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Obelis GROUP

Name: Obelis GROUP
Address: Boulevard Brand Whitlock 30, Brussels, 1200, BE
Telephone: +3227325954
Rating: 3.6

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België
Brussels
Obelis GROUP

Since 1988 Obelis is assisting non-EU manufacturers’ successful endeavour into Europe. www.obelis.net.

Obelis European Authorized Representatives Center (O.E.A.R.C.) & European Responsible Person Center (O.E.R.P.C.) is a quality driven, service oriented company with over 20 years of experience with European Regulation. Obelis operates as one of the largest regulatory centers in Europe today, providing CE marking & Authorized Representative services for Medical Devices, In-Vitro Diagnostics as well

as “EU Responsible Person” and Cosmetic Notification services in Europe. While still retaining a special expertise in Medical Devices & Cosmetics, Obelis services cover most of the NEW Approach European Directives (Directives requiring either a CE marking or authorized representative – such as medical devices, in-vitro diagnostics, machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, cosmetics, toys and many more). Obelis is a veteran member of the E.A.A.R ( the European Association of Authorized Representatives).Obelis is active within the EU commission major committees (Medical Device Vigilance committee and IVD Technical committee, Cosmetic Annex I Committee and more) - providing its clients and collaborators with the directions of the Commission before hand. Specialties
Medical Devices, In-Vitro Diagnostics, Cosmetics, Authorized Representative / Responsible Person

30/06/2025

🌍 Looking to bring your cosmetic products to the EU market?

Before you ship that serum or launch that lotion, make sure you're compliant!

Our Article of the Month breaks down everything you need to know to successfully enter the EU cosmetic market, from regulatory must-haves to your role as a Responsible Person.

📖 Read the full article here 👉 https://www.obelis.net/news/eu-cosmetic-compliance-guide-to-entering-the-eu-market/

25/06/2025

🔍 Medical Device Classification Matters!

Understanding how your device is classified under EU MDR/IVDR or UK Medical Regulations is key to choosing the right regulation pathway and avoiding costly delays.

📊 Did you know that software used for diagnosis often qualifies as Class IIa or higher?
Or that Digital Mental Health Technologies may count as medical devices in the UK?

Knowing your classification = safer, faster, and more compliant market access.

24/06/2025

🌟 Meet Obelis at ADLM 2025

We will be at the Association for Diagnostics & Laboratory Medicine exhibition and we are eager to meet innovative medical devices companies and discuss how to navigate the complex world of regulatory compliance.

If you're looking to achieve compliance in the EU, UK, US or Switzerland, let's connect!

Our experts Dimitris Kallianis and Simona Varrella will be on-site, ready to:
✅ Share tailored advice for your regulatory challenges
✅ Help you map out a clear compliance pathway
✅ Keep you ahead of evolving market requirements

Book a meeting with us now! https://forms.zohopublic.eu/obelisgroup/form/BookameetingatADMLChicago2025/formperma/TTILTULGJbRmpJpQ-6oD5vMhgy_TBH9qA7GQJ6fXcjI

Let’s make sure your medical devices are ready for global success. See you in Chicago! ✈️🩺

17/06/2025

🌟 We’re heading to Cosmoprof North America – Las Vegas!

If you're a cosmetic brand eager to expand to the EU, UK, US or Canada, let's connect.

At Obelis, we specialize in helping brands like yours navigate complex regulations, ensure product compliance, and confidently enter new markets.

Want to meet up?
Book a meeting with us at Cosmoprof to:
✅ Get expert advice on your regulatory challenges
✅ Build a clear compliance roadmap for your products
✅ Stay ahead of the latest legal requirements

🔗 Spots are limited: https://zfrmz.eu/8tpZ8B6j5Q0VjUhSijn2

Let’s make sure your cosmetics stand out on shelves worldwide, safely and compliantly. See you in Vegas! ✈️✨

11/06/2025

🚨 From June 16, 2025, all medical devices sold in Great Britain must comply with new Post-Market Surveillance (PMS) requirements.

Why does it matters? Because it's all about enhancing patient safety and ensure more rigorous oversight of medical devices.

✅ Mandatory PMS Plan → Every manufacturer needs a clear strategy for data collection, analysis, reporting, and corrective actions.

✅ Stronger Reporting Duties → Device class now determines whether you submit PMS Reports or Safety Update Reports to MHRA.

✅ Faster Vigilance Actions → Manufacturers and UK Responsible Persons must act quickly on incidents and corrective measures.

✅ Clearer Definitions → Terms like serious incident and lifetime now have sharper, standardized meanings.

Heads-up! Even if you're using CE/UKCA-marked devices, MHRA recommends aligning with these new standards.

