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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

24/02/2026

Canada calling? Before you launch your cosmetics in Canada, know the rules that matter and understand Health Canada cosmetic regulations requirements.

👉 Swipe for the must-know FAQs on Canadian cosmetics compliance.

19/02/2026

From wireless earbuds to laptops and smart home devices, the electronics we use every day can interfere with each other or even pose electrical risks if they’re not properly designed and tested.

That’s why the EMC Directive and Low Voltage Directive (LVD) set strict rules before products can enter the EU and UK markets to limit electromagnetic disturbance and ensure an adequate level of electrical safety.

At Obelis, we support manufacturers with EU/UK Authorised Representative services, documentation review and regulatory consultancy to help electronic devices meet these requirements before reaching consumers.

🔎 Curious whether your product falls under EMC or LVD? This might be the right time to review your compliance strategy.

16/02/2026

WHX Dubai is officially over, and we’re back at our headquarters in Belgium.
Last week was packed with great energy: meeting with clients, reconnecting with partners, and taking part in meaningful conversations that are shaping the future of regulatory compliance for medical devices and IVDs.

A big thank you to everyone who took the time to meet with us, we’re looking forward to continuing the discussions and turning ideas into action ✅.

12/02/2026

Quality in medical devices starts with a solid QMS, clear gap assessment, and informed regulatory decisions. ⚙️📊

Swipe to discover how these three elements work together to keep your devices compliant and your processes under control.

09/02/2026

✨ Day 1 at WHX Dubai! ✨

We’re kicking off the event with full energy and excitement. Our team of experts is on the ground, ready to share the latest regulatory updates and key steps for compliance in major markets, including the EU, US, UK, Switzerland, and Canada.

Throughout the event, we’ll also be sharing key insights on the upcoming regulatory deadlines in 2026, helping you anticipate what’s coming and prepare your strategy in advance.

📍 Find us at S5.98

If you’re around, swing by our booth! Come meet the team, ask your questions, discover the latest compliance pathways or simply stop for a chat. We’d love to connect 🙌

05/02/2026

26 May 2026 isn’t “far away” anymore and without a Notified Body application your device could be off the EU market overnight.

Here’s what’s happening right now:
⚠️ Notified Bodies are getting fully booked
⚠️ Manufacturers are rushing to secure contracts
⚠️ Delayed applications = no certification path

Now is the time to:
✅ Apply to a Notified Body before the deadline
✅ Upgrade your QMS to IVDR requirements
✅ Start closing technical documentation gaps

At Obelis Group, we support IVD manufacturers and their EU authorised representatives in navigating IVDR transitions and maintaining market continuity.

📩 Want to make sure you’re 2026-ready? Send us a message.

03/02/2026

2026 is the year EU customs really start knocking on the door of e-commerce imports. 🛃📦

EU customs are stepping up their game, checking more parcels, stopping more products, and saying “no thanks” to anything that doesn’t meet EU rules.
And guess what? Most of the issues come from small online orders.

Whether you’re a brand, seller, or marketplace, staying compliant isn’t just a rule…
It’s the difference between smooth deliveries and border headaches. 😅

At Obelis, we help businesses get their products into the EU the right way: safely, smoothly, and with zero surprises.

Slide into our DMs or reach out via our website 💬🌍

27/01/2026

The EU has adopted a new Toys Regulation, replacing the Toy Safety Directive and raising the bar on chemical safety, traceability, and compliance requirements.

If you place toys on the EU market, now is the time to review your compliance strategy‼️.

👉 At Obelis Group, we act as your EU Authorised Representative, supporting compliance, liaising with authorities, and helping ensure your toys continue to access the EU market smoothly under the new rules.

22/01/2026

Is Türkiye on your expansion list?
The rules may look familiar if you’re used to the EU but key differences can make or break your market entry.

If market expansion is on your radar, getting compliance right from day one makes all the difference.

❤️ Like this if Türkiye is on your roadmap
🔎 Visit our website to explore the full regulatory guide and expert insights

20/01/2026

✅ It's time to prepare for Swiss medical device registration.
With mandatory registration starting 1 July, it's time to gather you technical documentation and prepare for Swissdamed registration.

At Obelis Group we support you end to end, from documentation readiness to handling your Swissdamed registration.

👉 Contact our experts today and secure your Swiss market access in time.

15/01/2026

When it comes to cosmetic compliance, similarities can be misleading.

While Swiss cosmetic rules are closely aligned with the EU, key differences remain. From the absence of pre-market notification to the role of the Swiss Agent and how market surveillance works.

Assuming EU compliance is “enough” can lead to gaps, delays, or unnecessary risks. Understanding where the rules diverge is essential for smooth market access.

👉 Swipe to see the key differences
👉 Follow Obelis Group for clear, practical insights on EU & Swiss compliance

13/01/2026

We're heading to WHX Dubai 2026!

From 9-12 February we will be exhibiting in Dubai to connect with global healthcare innovators, manufacturers and clients.

👉 If you’re attending, come meet our team at the Belgian Pavilion – Booth S5.D98 to discuss regulatory compliance, market access, and what’s next for 2026 and beyond.

You can also book a meeting in advance via our website to secure dedicated time with our experts!

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.