European Representative for non-EU medical device manufacturers
Comply with European regulations and market your medical devices in the European Union with total safety and legal backing.
What is this service?
If your company manufactures medical devices outside the European Union, you need an Authorized Representative in Europe to market them legally.
We offer a comprehensive service as a European Authorized Representative (EAR), acting as your official liaison with European health authorities and ensuring compliance with Regulation (EU) 2017/745 (MDR).
What is included?
As your European authorized representatives, we handle:
- Acting as the official contact point for competent authorities in the EU
- Verifying that technical documentation complies with current regulations
- Keeping documentation available for regulatory inspections
- Collaborating in incident management and post-market surveillance
- Ensuring the correct identification of the representative on the product labeling
Key Benefits
Avoids regulatory blocks, sanctions, or commercialization issues. Having a European representative is not optional: it is an essential requirement.
We ensure that your product can enter and remain in the European market with full guarantees.
Who is it for?
This service is designed for:
- Medical device manufacturers located outside the EU
- Companies wishing to access the European market legally
- Businesses that need to outsource European regulatory compliance