MDSS Group

What MDSS Group does

MDSS Group is a privately held German regulatory consulting firm headquartered in Hannover, specializing in in-country representation and regulatory compliance services for medical devices, in vitro diagnostics (IVDs), and cosmetic products. The company serves non-EU, non-UK, and non-Swiss manufacturers seeking to access regulated markets by acting as their Authorized Representative (EC REP), UK Responsible Person (UKRP), Swiss Authorized Representative (CH-REP), U.S. Agent for FDA matters, and Australian TGA Sponsor. With over 30 years of regulatory experience, MDSS also provides EU Representative services under the General Product Safety Regulation (GPSR) and GDPR, legal representation for clinical investigation sponsors, national product registrations across EU member states (Italy, Spain, Portugal, Latvia, Greece, Slovakia, Lithuania), and regulatory strategy consulting.

The business operates through a corporate group structure with three wholly owned subsidiaries: MDSS Consulting GmbH (regulatory consulting for medical devices and IVDs), MDSS-Impex GmbH (Free Sales Certificates and import/export services), and the MDSS Cosmetics sub-brand (Responsible Person services for cosmetics under EU/UK Cosmetics Regulations and FDA MoCRA). Revenue is generated through professional services fees on a quote-based, project-specific basis, with services delivered via direct B2B enterprise sales to manufacturers. The firm is a member of four key industry associations — EAAR, UKRPA, Swiss Medtech, and MTAA — and maintains offices in Germany, the United States, the United Kingdom, Switzerland, and Australia. MDSS is led by President Ludger Möller and operates as a founder/management-owned entity with no disclosed external investment or parent company.

Name

MDSS Group

Legal name

MDSS GmbH

Website

https://mdssar.com

Company type

Private

Operating status

Operating

Short description

MDSS Group is a German regulatory consulting firm providing in-country authorized representation and compliance services for medical device, IVD, and cosmetic manufacturers seeking market access across the EU, UK, Switzerland, USA, and Australia.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Professional, Scientific, and Technical Services (541), All Other Legal Services (541199)

SIC

Services-Legal Services (8111)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industries

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)

Keywords

• Regulatory affairs consulting
• Authorized representative services
• Medical device compliance
• EU MDR IVDR consulting
• In-country representation

Headquarters

HQ city

Hannover

HQ country

Germany

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Regulatory Consulting Services: MDSS generates revenue through professional services fees for regulatory strategy consulting, authorized representative services, and compliance support for medical devices and IVDs. Services include pre-submission support, marketing authorization applications, EU MDR/IVDR compliance, and various in-country representation services across EU, UK, Switzerland, USA, and Australia.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

MDSS Group provides in-country authorized representation and regulatory consulting services for non-EU/UK manufacturers of medical devices, IVDs, and cosmetic products. The company acts as a legal liaison between foreign manufacturers and regulatory authorities across EU, UK, Switzerland, USA, and Australia, handling CE marking, EU MDR/IVDR compliance, FDA liaison, and national registrations. Additional offerings include Free Sales Certificates, importer services, and comprehensive regulatory strategy consulting from pre-submission through post-market surveillance.

Product overview

MDSS Group is a regulatory consulting and authorized representative services firm providing in-country representation across global markets. The company offers a comprehensive portfolio of regulatory services including European Authorized Representative (EC REP), EU GPSR and GDPR representatives, UK Responsible Person, Swiss CH-REP, US Agent, and Australian TGA Sponsor services. Additional offerings include national registrations for EU member states, Free Sales Certificates through MDSS-Impex GmbH, importer services, and regulatory consulting for medical devices and IVDs. The MDSS Cosmetics sub-brand handles cosmetic product compliance under EU/UK Cosmetics Regulations and FDA MoCRA. The company operates as a unified service organization rather than a software product platform.

Differentiator

Problem solved

Functional benefit

Brands

• MDSS Cosmetics: Provides services as Responsible Person (RP) for the Cosmetics Representation in the EU and UK under the Cosmetics Regulations, and as U.S. Agent under the FDA Regulations (MoCRA).

