Your Trusted Partner for Global Regulatory Compliance
Your In-Country Representative For Medical Device Compliance in the EU, UK, CH & US
We support manufacturers of Medical Devices and IVDs with one-stop shop solutions for compliance
IVDs need a Notified Body appointed by 26 May 2026
Do not risk non-compliance!
Why Obelis?
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.
Our Team
Our team consists of lawyers, chemists, pharmacists, and other experts.
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Obelis Group
Boulevard Brand Whitlock 30,
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
sales@obelis.net
© Obelis Group 2026
EU, UK, CH, US
- Authorised Representation (EC REP)/ Responsible Person (UK RP)
- EUDAMED device and actor registration
- Device registrations to the EU & UK authorities (MHRA)
- MedDO/ IvDO & MDR/ IVDR technical documentation review
- Assist with CE & UKCA marking
- Vigilance and incidence reporting
- MDlaw.eu news, alerts, templates and guidelines
- Compliance trainings
Client Success stories
The EUDAMED verification and mandate update were completed successfully, allowing us to maintain our devices on the EU market without any regulatory issues or interruptions. The process was efficient and well managed.
We successfully maintained our EU market access
Biobeat Technologies Ltd.
With Obelis’ support, our device was successfully registered on the MHRA portal. We’re now ready to place our product on the UK market with full confidence. Without their guidance, the process would have been far more stressful and prone to delays.
We're now ready to place our product on the UK market with confidence
Koravie Limited
Obelis brought the clarity we needed. Their in-depth regulatory knowledge and ability to act swiftly made a real difference. They weren’t just service providers, they were collaborators.
Obelsi brought the clarity we needed when it mattered most
Medical Devices (Pvt) Ltd.
We register your products in the EU, UK and Switzerland in 3 working days