Covid-19:Teleworking & Counterfeit Certificates
Obelis has decided to implement #teleworking in order to minimize the potential health risk to its personnel.
During the coronavirus crisis we became aware of several attempts to counterfeit notification certificates issued by Obelis.Learn more
Together against COVID-19!
We are proud to empower Chinese manufacturers to truly make a difference by rapidly notifying hand sanitizers, face masks, gloves, protective coveralls and eyewear protection on the European market.Read more
Are you MDR/ IVDR compliant?
Obelis endorses the information platform MDlaw.eu!
Find all Medical Device Regulations (MDR & IVDR) related documents: official guidelines, templates, news and updates – all in 1 place.Become a Member
Your Consultant on EU Regulations
We support your product launch to the EU Market through documentation review, product registration and legal representation. SERVICES
Our support is managed by our Quality System which is certified ISO 9001 & 13485. TESTIMONIALS
Our team is comprised of Lawyers, Chemists, Pharmacists and Regulatory Experts with several decades of experience in EU affairs. ABOUT US
Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the entire community.Learn More
For your products to legally enter the EU Market and continue to circulate, you must have valid documentation.Learn More
- Since 1988
- Established in Belgium, Brussels
- The largest consultancy centre in Europe
- Solid international reputation
- Dedicated team of Experts ready to support you (Lawyers, Chemists, Pharmacists, Researcher, Scientists and others)
- Qualified & knowledgeable personnel
- Strong international presence
- Certified ISO 9001 & ISO 13485
- Active member of EU Associations and EU Commission Committees and Working Groups
- Chairman and Founder of E.A.A.R. (European Association of Authorized Representatives)
- Well-known organizer of international Seminars & Workshops (www.obelisacademy.com ) in cooperation with Authorities worldwide
- Strong network able to provide Obelis Clients with local regulatory solutions in 20+ markets worldwide
- Broad spectrum of services
Obelis is the sixth consulting firm we have worked with and NONE can compare with the professionalism and knowledge your team exhibits.
Obelis is the Gold standard of EU Responsible Person's for brand owners in looking to successfully enter the EU Market
- Faster access of IVDs on the French market
- AEMPS Information about market campaign control for sunscreen products
- UK’s Guidance on 3D printing of medical devices or component parts during the pandemic
- Labeling guidance for hydroalcoholic gels published by the Spanish Agency of Medicines and Medical Device (AEMPS)
- National MDR implementation – Germany’s establishment of NAKI
- Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks