MDI Europa

What MDI Europa does

MDI Europa GmbH is a privately held, family-owned regulatory affairs consulting firm headquartered in Langenhagen, Germany (near Hanover), founded in 2000 by Martina Sander-Giesemann and Michael Bain as an affiliate partner of mdi Consultants in the United States. The firm specializes in providing EU market entry and compliance services to small and medium-sized medical device manufacturers, with a particular focus on non-EU manufacturers that require a European Authorized Representative under the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

The firm's core service offering spans European Authorized Representation, CE Marking support, and EU Importer services, complemented by add-on services for Switzerland (Swiss Authorized Representative) and Great Britain (UK Responsible Person) that address post-Brexit and Swiss MepV/IVDV regulatory fragmentation. Supporting consulting engagements include Technical File Compilation, Declaration of Conformity preparation, Certificates of Free Sale, OEM and private labeling guidance, and specialized CE consulting for electrical equipment compliance (EMC/LVD) and environmental requirements (WEEE/RoHS). The firm also maintains a public-facing online library of regulatory resources and publishes monthly news updates plus an in-depth newsletter for existing customers.

MDI Europa operates as a B2B professional services firm with a sales-led, direct engagement model targeting SME medical device manufacturers globally. Revenue is generated through per-engagement consulting fees and Authorized Representative retainer relationships, with no public pricing disclosure. The firm has reportedly registered hundreds of manufacturers for CE Marking with European competent authorities since 2000. Customer acquisition is conducted primarily through content marketing (online regulatory library), email newsletters, and LinkedIn. The firm is small (1–10 employees), has no institutional or venture capital backing, and has been operated as a multi-generational family business since 2004.

Name

MDI Europa

Legal name

mdi Europa GmbH

Website

https://mdi-europa.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

1–10 employees

Short description

MDI Europa GmbH is a German-based regulatory consulting firm serving small and medium-sized medical device manufacturers seeking EU market entry. Founded in 2000, the family-owned firm provides EU Authorized Representative services, CE Marking support, and related MDR/IVDR compliance services.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

Keywords

• Medical device regulatory consulting
• CE marking services
• EU authorized representative
• MDR IVDR compliance
• Medical device registration

Headquarters

HQ city

Langenhagen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Revenue generated through professional consulting fees for regulatory affairs services including EU Authorized Representative services, CE Marking consulting, technical documentation compilation, and regulatory compliance support for medical device manufacturers under MDR (EU) 2017/745 and IVDR (EU) 2017/746.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

MDI Europa provides regulatory consulting and representation services that enable medical device and in vitro diagnostic manufacturers to access the European market. Its core offerings include acting as the European Authorized Representative under MDR (EU) 2017/745 and IVDR (EU) 2017/746, guiding manufacturers through CE Marking registration, and serving as their EU Importer to verify distribution-chain compliance. The firm supplements these core services with Swiss Authorized Representative and UK Responsible Person roles, technical file compilation, declaration of conformity preparation, certificates of free sale, and specialized CE consulting for electrical and environmental requirements.

Product overview

MDI Europa offers a comprehensive suite of regulatory consulting services for medical device manufacturers seeking EU market entry. The core offering consists of European Authorized Representative services under MDR and IVDR, CE Marking support, and EU Importer services. The company provides specialized add-on services for UK and Swiss market access through UK Responsible Person and Swiss Authorized Representative roles. Supporting consulting services include Technical File Compilation, Declaration of Conformity preparation, Certificates of Free Sale, OEM/Private Labeling guidance, and specialized CE Consulting for electrical equipment (EMC/LVD) and environmental requirements (WEEE/RoHS). The company also maintains an Online Library with regulatory resources and provides monthly news updates and newsletters on regulatory developments. MDI Europa targets small and medium-sized enterprises (SMEs) and was founded in 2000.

Differentiator

Problem solved

Functional benefit

Products and services

• European Authorized Representative Services
• CE Marking Services
• EU Importer Services

Quantifiable outcome

• Hundreds of medical device manufacturers successfully registered for CE Marking with European competent authorities

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Two partnerships are on record, tiered core and minor.

• mdi Consultants (United States)coreStrategic or Co-development Partner · 1 January 2000Founding partner relationship established when mdi Europa was set up as an affiliate but independently operating partner of mdi Consultants in the United States, representing a transatlantic regulatory affairs network.
• RegulanetminorStrategic or Co-development PartnerRegulanet is referenced as a partner organization, suggesting a network or alliance of regulatory affairs consultants at the European level.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Emergo by UL: Global regulatory consultancy (acquired by UL) offering EU AR, CE Marking, and worldwide market access services for medical devices — broader portfolio, larger headcount, and a more established brand competing in the same AR space.
• TÜV SÜD Product Service: Large global notified body and testing/certification giant offering CE Marking audits and regulatory support — competes more broadly across the medical device compliance value chain rather than specializing in AR services.
• BSI Group: Major notified body and certification provider for medical devices under MDR/IVDR — adjacent rather than directly competing, but represents the larger institutional end of the EU medical device regulatory ecosystem.

Direct peers

• Advena Ltd: Malta-based EU Authorized Representative and Person Responsible for Regulatory Compliance (PRRC) services for medical device manufacturers — directly comparable AR-focused service model.
• RQM+ (formerly R&Q): Global medical device regulatory and quality consulting firm offering EU AR services, CE Marking, technical file review, and clinical evaluation — comparable service portfolio and customer base, with broader geographic reach and larger headcount.
• I3C GmbH: Germany-based EU Authorized Representative for medical device and IVD manufacturers — a small, specialist AR provider competing for the same non-EU SME customer base.
• MedPass International: France-based EU Authorized Representative and medical device regulatory consultancy serving non-EU manufacturers — directly competes in the same AR and CE Marking service category across the EU market.
• Medidee Services: Swiss-headquartered medical device regulatory, clinical, and quality consulting firm providing CE Marking, EU AR, and MDR/IVDR services — direct comparable in regulatory niche with broader clinical/scientific capability.
• Qserve Group: European medical device regulatory and quality consulting firm offering CE Marking, clinical evaluation, and Authorized Representation services to manufacturers seeking EU market access — directly competing with MDI Europa in the same SME-focused niche.
• Johner Institut: Germany-based medical device regulatory affairs and quality management consultancy providing CE Marking, technical documentation, and MDR/IVDR compliance support to SMEs — directly comparable in geography, customer segment, and service mix.

Market position

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/mdi-europa-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 MDI Europa