Obelis Group

GB/UK Post Market Surveillance: What You Need to Know
2025-07-10 16:00 - 17:00 (Europe/Brussels)
Navigating the evolving regulatory landscape in the UK can be complex, especially when it comes to Post Market Surveillance (PMS).

Join us for this essential webinar as we break down the latest updates and practical requirements of the UK PMS (Amendment) (Great Britain) Regulations 2024. Whether you’re a medical device manufacturer, a UK Responsible Person, or part of a compliance or quality team, this session is your guide to ensuring ongoing product safety and regulatory alignment in the UK market.

Here’s some of what you can expect to learn:

✅PMS Regulation & Scope

✅Manufacturer Responsibilities

✅Risk Management & CAPA

✅Communication & Roles

🎯 When: July 10 | 16:00-17:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Alison Hinchliffe (KIWA) and Homer Trieu (Obelis Group)

Register here!

COSMOPROF 2025 - Las Vegas
2025-07-15 09:00 - 2025-07-17 18:00
Join us at Cosmoprof Las Vegas, the leading B2B beauty exhibition in the USA! We can help your company decode and comply with global regulations with confidence.What will you get in return?✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updatesLet’s talk! Set up a meeting in advance, and we’ll see you at your booth.Meet you there!

ADLM 2025 - Chicago
2025-07-27 09:00 - 2025-07-31 18:00
Scientific Meetings and Clinical Lab Expo? Looking forward to it! Join us and the global laboratory medicine community at ADML Chicago. Question about compliance? No need to worry, we are here to help you!Why Meet Us at ADML?✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updatesSet up a meeting in advance and let’s discuss it together at your booth.Looking forward to meet you at ADML Chicago!

EUDAMED & Swissdamed Explained: Key Modules and Timelines for Medical Devices
2025-09-09 16:00 - 17:00
Join us for an insightful webinar on EUDAMED and Swissdamed, where we’ll explore the key modules, important timelines, and compliance requirements for medical devices.

Webinar highlights include:

✅What is public?

✅Code Usage

✅Timelines

✅Client Experiences to date

🎯 When: September 9 | 16:00-17:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Richard Houlihan (EirMed) and Georgios Mariolos (Obelis Group)

Register here!

Navigating Canadian Ingredient Approval and the EU/UK Split
2025-09-30 15:00 - 16:00
Cosmetic regulations are evolving quickly, are you keeping up?

Join our interactive session where we will explore the Canadian, EU and UK frameworks using real-life examples to show you exactly how these rules can affect your business and impact your compliance journey. After this session, you will walk away with practical tips to navigate ingredient approvals and adapt your compliance strategy across markets.

Webinar highlights :✅ Canada’s Cosmetic Ingredient Hotlist: Purpose, update process, and what it means✅ Canada & EU Regulatory Frameworks: Points for divergence and areas of alignment✅ EU & UK Regulatory Frameworks: Key divergences following Brexit and their implications for compliance

🎯 When: September 30 | 15:00-16:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Chiara Lai (Obelis Group)

Register here!

EU vs Turkish Cosmetics Regulations: Key Differences and Compliance Pathways
2025-10-16 16:00 - 17:00
Join our webinar on EU vs. Turkish Cosmetics Regulations to understand the key differences in cosmetics notification systems, Responsible Person (RP) obligations, and labeling requirements. Whether you plan to register cosmetics in Türkiye or maintain EU compliance, this session will give you expert guidance on regulatory submissions, packaging compliance, and market access strategies; helping you stay compliant and avoid costly delays.

Webinar in Focus:✅Turkish vs. EU notification systems

✅RP obligations

✅Labeling requirements

✅ and much more…

🎯 When: October 16 | 14:00-17:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Katie Gallagher (Obelis Group) & A. Selim Erol (Macro Professional)

Register here!

MEDICA 2025 - Düsseldorf
2025-11-17 09:00 - 2025-11-20 18:00
Heard about MEDICA? It is one of the largest medical B2B trade fairs in the world and we will be there to support you!

Our goal is to assist your company in smoothly complying with global regulations.

Why Meet Us at MEDICA?

✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updates

Schedule a meeting in advance and let’s chat at the exhibition!

See you at MEDICA!

WEBINAR: ISO 13485:2016 & EU MDR/IVDR – From Scope to Certification
2025-12-11 16:00 - 17:00
ISO 13485:2016 is the backbone of a compliant medical device business and a key enabler for CE marking and international registrations. In this webinar, we’ll go beyond the basics and show, in practical terms, who ISO 13485 applies to, how it links with EU MDR/IVDR and ISO 9001, and how it supports market access.Through clear explanations and practical checklists, we will cover:– The scope of ISO 13485 and affected roles (manufacturers, ARs, importers, distributors)– Its relationship with EU MDR/IVDR, CE marking, and registrations in specific markets– The main clauses of the standard and what they expect from you– The essential documents and records you must have in place– The steps to achieve and maintain certification, and where our service fits into each stage👉 Reserve your spot now and take a concrete step towards a stronger, ISO 13485-compliant QMS.

