Global Regulatory Compliance

Your Authorized Representative & Responsible Person

At Obelis, we specialize in ensuring regulatory compliance for Medical Devices, Cosmetics, and other industries. 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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Industries

Services

EU Authorised Representative (EC REP)

To sell medical devices and IVDs, non-EU manufacturers must have an EU Authorised Representative (EC REP).

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EU Responsible Person (RP)

To sell cosmetics in the European Union, brand-owners must appoint an EU Responsible Person (RP).

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US Agent

MoCRA establishes that facilities based outside the United States must have an in-country representative: a US Agent.

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Consultancy

For all manufacturers and brand-owners, we offer consultancy services to guide you through the applicable regulatory requirements.

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Swiss Authorized Representative (CH REP)

All non-Swiss manufacturers must designate a Swiss Authorised Representative (CH REP) to sell their medical devices in Switzerland.

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UK Responsible Person (UKRP)

You can appoint us as your UK Responsible Person (UK RP) for different products, such as medical devices.

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Product Registration

Depending on the applicable legislation, we perform a product registration or notification to access the EU, UK, and Swiss market.

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Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

  • Europe’s leading center for regulatory consultancy and representative services
  • ISO 9001:2015 and ISO 13485:2016 certified
  • Since 1988, we supported 3,000+ manufacturers from 60+ countries
  • Members of professional associations and European Commission working groups
About us
European Union
Switzerland
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Events and webinars

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Databases

Cosmetics

COSlaw.eu is our all-in-one information platform on European cosmetics law.

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Healthcare

MDlaw.eu is our information platform on medical devices and in-vitro diagnostics.

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Other Industries

PRODlaw.eu is the information platform on European law about all other products.

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What clients are saying

Proud member of key professional organisations

Start your compliance journey with Obelis.