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

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Medical devices

In-vitro diagnostics

Cosmetics

Other products

Food supplements

Services

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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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Trainings

For all manufacturers and brand-owners, we offer training services to help you navigate the EU regulatory landscape.

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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

years in business

clients from

countries

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

“I encourage companies to seek compliance before putting their devices on the market.Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company”

Ran Amos VP of Quality Assurance & Regulatory Affairs at Samsara Vision

“Obelis helped us navigate complex regulatory landscapes, ensuring we met all legal and industry-specific obligations. Obelis deeply understands the cosmetic regulatory landscape and they have provided all the necessary support”

Terry Luu Chemist at Home and Body Co.

“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications”