Medical Devices → European Union

Compliance for Medical Devices in the European Union

Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Switzerland, and beyond to support your compliance needs effectively.

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Authorised Representative (EAR)

CE Marking Guidance

Technical File Review

EUDAMED Registration

Free Sales Certificate

Notified Body Application

GMDN and EMDN Codes Research

Clinical Investigation Legal Representation

Interruption of Supply Notification

Quality Management System Support

Consultancy for Medical Devices

Legal Services

Trademark Registration

GDPR Compliance

Regulatory Content Creation

MDlaw.eu is the internet's most extensive information platform on medical device law.

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Other Regions

Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

United States

The United States is the world’s largest and most lucrative medical device market, offering vast opportunities but demanding rigorous FDA compliance for market entry. 

United Kingdom

The United Kingdom’s medical device market remains a key opportunity post-Brexit, but requires navigating its own regulatory framework, including UK-specific compliance for market access. 

Switzerland

Switzerland’s medical device market is innovation-driven and closely aligned with EU standards, but requires non-Swiss manufacturers to meet national obligations. 

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