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
- More than 30 years of business experience
- Located in Belgium, Brussels at the heart of European Union
- The largest consultancy centre in Europe
- Strong international presence supporting your business in 18 global markets across the world
- Dedicated team of Experts ready to support you (Lawyers, Chemists, Pharmacists, Researcher, Scientists and others)
- Helped more than 3,000 companies over 70 countries to sell their products on the European market
- MDR & IVDR Consultants
- UK Representative
- ISO 9001 & ISO 13485 Certified
- Active member of EU Associations and EU Commission Committees and Working Groups
- Chairman and Founder of European Association of Authorized Representatives (E.A.A.R.)
- Co-founder of the European Responsible Person Association (E.R.P.A.)
- Organizer of international seminars, workshops & webinars in cooperation with Experts worldwide
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
- Covid-19 IVD Test Kits – Swab Compliance
- The UK market after Brexit - The end of grace periods for registering your MDD&IVDs and Cosmetics is approaching quickly
- New ISO standard available for COVID Ventilator
- European standardisation for 2021. An overview of relevant objectives and policies.
- Allergenic fragrances in cosmetics sold as “perfume-free”: the EDQM report
- Toy safety: the EU moves to protect children from potentially allergenic fragrances in toys