Obelis GROUP

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

🚨 New IVDR Legacy Period Extension 🚨The new Regulation (EU) 2024/1860, published on 9 July 2024, extends the legacy peri...
30/07/2024

🚨 New IVDR Legacy Period Extension 🚨

The new Regulation (EU) 2024/1860, published on 9 July 2024, extends the legacy period for IVDs. Key dates:

🔹Class D: Until 31 Dec 2027

🔹Class C: Until 31 Dec 2028

🔹Class B & A Sterile: Until 31 Dec 2029

Requirements include applying to a notified body and having a compliant QMS by set deadlines. Obelis is here to assist with compliance and QMS implementation.

Read the full article -> https://www.obelis.net/news/extended-ivdr-legacy-period-officially-published/

Obelis Group at Cosmoprof Las Vegas! 🎉📅 July 23 - 25, 2024 📍 Mandalay Bay Convention Center, Las VegasYesterday was our ...
24/07/2024

Obelis Group at Cosmoprof Las Vegas! 🎉

📅 July 23 - 25, 2024

📍 Mandalay Bay Convention Center, Las Vegas

Yesterday was our first day at Cosmoprof Las Vegas, and it was fantastic!

We connected with many cosmetic professionals and shared insights about our regulatory compliance and market entry services. The energy and innovation in the beauty industry are truly inspiring.

If you're attending, don't miss the chance to meet with us and discover how we can help your business thrive. Schedule a meeting today!

🔗 Schedule a meeting -> https://lnkd.in/eaY57FXz

🚨 Live Webinar: General Product Safety - Get Ready for December 2024 Deadline! 📅 Date: Thursday, July 18, 2024🕓 Time: 4:...
17/07/2024

🚨 Live Webinar: General Product Safety - Get Ready for December 2024 Deadline!

📅 Date: Thursday, July 18, 2024

🕓 Time: 4:00 PM - 5:00 PM (UTC+02:00) Brussels, Copenhagen, Madrid, Paris

🎙️ Speaker: Katerina Svambergova, Regulatory Expert

Agenda:

🔹 Transition from Directive (GPSD) to Regulation (GPSR): Key requirements to be compliant with GPSR.

🔹 EU Responsible Person vs. European Authorised Representative: Differences and obligations.

🔹 Online Sales: New requirements for distance selling and who needs to comply.

⏳ Join our upcoming webinar to gain a comprehensive understanding of these crucial topics!

🔗 Register now to secure your spot ->https://lnkd.in/eGKhBmKS

📢 IVDR Legacy RoadmapCheck out our comprehensive roadmap for navigating the IVDR legacy transition! 🛤️Also, don't miss t...
10/07/2024

📢 IVDR Legacy Roadmap

Check out our comprehensive roadmap for navigating the IVDR legacy transition! 🛤️

Also, don't miss these crucial updates:

🔸IVD Legacy Manufacturers: Important Deadlines & Steps - Ensure you're up to date with key deadlines and necessary actions. https://lnkd.in/ewPt5kSM

🔸Newly Published Q&A from the European Commission - Get the latest insights on the new Regulation amending EU MDR & IVDR. https://lnkd.in/deyX6U76

Stay informed and compliant!

💡

🚀 MHRA's AI Regulatory Strategy for Medical Devices This Spring, the MHRA unveiled its approach to AI in medical product...
04/07/2024

🚀 MHRA's AI Regulatory Strategy for Medical Devices

This Spring, the MHRA unveiled its approach to AI in medical products, building on the Government’s 2023 White Paper, ‘A pro-innovation approach to AI regulation.’

🔹 Key Principles: Safety, transparency, fairness, accountability, and contestability. The MHRA aims to position the UK as a global leader in science and technology by 2030.

🔹 Strategic Focus:

- Regulation: Ensuring AI in medical contexts complies with UK regulations.

- Efficiency: Using AI to speed up regulatory processes and access to medical products.

- Safety: Evidence-based oversight of AI to protect public and patient safety.

🔹 Framework Highlights:

- Pre-market Assessment: Rigorous evaluation of AI medical devices.

- Clinical Evidence: Proof of effectiveness and safety in real-world settings.

