Your Trusted Partner in EU Medical Device Compliance
Medunion offers end-to-end regulatory support for medical device manufacturers navigating the complex European market.
Streamline your path to EU market
About us
Medunion S.L. is a Spain‑based regulatory compliance consultancy dedicated to supporting non‑EU medical device and in vitro diagnostic (IVD) manufacturers entering the European market. From our base in Barcelona, we guide companies through EU MDR and IVDR requirements, including conformity assessment, technical documentation, clinical and performance evaluation, post‑market surveillance, and vigilance. As an EU‑based partner, we can also act as your European Authorised Representative, ensuring effective communication with Notified Bodies and competent authorities and helping you place safe, compliant products on the EU market.
What we do
We turn EU regulatory obligations into concrete, actionable steps so you can place and maintain your devices on the European market. Below are our key services, from representation to documentation and product registration and clinical support.
EU Authorised Representative
As your EU-REP, we represent your company to European Competent Authorities, ensuring compliance with MDR/IVDR and maintaining regulatory documentation on your behalf.
Medical Devices Registration
We support device registration processes across EU member states, including Class I notifications and EUDAMED entries.
Technical Documentation
Full support in preparing and reviewing your technical files in accordance with Annex II and III of MDR/IVDR.
CRO Services
Our CRO services help you plan, manage, and execute clinical investigations in the EU under MDR/IVDR, ensuring robust clinical evidence.
Free Sales Certificates
We facilitate the application and legalization process for FSCs, enabling you to export your medical devices worldwide.
Medical Translation
We provide precise medical translations to ensure your regulatory, clinical, and technical documents are clear, accurate, and compliant in every target market.
Your Trusted Partner in Compliance
Why Choose Us
Medunion is a regulatory consulting firm focused on the medical device industry. Our mission is to simplify compliance and streamline market access for medical device manufacturers around the globe.
- Deep expertise in EU regulatory frameworks (MDR/IVDR)
- Fast, reliable communication with EU health authorities
- Multilingual team with regulatory, clinical, and quality backgrounds
- Flexible services tailored to startups, SMEs, and global manufacturerss
Our Clients
We’veregistered thousands of medical products
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You ask, we answer
Medunion S.L. – Guiding Your Medical Devices to the EU Market with Compliance and Representation Excellence.
We support submissions and registrations in major markets, including the EU (MDR/IVDR), USA (FDA), China(CFDA) and many international jurisdictions, depending on your strategy.
We work with a wide range of devices, from low‑risk Class I to high‑risk Class III and IVDs, and tailor our approach to your device’s classification and intended use.
Ideally from the concept or early development stage, so we can define the right regulatory pathway, evidence requirements, and documentation, avoiding rework and delays later.
We typically need your device description and intended use, target markets, current documentation (technical file, QMS status, clinical data), and your timelines and business goals.
Yes. We support first approvals (e.g. CE marking, 510(k), PMA) and also post‑market activities such as PMS/PMCF, vigilance, labeling updates, and quality system improvements.
Ready to explore? Contact us now!
Medunion offers end-to-end regulatory support for medical device manufacturers navigating the complex European market.