EU Authorized Representative
EU Authorized Representative (EU REP) for Medical Device Manufacturers
Planning to sell medical devices in the EU?
If your company is established outside the EU and wants to place medical devices — including disposable gloves classified as medical devices — on the European market, the EU Medical Device Regulation (MDR (EU) 2017/745) requires you to appoint an Authorised Representative (EU REP) established in the EU.
Your EU REP acts as your legal point of contact with EU authorities. This includes verifying your technical documentation, handling regulatory inquiries, managing complaints and incident reporting (vigilance), and ensuring registration in EUDAMED.
QA MED Solutions is a Danish consultancy with strong experience in MDR, ISO 13485, and regulatory compliance for medical devices. We are currently building out our EU REP service to offer non-EU manufacturers a competent, reliable, and well-founded route into the European market.
Invitation for an introductory talk with us
We are currently having introductory conversations with manufacturers who want to prepare for a future EU REP agreement with us.
Send an email to info@qamed.dk with your company name, country, and a brief description of your product(s), and we’ll get back to you with an invitation to an introductory talk.
How a partnership with us as your
EU Authorized Representative typically works:
Step 1 — Introductory meeting
We get to know each other: your products, your current market presence, and your existing technical documentation.
Step 2 — Gap assessment
We review your documentation against MDR requirements and identify what needs to be in place before we can act as your EU REP. Together we agree on scope and next steps.
Step 3 — Ongoing collaboration
Once the agreement is in place, we work together on a regular basis (for example, monthly check-ins) to keep documentation, vigilance, and EUDAMED registration up to date — much like our ongoing PRRC partnerships with existing clients.
Invitation for an introductory talk with us
We are currently having introductory conversations with manufacturers who want to prepare for a future EU REP agreement with us.
Send an email to info@qamed.dk with your company name, country, and a brief description of your product(s), and we’ll get back to you with an invitation to an introductory talk.
