Independent informational listing
Emergo by UL
Medical-device regulatory consulting and market-access provider with public services covering EU MDR, IVDR, quality systems and representation.
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Independent informational listing
MDSS
European medical-device regulatory service provider offering representation, registration and consultancy support.
COMPANY OVERVIEW
About MDSS
MDSS publicly provides European regulatory services for medical-device manufacturers, including representative and consultancy-related activities. It may be relevant to non-EU manufacturers and other companies navigating EU MDR or IVDR obligations. Because authorized representation carries a defined legal role, buyers should review the mandate, responsibilities, vigilance process, document access and termination arrangements separately from any optional consulting work.
Primary locationGermany
CoverageEuropean Union and international manufacturers entering Europe
LanguagesGerman and English; additional language support may be available
Evidence reviewed2026-08-28
Publicly described services
- European authorized representation
- MDR and IVDR regulatory support
- Device registration support
- Technical-documentation guidance
- Vigilance and post-market support
- Regulatory communication
What to verify before appointment
Review the exact legal mandate, contracting entity, device scope, communication responsibilities, insurance and termination provisions.
Official sources
SERVICES AND SCOPE
Services shown on this profile
- European authorized representation
- MDR and IVDR regulatory support
- Device registration support
- Technical-documentation guidance
- Vigilance and post-market support
- Regulatory communication
COVERAGE
Where and how the provider works
Countries or regions
- European Union and international manufacturers entering Europe
Languages
- German and English
- additional language support may be available
VERIFICATION REFERENCES
Evidence and public references
These references were supplied for the public profile. Confirm current validity, applicable scope and issuing-body status before relying on any claim.
Evidence last reviewed: August 28, 2026
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