Your Gateway to the EU Market for Medical Devices – EU Authorized Representative

Are you a non-EU medical device manufacturer looking to enter the European market? 

 

Compliance with the EU Medical Device Regulation (MDR) requires appointing a European Authorized Representative (EU Rep). Evoleen provides tailored EU Rep services tailored to ensure your compliance and market readiness. 

As your regulatory liaison, the EU Rep is essential for meeting MDR requirements and accessing the EU market. 

Partner with Evoleen today!

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Who are we?

We are a Germany-based team of regulatory experts specializing in serving digital health and med-tech innovators. As your European Authorized Representative (EC-Rep), we bridge the gap between your medical device and the EU market by ensuring compliance with the Medical Device Regulation (MDR). Our mission is to empower startups and small businesses to scale globally with ease and confidence.

Under the MDR (Regulation (EU) 2017/745), non-EU-based manufacturers must appoint a European Authorized Representative (EU Rep) to place medical devices on the EU market. 

The EU Rep plays a critical role, including:

  • Ensuring Compliance: Verifying technical documentation and conformity assessments (Article 11(3)(a)). 
  • Liaising with Authorities: Acting as a point of contact for EU Competent Authorities during inspections or incidents (Article 11(3)(b)). 
  • Incident Reporting: Handling serious incidents and ensuring post-market surveillance (Article 11(3)(d)). 
  • Labeling Requirements: Ensuring your devices are labeled with the EU Rep’s contact details (Article 11(3)(e)). 

Evoleen combines expertise, agility, and an extensive network to offer unmatched EU Rep services. Here’s why we’re the right partner for your business: 

  1. Lean & Efficient

    Our streamlined approach ensures compliance without unnecessary complexity, saving you time and resources.

  2. Experienced & Capable

    With years of experience in medical device regulations, we’ve successfully guided numerous manufacturers into the EU market.

  3. Strong Regulatory Connections

    Our established relationships with regulators and industry service providers across Europe and beyond mean smoother processes and faster resolutions. 

implementing robust quality systems and certifying medical devices/software solutions​

streamlining complex regulatory processes​

orchestrating successful clinical studies

Compliance made simple, so you can focus on innovation

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