Let’s make compliance a driver for better, safer healthcare! 💪

26/05/2025

We're heading to NYSCC Supplier's Day! 🎉

Next week, you can meet our amazing team at the New York Society of Cosmetic Chemists , come visit us at booth number 1981!

Want to chat? Don’t wait, book a meeting with us now! https://forms.zohopublic.eu/obelisgroup/form/BookameetingatNYSCC2025/formperma/-CHT4zVg9O-qEADHypgtS97NuC-IlWogUYN4lkGFNvc

👋 Say hi to Shikha Malhotra, Chiara Lai, and Geoff Waby. They’ll be representing us at the event and are excited to connect!

21/05/2025

📢 Meet Us at WHX Miami!

From June 11–13, our team of regulatory compliance experts will be attending WHX Miami (formerly FIME), and we can't wait to connect with the innovators driving the future of the medical device industry.

🌍 Whether you're developing cutting-edge tech or expanding to new markets, we’re here to guide you through regulatory compliance in the EU, UK, US, and Switzerland.

📅 Let’s meet in Miami! Schedule a one-on-one with our team: https://forms.zohopublic.eu/obelisgroup/form/BookameetingatFIMEMiami2025/formperma/V1KB_YiwMUd1HlJb0L6-XdCZZGR03BAK6fuzEHomtAs

15/05/2025

🌍 Are Science and Beauty your world? Let’s meet at NYSCC 2025!

We will be exhibiting on booth number 1982. Whether you're developing the next skincare breakthrough or launching innovative beauty solutions, we’re here to help your brand thrive in a globally regulated market.

✅ Compliance & market access strategies
✅ Faster approvals
✅ Latest regulatory updates

Book a meeting with us today 👉 https://zurl.co/0gFua

12/05/2025

✨ That’s a wrap on Beauty Istanbul! ✨

Our regulatory experts were on the ground meeting amazing clients, discovering bold new brands, and diving into the latest in beauty innovation.

If you're launching cosmetic products and need help with regulatory compliance, we're here to guide you, from concept to market. Let's make your brand shine! 💬📩

28/04/2025

⏳ The clock is ticking for the May 2025 Cosmetics Ban Deadline!

Are you ready for the new regulatory changes that could impact your products in the EU market? 🚨Discover what’s banned, what’s changing, and how you can stay compliant.

👉 Read the full article here: https://www.obelis.net/news/may-2025-comsetics-ban-deadline/

Adres

Boulevard Brand Whitlock 30
Brussels
1200

Openingstijden

Maandag	09:00 - 18:00
Dinsdag	09:00 - 18:00
Woensdag	09:00 - 18:00
Donderdag	09:00 - 18:00
Vrijdag	09:00 - 18:00

Telefoon

+3227325954

Website

http://www.obelis.net/

Meldingen

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Contact

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Obelis Story

We are Obelis.

Obelis Group is a leading specialist in European regulatory, directive, and compliance strategy. Its comprehensive CE marking, responsible person, authorized representative, and consultancy services have helped countless European and non-European manufacturers alike introduce their products successfully to the EU market in full compliance with all regulatory standards and requirements.

Founded in 1998, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe. It is also a veteran member of the EAAR (European Association of Authorized Representatives) and a founding member of the ERPA (European Cosmetics Responsible Person Association).

Its specialization in the last 30 years has been crucial in proliferating safe, harmonized standards and compliance in the European community, shepherding countless quality products onto the EU market in full regulatory compliance.

Full European Compliance

Obelis’ services and expertise covers a majority of the New Approach European Directives (those making CE marking or an authorized representative mandatory for a product). Through its extensive work in the area, Obelis has become a market expert in CE marking and regulatory compliance for machinery, personal protective equipment, pressure equipment, radio and telecommunications equipment, electrical equipment, low voltage equipment, and toys, with a strong emphasis on cosmetics and medical and in-vitro devices.

Medical & In-Vitro Devices

As an EU leader in healthcare device regulation, Obelis offers full authorized representative services as well as consultancy and guidance on: technical file creation and review, market notification and vigilance, product classification, sales certification, identification of standards and essential requirements, risk management, CE marking, clinical evidence, and trade mark submissions. Obelis’ regularly updated platform for EU MDR and IVDR information, MDLaw.eu, is a key resource for all industry bodies, from manufactures to third-party distributors.

Cosmetics

Similarly, Obelis’ activity in the European cosmetics industry runs deep, allowing it to offer quality European responsible person services including: file verification, testing guidance, labelling review, product market notification, cosmeto-vigilance, market updates and consultancy, claim research and validation, nano-material notification, sales certification, and team training on key compliance areas.