- Quality Management: Ensuring consistency and reliability of AI algorithms.

- Post-market Surveillance: Ongoing monitoring for safety and performance.

- Transparency and Accountability: Clear decision-making processes and mechanisms for handling errors.

Find all details here -> https://lnkd.in/eKpEEP9x

🚨 Live Webinar: General Product Safety - Get Ready for December 2024 Deadline! Are you dealing with products under the G...
02/07/2024

🚨 Live Webinar: General Product Safety - Get Ready for December 2024 Deadline!

Are you dealing with products under the GPSD or GPSR regulations? Then this webinar is for you!

📅 Date: Thursday, July 18, 2024

🕓 Time: 4:00 PM - 5:00 PM (UTC+02:00) Brussels, Copenhagen, Madrid, Paris

🎙️ Speaker: Katerina Svambergova, Regulatory Expert

Agenda:

🔹 Transition from Directive (GPSD) to Regulation (GPSR): Key requirements to be compliant with GPSR.

🔹 EU Responsible Person vs. European Authorised Representative: Differences and obligations.

🔹 Online Sales: New requirements for distance selling and who needs to comply.

⏳ Join our upcoming webinar to gain a comprehensive understanding of these crucial topics!

🔗 Register now to secure your spot ->https://lnkd.in/eGKhBmKS

🌟 Join Us at Cosmoprof North America! 🌟We are thrilled to announce our participation in Cosmoprof Las Vegas, happening f...
27/06/2024

🌟 Join Us at Cosmoprof North America! 🌟

We are thrilled to announce our participation in Cosmoprof Las Vegas, happening from 23-25 July in Las Vegas, USA!

➡ Why Meet Us?

Whether you're interested in our services, or simply want to explore potential partnerships, our representatives are ready to engage in as many discussions you need and provide insights tailored to your needs.

📅 Event Details:

Date: 23-25 July

Location: Las Vegas, USA

🔗 Schedule a meeting with one of our company representatives today: https://lnkd.in/eaY57FXz

Looking forward to seeing you at Cosmoprof Las Vegas!

🚀 Clinical Investigations of Medical Devices in the EU 🇪🇺To sell in the EU, manufacturers must demonstrate safety and pe...
24/06/2024

🚀 Clinical Investigations of Medical Devices in the EU 🇪🇺

To sell in the EU, manufacturers must demonstrate safety and performance through clinical data representative of the target population.

🔍 Key Points:
🔸Target Population: Data must match EU demographics.
🔸Non-EU Manufacturers: Conduct investigations in the EU even if not CE-marked.

📋 Clinical Investigation Plan (CIP):
🔸Outlines objectives, design, monitoring, and analysis.
🔸Details for competent authorities to assess risks vs. benefits.

📝 Requirements:
🔸Articles 62-80 MDR: Set investigation guidelines.
🔸Legal Rep: Non-EU sponsors need an EU-based representative.

🌐 Obelis Services:
🔸Review and submit documentation
🔸Manage authorizations and modifications
🔸Communicate investigation status and reports

Find the rest of the details in our latest article ->https://lnkd.in/eHf2Yhqw

🚨 Attention! 🚨There are only 6 working days left to complete the facility registration & product listing for your cosmet...
21/06/2024

🚨 Attention! 🚨

There are only 6 working days left to complete the facility registration & product listing for your cosmetic products. ⏳

Contact Obelis today, and we'll gladly support you in both procedures -> https://lnkd.in/epXQNw8Q

Don't let the deadline catch you!

🌍 UK to Accept Medical Devices from EU, US, Australia, and Canada 🌍Starting 2025, the UK will recognize medical devices ...
20/06/2024

🌍 UK to Accept Medical Devices from EU, US, Australia, and Canada 🌍

Starting 2025, the UK will recognize medical devices compliant with EU, US, Australia, and Canada regulations. This aims to boost medical device supply and enhance patient health.

🔍 Key Points:
🔸CE-marked devices recognized until 30 June 2030.
🔸New compliance routes available.
🔸UKCA marking still an option.

