MDSS
MDSS GmbH
MDSS is a leading Authorized Representative and regulatory affairs specialist for medical and IVD devices. They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia, including EUDAMED registration support.
MDSS has over 30 years of experience as a trusted Authorized Representative and regulatory affairs consultant for Medical and In Vitro Diagnostic Devices. They provide essential in-country representation services across the EU, United Kingdom, Switzerland, USA, and Australia, acting as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent, and Australian TGA Sponsor. Specializing in EUDAMED registration, MDSS offers a full-service solution from initial setup to ongoing maintenance, ensuring continued market access for devices. They assist non-EU based companies in complying with regulations such as the AI Act and GPSR by appointing MDSS as their EU Representative. With a commitment to regulatory compliance and market access, MDSS serves as the pivotal contact for European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA. Their expertise empowers companies to navigate complex regulatory landscapes and achieve success in the European arena and beyond.
About
**Who they are**
MDSS is a specialist in regulatory affairs and an Authorized Representative for medical and IVD devices. They leverage decades of experience with national and European device databases to offer comprehensive services.
**Expertise & scope**
* Full-service EUDAMED registration solutions, from initial setup to ongoing maintenance.
* Management of EUDAMED actor and device registrations on behalf of manufacturers.
* Support for continued market access in the EU, with EUDAMED registration required by May 28, 2026.
* Assistance with establishing internal procedures and staff training for EUDAMED registration maintenance and updates.
* Outsourcing EUDAMED registration activities to their Authorised Representative, as strengthened by a recent European Commission proposal.
* Representation services across the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Decades of experience with national and European device databases.
MDSS is a specialist in regulatory affairs and an Authorized Representative for medical and IVD devices. They leverage decades of experience with national and European device databases to offer comprehensive services.
**Expertise & scope**
* Full-service EUDAMED registration solutions, from initial setup to ongoing maintenance.
* Management of EUDAMED actor and device registrations on behalf of manufacturers.
* Support for continued market access in the EU, with EUDAMED registration required by May 28, 2026.
* Assistance with establishing internal procedures and staff training for EUDAMED registration maintenance and updates.
* Outsourcing EUDAMED registration activities to their Authorised Representative, as strengthened by a recent European Commission proposal.
* Representation services across the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Decades of experience with national and European device databases.
Additional information
MDSS emphasizes that EUDAMED registration is an ongoing obligation, not a one-time task. Manufacturers need to develop new internal procedures and train staff for the continuous creation, maintenance, and updating of device registrations. The company highlights that a recent proposal from the European Commission aims to simplify requirements for medical device and IVD manufacturers and strengthens the ability to outsource these EUDAMED registration activities to an Authorised Representative. MDSS positions itself as the partner to manage these complex and ongoing regulatory duties, allowing manufacturers to focus on their core business.
Key Highlights
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MDSS offers comprehensive EUDAMED registration solutions, managing the process from initial setup to ongoing maintenance.
Source
“MDSS offers a full-service EUDAMED registration solution — from initial setup to ongoing maintenance.”
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Leverages decades of experience with national and European device databases for EUDAMED registrations.
Source
“Building on decades of experience with national and European device databases, MDSS offers a full-service EUDAMED registration solution”
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EUDAMED registration is mandatory by May 28, 2026, for continued EU market access, a process MDSS can manage.
Source
“Devices must be registered in EUDAMED by 28 May 2026* to ensure continued market access in the EU.”
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MDSS provides comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia.
Source
“They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia”
Certifications & Trust Signals
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MDSS is a leading Authorized Representative and regulatory affairs specialist for medical and IVD devices.
Source
“MDSS is a leading Authorized Representative and regulatory affairs specialist for medical and IVD devices.”
Buyer Snapshot
Best for
- Manufacturers seeking to outsource EUDAMED registration and ongoing maintenance.
- Companies needing comprehensive regulatory affairs support for medical and IVD devices.
How engagement typically works
- Full-service management of EUDAMED registrations.
- Partnership for ongoing regulatory compliance.
Typical deliverables
- EUDAMED Actor registration.
- EUDAMED Device registration.
- Ongoing EUDAMED registration maintenance and updates.
- Regulatory affairs consultation.
Good to know
- Best when manufacturers require expert handling of complex and evolving EUDAMED requirements.
HQ:
Hannover, Germany
Languages:
English, German, French, Spanish
Timezones:
CET, GMT
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU
Countries:
Germany, France, Spain, Italy, Netherlands
Industries:
Medical Devices, IVD
Pricing model:
Custom pricing
Modules Supported:
Actor/SRN, UDI/Devices
Submission Approach:
Portal
Managed Service Available:
Yes
Additional eudamed_onboarding_support Details
Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations
