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 structure, which they state safeguards flexibility and efficient pricing, while ensuring continuing reliable guidance through a single point of contact for all processes. They highlight their ability to provide excellent regulatory services globally. The company also notes its extensive network of regulatory experts worldwide, enabling them to assist a broad range of clients, from start-ups to established corporations. Their client testimonials suggest a high level of responsiveness and expertise in EU Authorized Representative roles, with a consistent mention of valuable monthly newsletters.

Key Highlights

  • Founded in March 2000, providing over two decades of experience in medical device 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 to assist clients to comply with EU legislation.”
  • Specializes in EU Authorized Representation and CE Marking for medical device manufacturers. Source
    “mdi Europa GmbH acts as European Authorized Representative for a wide range of companies”
  • Assists with compliance for both the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Source
    “(As defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR))”
  • 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.”

Certifications & Trust Signals

  • Established in March 2000, indicating long-term presence and experience in the field. Source
    “mdi Europa GmbH was founded in March 2000”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking EU Authorized Representation.
  • Companies needing assistance with CE Marking and regulatory compliance.
  • Startups and established corporations navigating EU medical device regulations.
How engagement typically works
  • Dedicated single point of contact for all processes.
  • Flexible and efficient service packages.
  • Responsive communication with quick email responses.
Typical deliverables
  • CE Marking certification support
  • EU Authorized Representative services
  • Technical documentation compilation
  • Declaration of Conformity
  • Certificates of Free Sale
Good to know
  • Best when requiring specialized regulatory expertise for the EU market.
HQ: Langenhagen, Germany
Languages: English, German
Timezones: Europe/Berlin
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

Additional importer_distributor_compliance Details

Role Coverage
Importer, Distributor, Authorized Representative, importer
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Storage Conditions Support
No
Onboarding Steps
The website mentions that clients receive continuing reliable guidance by one contact person throughout all processes, implying a structured onboarding and ongoing support system.
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