🏥 Requirements:
🔸Compliance with original country's laws.
🔸Upcoming UK post-market surveillance (PMS).
🔸English labels.
🔸Unique Device Identifier (UDI).
🔸UK Responsible Person.

🚫 Exclusions:
🔸Custom-made devices.
🔸Certain medical software.
🔸Get ready for these exciting changes to access the UK market!

Get all the details here -> https://lnkd.in/esdDJF_b

🚨 MoCRA Deadline Approaching: Are You Ready for July 1st? Join us for an essential webinar on Thursday, June 27, 2024, f...
19/06/2024

🚨 MoCRA Deadline Approaching: Are You Ready for July 1st?

Join us for an essential webinar on Thursday, June 27, 2024, from 4:00 PM - 5:00 PM to ensure you're fully prepared for the upcoming MoCRA compliance deadline.

Don't miss out on this opportunity to get all the information you need to stay compliant.

🔗 Register now: https://lnkd.in/eHdD6rv9

Stay ahead of the curve and make sure your business is ready for July 1st!

🚀 Selling Legacy Medical Devices in Switzerland After 26 May 2024 🇨🇭Swiss Medtech's new guidance helps manufacturers wit...
13/06/2024

🚀 Selling Legacy Medical Devices in Switzerland After 26 May 2024 🇨🇭

Swiss Medtech's new guidance helps manufacturers with CE-marked devices post-deadline.

🔍 Key Points:

- Market Restrictions: Non-MDR legacy devices can't be placed on the market in Switzerland/EU after 26 May 2024.
- Existing Devices: Can stay on the market if placed by 26 May 2024.

📋 For MDR Transitioned Devices:

- MDR application and compliant QMS by 26 May 2024 required.
- Requirements: Swiss authorized representative and MedDO compliance.
- Deadline: MDR agreement by 26 September 2024.
- Questions on Swiss, EU, or UK markets? Let’s connect!

Have a look into the full article ->https://obelis.ch/sell-legacy-medical-devices-on-the-swiss-market-after-26-may-2024/

🚨 Its TODAY! MoCRA Deadline July 1st: Is Your Cosmetic Brand Ready? 🗓️ Wednesday, June 12, 2024🕔 5:00 PM - 6:00 PM🎤 Spea...
12/06/2024

🚨 Its TODAY!

MoCRA Deadline July 1st: Is Your Cosmetic Brand Ready?

🗓️ Wednesday, June 12, 2024
🕔 5:00 PM - 6:00 PM
🎤 Speaker: Geoff Waby, Board Director - Obelis USA LLC

Agenda:

⏳ Is Your Cosmetic Brand Ready for the next MoCRA Deadline on July 1st?
📢 Remember: FDA begins enforcing facility registration and product listing.

Register today -> https://obelis.webex.com/weblink/register/r9714f7bb213b288ef0bdd9a0b71ccd8c

Is your Cosmetic Brand ready for MoCRA? Join our webinar and learn about the latest MoCRA deadlines!🗓️ Wednesday, June 1...
11/06/2024

Is your Cosmetic Brand ready for MoCRA?

Join our webinar and learn about the latest MoCRA deadlines!

🗓️ Wednesday, June 12, 2024
🕔 5:00 PM - 6:00 PM
🎤 Speaker: Geoff Waby, Board Director - Obelis USA LLC

Agenda:
⏳ Is Your Cosmetic Brand Ready for the next MoCRA Deadline on July 1st?

📢 Remember: FDA begins enforcing facility registration and product listing.

In the world of beauty, staying ahead is key! All brand owners and manufacturing facilities worldwide selling products in the USA market must be compliant by July 1, 2024.

If you're one of these companies, join this webinar to learn what you need to do to meet the FDA MoCRA requirements before the deadline.

🔗 https:https://obelis.webex.com/weblink/register/r9714f7bb213b288ef0bdd9a0b71ccd8c

In May 2024, the UK announced plans to accept medical devices compliant with EU, US, Australia, and Canada regulations s...
10/06/2024

In May 2024, the UK announced plans to accept medical devices compliant with EU, US, Australia, and Canada regulations starting in 2025. This aims to improve patient health and streamline market access.

