mdi Europa (EU Importer Services)

mdi Europa GmbH

mdi Europa GmbH is a German-based company specializing in regulatory affairs for medical device manufacturers. They offer services like CE Marking, EU Authorized Representation, and compliance consulting.

Founded in March 2000, mdi Europa GmbH provides flexible and tailored service packages to help medical device manufacturers worldwide comply with EU legislation, including the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). They act as a European Authorized Representative for numerous companies, assisting with CE Marking and registrations with European competent authorities. Their lean structure ensures efficient pricing and reliable guidance from a single point of contact throughout all processes. mdi Europa GmbH offers a comprehensive suite of compliance solutions, including CE Marking, MDR/IVDR compliance, Certificates of Free Sale, OEM/Private Labeling, Technical File Compilation, Declaration of Conformity, and consulting for electrical equipment (EMC/LVD) and environmental requirements (WEEE/RoHS). They pride themselves on their highly qualified regulatory affairs specialists and a global network of experts.

About

**Who they are**
mdi Europa (EU Importer Services) was founded in March 2000 and is a German-based company specializing in regulatory affairs for medical device manufacturers worldwide. They focus on providing flexible and well-adjusted service packages to assist clients in complying with EU legislation.

**Expertise & scope**
* CE Marking and CE Approval
* EU Authorized Representation for manufacturers of medical devices
* MDR (Medical Device Regulation (EU) 2017/745) and IVDR (In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746) compliance
* Technical File Compilation
* Declaration of Conformity
* Certificates of Free Sale
* OEM – Private Labeling
* Consulting for Electrical Equipment (EMC / LVD)
* Consulting for Environmental Requirements (WEEE / RoHS)

**Reputation / proof points**
* Has registered hundreds of medical device manufacturers for CE Marking with European competent authorities.
* Offers lean structure for flexibility and efficient pricing.
* Provides continuing reliable guidance by one contact person throughout all processes.
* Maintains a worldwide network of regulatory experts.

Additional information

mdi Europa emphasizes a lean operational structure, which they state allows for flexibility, efficient pricing, and consistent, reliable guidance through a dedicated point of contact. They have established a worldwide network of regulatory experts to support their clients. The company also highlights its ability to assist clients with various aspects of regulatory compliance, from initial CE Marking to ongoing adherence to EU regulations like MDR and IVDR. Their services are designed to support a range of clients, from emerging startups to established global corporations.

Key Highlights

  • Specializes in EU Authorized Representation for medical device manufacturers. Source
    “mdi Europa GmbH acts as European Authorized Representative for a wide range of companies”
  • Offers comprehensive CE Marking services, including Technical File Compilation and Declaration of Conformity. Source
    “Our high quality compliance solutions include CE Marking, Technical File Compilation, Declaration of Conformity”
  • Supports compliance with both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Source
    “(As defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR))”
  • Founded in March 2000, providing extensive experience in regulatory affairs. Source
    “mdi Europa GmbH was founded in March 2000 to provide medical device manufacturers world-wide with flexible and well-adjusted service packages”

Certifications & Trust Signals

  • Established in March 2000, indicating over two decades of operational experience. Source
    “mdi Europa GmbH was founded in March 2000”
  • Has successfully registered hundreds of medical device manufacturers for CE Marking. Source
    “They have registered hundreds of medical device manufacturers for CE Marking with the European competent authorities.”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking EU regulatory compliance support.
  • Companies needing CE Marking and EU Authorized Representation services.
How engagement typically works
  • Direct, single-point-of-contact guidance.
  • Proactive communication and timely responses.
Typical deliverables
  • CE Marking assistance and registration.
  • EU Authorized Representative services.
  • Technical File Compilation.
  • Declaration of Conformity.
Good to know
  • Best when requiring specialized regulatory affairs support for medical devices within the EU.
HQ: Langenhagen, Germany
Languages: English, German
Timezones: Europe/Berlin
Claim status: Listed

Services & Capabilities

Importer & Distributor Compliance Support

Jurisdictions: EU
Countries: DE, AT, NL
Industries: Medical devices, Healthcare, Distribution
Portfolio: 1-5, 6-25
Onboarding time: 5–21 days
Pricing model: Retainer
Starting from: EUR 1,800
Included services: Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Deliverables: Ongoing retainer
Role Coverage: Importer
Training Available: No
Template Pack Available: No
Training Format: None

Additional importer_distributor_compliance Details

Role Coverage
Importer, Distributor, Authorized Representative, importer, EU Authorized Representative
Device Classes Supported
Not explicitly stated, but services cover MDR/IVDR which implies all classes.
Supports MDR
true
Supports IVDR
true
Verification Support
true
Storage Conditions Support
Not explicitly stated.
Onboarding Steps
Not explicitly stated.
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