Products and services

• European Authorized Representative (EC REP) Legal representation service for non-EU manufacturers to ensure compliance with EU product regulations and CE marking requirements, including maintaining technical documentation and handling regulatory inquiries.
• EU Representative – GPSR Representation service for non-EU manufacturers to ensure compliance with the EU General Product Safety Regulation, including product safety compliance and technical documentation maintenance.
• EU Representative – GDPR Legal representation for non-EU businesses processing personal data of EU individuals, acting as contact point for data subjects and regulatory authorities under GDPR.
• Legal Representative for the Sponsor of Clinical Investigations Legal representation for clinical investigation sponsors based outside the EU, handling communication and ensuring adherence to sponsor obligations under EU Regulation 2017/745.
• National Registration Product notification services for EU Member States including Italy, Spain, Portugal, Latvia, Greece, Slovakia, and Lithuania, managing registrations with competent authorities.
• Free Sales Certificate Import process services for Europe through MDSS-Impex GmbH, providing Free Sales Certificates for medical devices entering the European market.
• Importer of Products Import services for products entering the European market, ensuring compliance with EU import requirements and regulations.
• U.S. Agent FDA liaison representation for foreign companies, assisting with regulatory communications, facilitating inspections, and receiving official FDA correspondence.
• UK Responsible Person (UKRP) Legal representation for non-UK manufacturers to ensure compliance with UK product regulations and UKCA marking requirements, including MHRA product registration.
• Swiss Authorized Representative (CH-REP) Representation for non-Swiss manufacturers to ensure compliance with Swiss regulations, including Swissmedic product registration and market surveillance liaison.
• Australian TGA Sponsor Legal representation for foreign manufacturers to ensure TGA compliance, including ARTG registration and acting as official liaison for audits, recalls, and safety reporting.
• Regulatory Consulting Comprehensive regulatory strategy consulting for medical devices and IVDs, supporting pre-submissions, FDA marketing authorization applications, and EU MDR/IVDR compliance.
• MDSS Cosmetics Responsible Person services for cosmetics representation in the EU and UK under Cosmetics Regulations, and U.S. Agent services under FDA MoCRA regulations.

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• European Association of Authorized Representatives (EAAR)coreOthersMDSS is a member of EAAR, a professional association for authorized representatives in the medical device sector. Membership provides industry recognition, regulatory intelligence sharing, and participation in industry advocacy efforts.

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Direct peers

• Qserve Group: Qserve is a regulatory and quality consulting firm specializing in EU MDR/IVDR compliance for medical devices and IVDs, with similar authorized representative capabilities and a comparable European base.
• Advena Ltd: Advena is a UK-based authorized representative (UKRP) and regulatory consulting firm serving medical device manufacturers, directly competing for the same European representation mandate MDSS holds.
• Emergo by UL: Emergo (acquired by UL) is a direct peer providing regulatory consulting and authorized representative services (EC REP, UKRP, etc.) for medical device and IVD manufacturers globally, with comparable multi-jurisdiction coverage.

Broad incumbents

• TÜV Rheinland: TÜV Rheinland provides medical device testing, certification and regulatory representation services across multiple jurisdictions, operating at much larger scale than MDSS but with significant overlap in the authorized representative market.
• Intertek: Intertek provides medical device testing, certification and regulatory consulting globally with authorized representative capabilities, representing a much larger, publicly-listed competitor with overlapping service offerings.
• BSI Group: BSI is a UK-headquartered certification and regulatory body that offers UKRP services and broader medical device compliance support, competing directly with MDSS in UK and EU representation mandates.
• TÜV SÜD: TÜV SÜD is a major global testing, inspection and certification body that also offers authorized representative and medical device regulatory services as part of a much broader compliance portfolio, competing for the same clients with deeper balance-sheet capacity.
• DEKRA: DEKRA is a German-based global testing and certification organization with medical device regulatory services including authorized representation, overlapping significantly with MDSS's geographic base and service scope.

Others

• NAMSA: NAMSA is a medical device-focused contract research organization offering regulatory consulting, testing and quality systems services; it does not directly compete in authorized representation but addresses the same medical device manufacturers with adjacent regulatory services.
• Regulatory Affairs Professionals Society (RAPS): RAPS is a global professional society for regulatory affairs professionals in healthcare products; not a direct competitor but its membership ecosystem, training and advocacy directly intersect with MDSS's target buyer community.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about MDSS Group