🔍 Key Points:

- CE-marked devices from the EU recognized until June 30, 2030.
- New recognition for devices from Australia, Canada, the EU, and the US.
- Requirements: local law compliance, UK post-market surveillance, English labels, unique device identifiers (UDI), and a UK Responsible Person.

❗ Exclusions:

- Certain devices like custom-made devices and specific software.

🌐 UK Responsible Person:

- Non-UK manufacturers must appoint a UK Responsible Person for the UK market.

This initiative enhances the availability and quality of medical devices in the UK. Stay tuned for more updates!

have a look at the full article -> https://www.obelis.co.uk/medical-devices-compliant-eu-us-australia-canada/

05/06/2024

💊✨ These are vitamins!

In Europe, they’re considered food supplements. They can claim to be necessary for a healthy diet or to reduce your stress. Some might even promise to give you energy for 10 consecutive hours. 🌿

💪 But beware! These claims can make them non-compliant. 🚫

Remember, compliance comes first!

✅ Ensuring your products meet regulatory standards is key.

Have a look at the mandatory Food Supplement requirements here -> https://www.obelis.net/industries/food-supplements/

🚨 New Toy Safety Regulation and Digital Product Passport In March 2024, the European Parliament approved the new Toy Saf...
04/06/2024

🚨 New Toy Safety Regulation and Digital Product Passport

In March 2024, the European Parliament approved the new Toy Safety Regulation, replacing Directive 2009/48/EC. This update addresses shortcomings in protecting children from hazardous chemicals in toys.

Key Changes:

🔹Stricter product safety requirements

🔹Enhanced conformity assessments

🔹Introduction of the Digital Product Passport

Digital Product Passport: Toys sold in the EU will now need a Digital Product Passport, accessible via watermark or QR code. It replaces the EU declaration of conformity and includes:

🔸Unique product identifier

🔸Manufacturer’s and economic operator’s details

🔸Compliance with EU legislation and standards

🔸CE marking

🔸List of allergenic fragrances

🔸Any substance of concern

🔸For more details, check out the full article on MDlaw.

Find out all the details -> https://www.obelis.net/news/toy-safety-regulation-and-the-digital-product-passport/

📍 Yesterday, we had the pleasure of welcoming our partner AXG INDUSTRIES SDN BHD, in our headquarter in Brussels. As a p...
31/05/2024

📍 Yesterday, we had the pleasure of welcoming our partner AXG INDUSTRIES SDN BHD, in our headquarter in Brussels.

As a prominent glove manufacturer and supplier based in Klang, Selangor, Malaysia.AXG INDUSTRIES specializes in producing high-quality latex and rubber gloves, offering OEM and private label options for export.🧤

Our consultants explained all the necessary steps and procedures to ensure their compliance with different market regulations. This guidance is crucial for navigating the complex regulatory landscapes and ensuring successful market entry.

🤝 We would like to thank the AXG INDUSTRIES team for their incredible disposition and teamwork spirit. We hope our collaboration lasts many years and brings mutual success.

🚨 MoCRA Deadline July 1st: Is Your Cosmetic Brand Ready? 🗓️ Wednesday, June 12, 2024🕔 5:00 PM - 6:00 PM🎤 Speaker: Geoff ...
30/05/2024

🚨 MoCRA Deadline July 1st: Is Your Cosmetic Brand Ready?

🗓️ Wednesday, June 12, 2024
🕔 5:00 PM - 6:00 PM
🎤 Speaker: Geoff Waby, Board Director - Obelis USA LLC

Agenda:
⏳ Is Your Cosmetic Brand Ready for the next MoCRA Deadline on July 1st?

📢 Remember: FDA begins enforcing facility registration and product listing.

In the world of beauty, staying ahead is key! All brand owners and manufacturing facilities worldwide selling products in the USA market must be compliant by July 1, 2024.

If you're one of these companies, join this webinar to learn what you need to do to meet the FDA MoCRA requirements before the deadline.

🔗 https://lnkd.in/g-VQRfmS

IT'S TOMORROW!🚀Live webinar in collaboration with KIWA, a renowned Notified Body, focusing on the Medical Device Regulat...
27/05/2024

IT'S TOMORROW!

