Your Trusted Partner for Global Regulatory Compliance

We offer representation and support to access the EU, UK, US & Swiss markets

News & Webinars

26 September 2024: last call for manufacturers of legacy devices

Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.

Extended IVDR legacy period officially published

On 9 July 2024, the Official Journal of the EU published Regulation (EU) 2024/1860, amending the medical devices Regulations (MDR and IVDR). This introduces an extended legacy period for IVDs, effective immediately.

How to carry out clinical investigations of medical devices in the EU

To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.

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Our Territories

Europe
United Kingdom
United States
Switzerland

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Medical Devices
In-Vitro Diagnostics
Cosmetics
Other Products
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EU & Swiss EC REP
EU & UK RP
US Agent
Consultancy
Product Registration
(or view all)

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.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us

Experience

Founded in 1988, we are among Europe’s largest centres for advisory and representative services.

ISO Certification

We are certified by ISO 9001:2015 and ISO 13485:2016.

Commitment to Compliance

We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.

Proximity to EU Institutions

We are members of professional associations and more than 10 European Commission working groups.

International Network

Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.

Awards & recognition

Great Place to Work Certification 2023

Certified employee satisfaction and workplace culture

Trends Gazelle Award 2022

Fastest growing medium-sized company in Belgium on the basis of value, employee and cash flow growth

Trends Gazelle Award 2023

Obelis win a second Trends Gazelle award moving from medium-sized to big enterprise category

Our Team

Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.

Presence & Network

Our Brussels headquarters is located within walking distance of the European Commission.

Regional branches allow us to effectively serve markets in the United Kingdom, Switzerland and Israel as well.

In addition, we also benefit from a tight network of independent international partners, the Obelis International Offices (OIO).

View our partners

Become a partner

Obelis Group

Obelis EU

Obelis UK

Obelis US

Obelis Switzerland

Obelis Israel

SYNC Projects

Information Platform: Cosmetics

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

It’s the perfect tool that allows manufacturers to stay informed about regulatory requirements and changes to ensure compliance is met and maintained.

Explore COSlaw.eu

Information Platform: Healthcare

MDlaw.eu is our regulatory information platform on medical devices and in-vitro diagnostics. This indispensable tool for manufacturers, which lists all documents on the MDR and IVDR in one place, allows manufacturers stay up to date about the latest regulatory requirements.

Explore MDlaw.eu

Information Platform: Other Industries

PRODlaw.eu is the information platform on European law about construction products, electronics, general safety products, machinery, motor vehicles, marine equipment, pressure equipment, personal protective equipment, equipment for potentially explosive atmospheres, and toys.

Explore PRODlaw.eu

Careers

At Obelis, each employee creates a difference and makes an impact. This is why for us, employee satisfaction comes before client satisfaction.

Our certification by the Great Place to Work Survey 2022-23 proves it. Find the career that suits your passion and purpose and join us! #WeAreObelis

Careers and open positions