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Obelis GROUP

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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

07/01/2026

EUDAMED registration becomes mandatory for actors and medical devices under the MDR and IVDR, with no room for last-minute preparation ‼️.

Missing the deadlines can mean market access delays or loss of EU availability. Understanding the timelines and acting early is now essential.

👉 Follow Obelis Group for clear EU regulatory insights
👉 Start preparing now to stay compliant in 2026

05/01/2026

2026 is a turning point for regulatory compliance. 🎯
Mandatory databases, tighter deadlines, global cosmetics safety requirements and AI-driven services are reshaping how companies access the market.

At Obelis Group, we turn complexity into clarity so our clients can stay compliant, competitive, and focused on what truly matters: bringing safe products to market.

Partner with us and navigate regulatory change with confidence!
👉 Follow us to stay informed, prepared, and always one step ahead.

30/12/2025

What a year. 🎉 Here’s our 2025 recap, a carousel of our favourite moments, proudest wins, and the milestones that shaped Obelis this year.

And that’s not even everything. Beyond what you’ll see in the slides, we also:
✨ launched a new Obelis Group website design & structure
☁️ became a fully cloud-operated organization
🚀 made a 25% investment in system innovation
🤖 accelerated process automation + AI
🎉 and celebrated 37 years in business

Thank you to our team, partners, and clients for making 2025 unforgettable. We're excited for what's coming next. 🙌

24/12/2025

From all of us at Obelis, we wish you holidays filled with peace, gratitude, and fresh inspiration for the year ahead ✨💙

Thank you for letting us be part of your journey to bring safe, compliant products to people’s lives. In 2026, we’ll be right by your side helping you turn bold ideas into trusted realities. 🌟

16/12/2025

Another year at the International Cosmetic Congress in Antalya ✨ and this time, together with our colleagues from Obelis Türkiye🤝

A big highlight: we hosted a highly successful workshop about Cosmetic Regulation, where our experts shared valuable insights to help industry professionals navigate the ever-evolving regulatory landscape. ✅

We’re also here to share our knowledge on the key regulatory trends shaping 2026 and what brands should start preparing for now so if you are around, come meet us!

11/12/2025

Thinking MoCRA compliance = green light for California? Not quite. 👀

California adds an extra layer of rules on top of US federal law and they focus heavily on ingredients, warnings & formulas.

If your products are sold (or will be sold) in California, this is essential for staying on shelves.

👉 Swipe through to see what each law means for your formulas & labels, and save this post for your next US compliance check.

📩 Need support with MoCRA and California-specific rules? Obelis can help you review formulas, labels and reporting duties.

09/12/2025

We’re introducing our new Swissdamed Device Registration service 🚀

Switzerland’s new medical device database (Swissdamed, under MedDO & IvDO) is already open on a voluntary basis but device registration will become mandatory from 1 July 2026 (with a transition until 31 December 2026).

If you’re a non-Swiss manufacturer, you can’t access the portal directly, your Swiss Authorised Representative must do it for you.

As your Swiss AR, Obelis will handle your Swissdamed device registrations end to end so you’re ready well before the deadline. 💼✨

04/12/2025

New rules for construction products are coming to the EU… and they’re BIG.🙌

From January 2026, under Regulation (EU) 2024/3110, non-EU manufacturers of construction products (including 3D-printed items and kits) will need to appoint a European Authorised Representative (EAR) to place their products on the EU market.

Your EAR will:
🔹 Keep technical documentation & declarations available for authorities
🔹 Cooperate with market surveillance
🔹 Alert you & authorities if a product is non-compliant or poses a risk
🔹 Verify that you, as manufacturer, fulfil your CPR obligations

The regulation will roll out gradually with complex transitional periods extending up to 2040 so early planning is essential.

📩 Not sure how affects your products?
Contact Obelis to assess your obligations and set up your EAR mandate in time.

01/12/2025

Tea Tree Oil and CBD are having their moment with EU regulators. 🔍

The SCCS has just issued new opinions on several cosmetic ingredients, including Tea Tree Oil, CBD, BHA, certain hair dyes and mercury-based preservatives, clarifying when and how they can be safely used in cosmetics.

If you work with cosmetic formulas, this isn’t “nice-to-know”, it’s need-to-know for keeping your products compliant in the EU.

👉 Swipe through to see the key takeaways, and save this post for your next formula review.

27/11/2025

EUDAMED is switching on, are you ready? ⚙️✨

The European Commission has just confirmed that 4 key EUDAMED modules are now fully functional:
• Registration of economic operators
• UDI & device registration
• Notified bodies & certificates
• Market surveillance

This is a major step towards full MDR/IVDR implementation, increasing transparency, traceability, and responsibilities for all actors in the supply chain.

As your EU partner, Obelis Group helps you:
✅ Prepare and structure your UDI & device data
✅ Register your economic operator details
✅ Keep certificates and documentation up to date
✅ Stay ahead of upcoming EUDAMED obligations

25/11/2025

What a week at MEDICA! 💙

It was a pleasure meeting so many of our clients face to face and talking about their next steps in EU, UK, US & Swiss market access.
📸 Swipe through to see some highlights and familiar faces from the event!

19/11/2025

🔋 Does your device contain a battery? Then this regulation concerns you.

From headphones to high-risk medical devices, if it has a battery and you place it on the EU market, Regulation (EU) 2023/1542 brings new obligations and extra scrutiny.

That’s where we step in.

✨ Obelis now offers a dedicated European Authorised Representative (EAR) for Batteries), covering all products that include batteries, including medical devices.

With Obelis as your EAR, you get:
✅ An EU-based legal representative for batteries and battery-powered devices
✅ A single contact point for EU authorities and market surveillance
✅ Guidance on labelling, documentation & information duties under the new Batteries Regulation
✅ Harmonised compliance across your entire battery-powered portfolio

Don't let battery rules disrupt your EU market access.
👉 Appoint Obelis as your EU EAR for Batteries and stay ahead of Regulation (EU) 2023/1542.

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/

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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.