🚀Live webinar in collaboration with KIWA, a renowned Notified Body, focusing on the Medical Device Regulation (MDR) Certification process.

🗓️ Date: Tuesday, May 28, 2024
🕐 Time: 4:00 PM - 5:00 PM (CET)
💻 Platform: Teams

Are you going to miss it?

Register today -> 71d0ae13-9083-47eb-b71d-441faabb6192@d85f4d2b-56ee-448e-a2b8-da1bd42f9561" rel="ugc" target="_blank">https://events.teams.microsoft.com/event/71d0ae13-9083-47eb-b71d-441faabb6192@d85f4d2b-56ee-448e-a2b8-da1bd42f9561

Our experts in regulatory affairs recently provided onsite training to one of our most valuable clients in india, Meril ...
24/05/2024

Our experts in regulatory affairs recently provided onsite training to one of our most valuable clients in india, Meril .

📍 Our comprehensive sessions ensured that all their employees are well-prepared for any regulatory matters related to placing their medical devices in the EU, UK, or Switzerland under MDR/IVDR.

Founded in 2006, Meril is a leading Indian multi-national company focused on healthcare diversification. Our experience with the Meril team was exceptional, allowing us to build meaningful relationships and engage in valuable discussions with numerous team members. This exchange of knowledge and expertise was a fantastic opportunity to broaden the horizons and possibilities for both our companies. 🗣

We sincerely thank the entire Meril team and look forward to strengthening our partnership in the years to come. 🤝

❗One more day to go for China Beauty Expo!We have met many wonderful cosmetic beauty professionals interested in our reg...
23/05/2024

❗One more day to go for China Beauty Expo!

We have met many wonderful cosmetic beauty professionals interested in our regulatory knowledge for cosmetic regulations and upcoming deadlines.

Our company representatives are ready to answer all your questions and deal with your compliance needs.

Make sure you connect with us!

🔗 Schedule a meeting -> https://lnkd.in/e-Vv_Uib

Looking forward to connecting with you!

Live Webinar: EU, UK, US Cosmetics Regulations - A Talk on White Labels and Compliance🗓️ Date: Wednesday, May 29, 2024🕙 ...
23/05/2024

Live Webinar: EU, UK, US Cosmetics Regulations - A Talk on White Labels and Compliance

🗓️ Date: Wednesday, May 29, 2024
🕙 Time: 10:00 AM - 11:00 AM

🎤 Speakers:
🔸Sittidej Somprakit, Marketing Manager
🔸Francesca Santacatterina, Expert Consultant

Agenda:

📢 A straightforward guide to compliance in the EU, UK, and US for small cosmetic brands. Don't miss out!

🔹 Are you waiting to know how to list your products or register your facility with the FDA?
🔹 Did you know that the FDA has published details of the portal which you will be required to use?
🔹 Do you want to see the paper-based alternative procedure?

⏳ Join our upcoming webinar to gain a comprehensive understanding of these topics!

Register Now -> https://lnkd.in/ebiwEVUW

🌟 The RP Mandate: An Essential Document for Cosmetic Compliance 🌟The EU Cosmetics Regulation mandates that only products...
21/05/2024

🌟 The RP Mandate: An Essential Document for Cosmetic Compliance 🌟

The EU Cosmetics Regulation mandates that only products with a designated Responsible Person (RP) within the European Union can be placed on the market. Here’s what you need to know:

🔹EU-Based Companies: These companies act as their own RP.
🔹Non-EU Companies: For these companies, the RP is the importer.

Ensuring you have an RP is crucial for compliance and market access. Make sure your products meet all regulatory requirements and stay ahead in the competitive cosmetics market!

Find out all the details here -> https://www.obelis.net/news/the-rp-mandate-an-essential-document-for-cosmetic-compliance/

🚀 We are thrilled to invite you to an insightful webinar hosted by Obelis Group in collaboration with KIWA, a renowned N...
16/05/2024

🚀 We are thrilled to invite you to an insightful webinar hosted by Obelis Group in collaboration with KIWA, a renowned Notified Body, focusing on the Medical Device Regulation (MDR) Certification process.

