the UK, Germany, and the USA.
MDSS (UK Responsible Person) provides expert UK Responsible Person (UKRP) services for medical device and IVD manufacturers located outside the UK. They act as a pivotal contact for regulatory authorities, including the MHRA.
**Expertise & scope**
* Ensuring compliance with UK Medical Devices Regulations 2002 for market access.
* Guiding manufacturers through MHRA registration (PARD).
* Serving as the UK Responsible Person for medical devices and in vitro diagnostic devices.
* Representing clients to the MHRA.
* Providing a distinguished address in the UK.
**Reputation / proof points**
* MDSS is a member of the UK Responsible Person Association (UKRPA).
* They have offices in the UK, Germany, and the USA.
Additional information
MDSS (UK Responsible Person) guides non-UK manufacturers through the regulatory requirements to place medical devices and IVDs on the UK market. This includes understanding and adhering to the Medical Devices Regulations 2002 and facilitating MHRA registration. Their services are designed to be an extension of a manufacturer's quality system, fulfilling specific regulatory obligations within the UK. They also keep abreast of regulatory changes, such as MHRA consultations on future UK medical device regulations and proposals for international recognition of medical device approvals.
Key Highlights
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MDSS 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).”
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Provides UK Responsible Person (UKRP) services for medical device and IVD manufacturers 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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Guides manufacturers through 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).”
Certifications & Trust Signals
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MDSS 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).”
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Acts as a pivotal contact for regulatory bodies including the MHRA.
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
- Regulatory compliance assurance
Good to know
- Best when manufacturers are located 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
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
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.