🗓️ Date: Tuesday, May 28, 2024
🕐 Time: 4:00 PM - 5:00 PM (CET)
💻 Platform: Teams

Agenda:
🔹Insights from the Notified Body's perspective, emphasizing key areas manufacturers should focus on to facilitate a seamless MDR Certification process.
🔹Valuable tips for navigating the MDR conformity assessment and related topics.
🔹Discussion on the role of the European Authorized Representative (EAR) and our approach for both legacy and non-legacy manufacturers.

Register today -> 71d0ae13-9083-47eb-b71d-441faabb6192@d85f4d2b-56ee-448e-a2b8-da1bd42f9561" rel="ugc" target="_blank">https://events.teams.microsoft.com/event/71d0ae13-9083-47eb-b71d-441faabb6192@d85f4d2b-56ee-448e-a2b8-da1bd42f9561

It's Today! 📢Join us for our live webinar and make sure you are on the safe side!🗓️ Date: Wednesday, May 15, 2024🕐 Time:...
15/05/2024

It's Today! 📢

Join us for our live webinar and make sure you are on the safe side!

🗓️ Date: Wednesday, May 15, 2024
🕐 Time: 4:00 PM - 5:00 PM (CET)
💻 Platform: Webex

This webinar will focus on the following topics:

🔹Legacy period for medical devices certified under previous directives
🔹New extension period
🔹Derogation process
🔹Application in Switzerland

Register today and secure your spot -> https://obelis.webex.com/weblink/register/reae8b508f43fa28458319c6a8989d516

Obelis Group has landed at Vitafoods Europe 2024! 🚀📅 Join us from May 14th to 16th in beautiful Geneva, Switzerland. 🇨🇭W...
14/05/2024

Obelis Group has landed at Vitafoods Europe 2024! 🚀

📅 Join us from May 14th to 16th in beautiful Geneva, Switzerland. 🇨🇭

We are thrilled to extend a warm welcome to all food supplement professionals attending this year's Vitafoods Europe! 🎉

It's an incredible opportunity to come together, exchange insights, and stay up to date with the latest regulatory events shaping our industry. 🌿🔍

Our team at Obelis Group is eager to engage with you, share expertise, and collaborate on navigating the ever-evolving regulatory landscape. Let's connect!

Book a meeting with one of our company representatives today -> https://lnkd.in/e5tcPMuC

We're thrilled to announce that Obelis Group will be attending the upcoming China Beauty Expo from May 22nd to 24th in S...
10/05/2024

We're thrilled to announce that Obelis Group will be attending the upcoming China Beauty Expo from May 22nd to 24th in Shanghai, China! 🎉

This prestigious event brings together industry leaders, innovators, and beauty enthusiasts from around the globe to explore the latest trends, technologies, and products in the beauty sector.

We're looking forward to connecting with fellow professionals, sharing insights, and exploring opportunities to enhance regulatory compliance and product safety in the cosmetics industry.

Are you attending China Beauty Expo too? Let's meet up and discuss how we can collaborate to ensure compliance and success in this dynamic market!

🔗 Schedule a meeting -> https://forms.zohopublic.com/obelis/form/ChinaBeautyExpoShanghai2024/formperma/N-hR9kK-LlSvVfPMGUZwcfxI2B1WxudYBlUxyVFJwmI

Hearing aids, Reusable surgical instruments, Condoms, Heart valves are just a few examples of Legacy devices that will b...
08/05/2024

Hearing aids, Reusable surgical instruments, Condoms, Heart valves are just a few examples of Legacy devices that will be affected by this imminent deadline. 📢

Join us for our upcoming live webinar and make sure you are on the safe side!

🗓️ Date: Wednesday, May 15, 2024
🕐 Time: 4:00 PM - 5:00 PM (CET)
💻 Platform: Webex

This webinar will focus on the following topics:

🔹Legacy period for medical devices certified under previous directives
🔹New extension period
🔹Derogation process
🔹Application in Switzerland

Register today and secure your spot -> https://obelis.webex.com/weblink/register/reae8b508f43fa28458319c6a8989d516

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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.


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