Switzerland: Effective Date of Furocoumarin Restriction
2026-01-01 00:00 - 23:59
Switzerland – Effective Date of Furocoumarin Restriction

✅1 January 2026: In finished cosmetic products, excluding perfumes, eaux de toilette and eau de cologne, the sum of the concentrations of the furocoumarins Byakangelicol, Epoxy-bergamottin, Isopimpinellin, 5-Methoxypsoralen, 8-Methoxypsoralen, Oxypeucedanin, Oxypeucedanin hydrate and Psoralen must be present in quantities below 1 mg/kg, and natural essential oils must be dosed accordingly, where, under normal or reasonably foreseeable conditions of use, the cosmetic product: is not rinsed off; and may be directly exposed to sunlight.

Contact Obelis for expert guidance to ensure full compliance with the upcoming furocoumarin restrictions.

France: Ban Effective Date – January 2026
2026-01-01 00:00 - 23:59
France – PFAS prohibition effective date

✅01 January 2026: New prohibition for making available on the market products containing intentionally added PFAS

The 01 January 2026 PFAS ban is approaching, and timely compliance is key to keeping your products on the market without interruption. Obelis is here to provide expert guidance and practical support, ensuring you meet the new requirements efficiently and confidently.

Benzophenone‑3 & Methyl Salicylate Restrictions – January and March 2026
2026-01-21 00:00 - 2026-03-31 23:59
United Kingdom – Benzophenone‑3 & Methyl Salicylate Restrictions Deadlines

✅21 January 2026: Cosmetic products containing Benzophenone-3 and not complying with the restrictions outlined in Annex VI can no longer be placed on Great Britain’s market. For full details on the restrictions, please refer to this link.

✅31 March 2026: Cosmetic products containing Methyl Salicylate (CAS 119-36-8)and not complying with the restrictions outlined in Annex III can no longer be made available on Great Britain’s market. For full details on the restrictions, please refer to this link.

Check your product portfolio now to ensure compliance with the upcoming UK cosmetic ingredient restrictions and avoid market disruptions. Appoint Obelis now to manage your compliance.

EUDAMED, Swissdamed & IVDR Legacy: What You Need to Know
2026-01-29 15:00 - 16:00
Join us for an in-depth live webinar where we explore the latest developments in EUDAMED, the European database for medical devices. This session will provide a clear overview of the key EUDAMED modules, implementation timelines, and how they impact manufacturers and stakeholders. We will also cover Swissdamed, highlighting Switzerland’s alignment with European regulations, and discuss the legacy of IVDR, ensuring a smooth transition from the previous regulatory framework.

Whether you are a manufacturer, distributor, or regulatory professional, this webinar will equip you with practical insights to navigate compliance and stay ahead in the evolving regulatory landscape.

🎯 When: January 29 | 15:00-16:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Sandra Ferretti (Obelis Group – CCO) & Georgios Mariolos (Obelis Group – Legal Regional Consultant)

Register here!

WHX DUBAI - Former Arab Health
2026-02-09 09:00 - 2026-02-12 18:00
Heading to WHX Dubai 2026? It’s one of the most dynamic stages for international business growth and Obelis Group is excited to be part of it!

At Obelis, we help companies navigate complex medical devices and IVDs regulatory landscapes so they can enter markets with confidence and speed.

What You Can Expect When You Meet Us at WHX Dubai

✅ Strategic advice on expensing into global markets✅ Clear guidance on compliance requirements for your product category✅ Practical support to streamline approvals and reduce time-to-market

Let’s plan ahead. Book a slot with our experts and make the most of your visit.

Looking forward to connecting with you at WHX Dubai!

How 2026 Bans & Cosmetic Rules Will Impact Your Business?
2026-02-12 15:00 - 16:00
2026 will be a turning point for the cosmetics industry. With new bans, PFAS restrictions, allergens labelling rules, and tightened compliance deadlines across major markets, brands that don’t adapt quickly may face delays, reformulations, blocked products, or market loss.

Join our LIVE session where we’ll break down the most important 2026 regulatory shifts and show you exactly how to stay compliant, competitive and ready for growth. You’ll leave with concrete insights to protect your formulas, update your labelling and confidently navigate each region’s new expectations.

🎯 When: February 12 | 15:00-16:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Sofia Rocha (Obelis Group | Expert Consultant – Regulatory Affairs) & Giorgia Peotta (Obelis Group | RA Regional Consultant – Regulatory Intelligence & Innovation)

Register here!

10th ERPA Annual Summit
2026-02-24 09:00 - 2026-02-25 18:00
A New Milestone in Cosmetics Compliance & Safety

In 2026, the European Cosmetics Responsible Person Association (ERPA) Annual Conference – formerly known as the CRCC – enters a new chapter. With a new name, an expanded agenda, and a sharpened purpose, the event reflects the evolving needs of the cosmetics regulatory community.

Now reintroduced as the ERPA Annual Summit, this transformation responds to the growing demand for clarity, meaningful dialogue, and collaboration across the regulatory and scientific landscape of cosmetics compliance.

Obelis Group is proud to support this milestone edition as a Contributing Partner of the 10th ERPA Annual Summit.

📅24-25 February 2026

📍Leiden University, Netherlands

Discover more at: 10th ERPA Annual Summit 2026 | Home | Cosmetics Compliance & Safety

Get 15% off! Send us a message at mg@obelis.net

Powering Compliance: EU Battery Regulation for Portable Batteries
2026-03-12 15:00 - 16:00
Join us for an insightful webinar on EU battery regulation, with a focus on portable batteries. We will cover an overview of the EU Battery Regulation, highlight the main novelties, and explore key provisions specific to portable batteries. Gain practical guidance, understand compliance requirements, and learn how to navigate the evolving regulatory landscape effectively.🎯 When: March 12 | 15:00-16:00 CET

📌 Where: Online | Zoho Webinars

🎬 Guests: Simona Varrella (Obelis Group | Senior RII International Specialist – Regulatory Intelligence & Innovation) and Pablo Antiñanco (Director at RoHS or not)

Cosmoprof Bologna
2026-03-26 09:00 - 2026-03-28 18:00
Heading to Cosmoprof Bologna?One of the leading global events for the beauty and cosmetics industry, Cosmoprof Bologna is a key platform for international growth and Obelis Group is pleased to be part of it.

At Obelis, we support companies in navigating complex cosmetics regulatory landscapes, enabling confident and efficient access to global markets.

What you can expect when you meet us at Cosmoprof Bologna:

✅ Strategic advice on expanding into international markets✅ Clear guidance on regulatory and compliance requirements for your product category✅ Practical support to streamline approvals and reduce time to market

Let’s plan ahead. Book a slot with our experts and make the most of your visit.

Looking forward to connecting with you at Cosmoprof Bologna!

Navigating U.S. FDA Medical Device Regulations: Pathways & Lifecycle Compliance
2026-03-26 16:00 - 17:00
Entering the U.S. medical device market requires a clear understanding of FDA regulatory requirements throughout the entire product lifecycle. This webinar will guide you through the key elements manufacturers must consider when placing a device on the U.S. market and maintaining compliance over time.Our experts will cover essential topics including:✅Device classification✅Regulatory pathways (510(k), De Novo, and PMA)✅Labelling requirements✅Post-market surveillance obligations✅UDI implementation✅Implications of the FDA’s new Quality Management System Regulation (QMSR)Join us to gain practical insights into navigating the FDA regulatory framework and ensuring your medical devices remain compliant from market entry through post-market monitoring.

Canada Fragrance Allergen Disclosure – April 2026
2026-04-12 00:00 - 23:59
Canada – Fragrance Allergen Disclosure Deadline

✅12 April 2026: New and existing cosmetics have to disclose the 24 fragrance allergens listed below within the list of ingredients, when present at concentration greater than 0.01% in rinse-off products and 0.001% in leave-on products.

To ensure compliance with the above regulatory changes, we recommend reviewing and, where necessary, revising your product formulations. Obelis is here to support you at every step of the process.

Interclean Amsterdam
2026-04-14 09:00 - 2026-04-17 18:00
Making plans to attend Interclean Amsterdam?

This April, the world’s leading cleaning and hygiene event returns to the RAI Amsterdam with an expanded show floor and more international exhibitors. Interclean Amsterdam is the premier stage for the professional cleaning industry and Obelis Group is proud to be part of the movement.

At Obelis, we help manufacturers of detergents, disinfectants and professional cleaning equipment navigate the rigorous EU and global regulatory landscapes. Whether you are launching a new biocidal product or scaling smart cleaning technology, we ensure your path to market is compliant, confident, and efficient.

What you can expect when you meet us at Interclean:

✅ Expert Regulatory Guidance: Deep dives into compliance for detergents, disinfectants and Personal Protective Equipment (PPE).✅ Strategic Market Access: Advice on navigating the EU and UK markets, including Responsible Person and Authorized Representative services.✅ Innovation Support: Practical insights on streamlining approvals for the latest tech showcased in the Robot and Healthcare Experience Centers.

With the industry shifting toward automation and sustainability, having a strong regulatory strategy is more important than ever. Book a slot with our experts today to ensure your innovations are ready for the global stage.

Looking forward to connecting with you in Amsterdam this April!

The Critical Role of the Responsible Technical Person
2026-04-16 15:00 - 16:00
2026 is a critical year for cosmetic compliance – and the Responsible Technical Person is at the center of it.Join our 60-minute LIVE webinar to discover how to safeguard your products, avoid regulatory risks, and implement GMP with ISO 22716. ✅ GMP Essentials: key principles for cosmetic products✅ RTP Responsibilities: legal and operational must-knows✅ Practical Tips: ensure compliance efficiently✅ Expert Insights: from Sandra Ferretti, CCO at Obelis Group, and Selim Erol, CEO of Obelis TürkiyeReserve your spot now and stay ahead in cosmetic compliance!

ON-DEMAND WEBINAR: Food Supplements in the EU and UK – a focus on online sales (AMAZON)
2026-04-21 16:00 - 17:00
Get a clear and practical overview of the essential rules governing food supplements in the EU and UK. This on-demand webinar walks you through the core legislation and compliance requirements every Food Business Operator (FBO) must know.Webinar highlights :✅ Regulation (EC) 178/2002 – General Food Law✅ Brexit and its impact on labeling & notifications✅ Compliance challenges when selling on Amazon✅ How Obelis can support you as your FBOIdeal for manufacturers, distributors, Amazon sellers, and regulatory professionals looking for a quick, reliable guide to staying compliant in the EU and UK.

Omnibus Act VIII – May 2026
2026-05-01 00:00 - 23:59
European Union – Omnibus Act VIII amends the Cosmetic Regulations

✅1 May 2026: Products containing 3-(4′-methylbenzylidene)-camphor [INCI: 4-Methylbenzylidene Camphor] (CAS No 36861-47-9/38102-62-4) can no longer be made available on the market.

✅1 May 2026: With no distinction between placing products on the market and making them available, Omnibus Act VIII will apply. This means that, from the application date, non-compliant cosmetics can no longer be sold in the EU market and must be recalled beforehand.

Meeting regulatory deadlines is essential to avoid market disruptions and product recalls, and Obelis is here to support you every step of the way in ensuring timely compliance with Omnibus Act VIII requirements.

New amendment to EU Cosmetics Regulation: Retinol and other substances banned or restricted in cosmetics – COSlaw.eu – Guiding through EU Cosmetics Regulations: Winning with IVDR: Compliance Strategy, Class C Pathways & NB Engagement

GITEX Future Health Africa
2026-05-05 09:00 - 2026-05-06 18:00
Heading to GITEX Future Health Africa?As Africa’s leading platform for health innovation and policy, GITEX Future Health Africa is where healthcare’s evolution meets the continent’s digital future. Obelis Group is more than excited to be a part of this transformative event in Morocco this May.

In an era where AI and deep tech are reimagining health systems, Obelis stands ready to support your journey. We help MedTech and Digital Health innovators navigate complex regulatory landscapes.

What you can expect when you meet us in Morocco:

✅ Strategic Roadmaps: Expert advice on scaling your health innovations across African and international borders.✅ Tech-Forward Compliance: Clear guidance on regulatory requirements for AI-driven devices, software as a medical device (SaMD), and emerging health tech.✅ Accelerated Market Entry: Practical support to streamline approvals, ensuring your life-saving technology reaches providers and patients faster.

Don’t leave your regulatory strategy to chance. Book a dedicated slot with our experts ahead of time and maximise your impact at GITEX Future Health Africa.

Looking forward to connecting with you in Morocco on 5-6 May!

Winning with IVDR: Compliance Strategy, Class C Pathways & NB Engagement
2026-05-06 11:30 - 12:30
The IVDR transition is reshaping how IVD manufacturers approach compliance, evidence, and certification. This session will guide you through the most critical elements of the journey, from transition timelines and legacy provisions, to EUDAMED and UDI requirements, and what they mean in practice.

We will also dive into Class C classification and conformity assessment pathways, highlight the most common clinical evidence gaps identified by Notified Bodies, and share practical insights on how to work more effectively with Notified Bodies, including smarter communication and selection strategies to support successful approvals.Join us to gain clarity, reduce compliance risks, and strengthen your IVDR strategy. Register now to secure your spot.

Beauty Istanbul 2026
2026-05-07 10:00 - 2026-05-09 18:00
Keen on Beauty Care? Let’s meet at Beauty Istanbul, one of the largest cosmetics exhibitions worldwide! Our Mission? Helping cosmetics brands seamlessly adapt to global compliance standards.Why Meet Us at Beauty Istanbul?✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updatesLet’s connect to discuss how we can support your regulatory needs! Schedule a meeting with us in advance, and we’ll see you at our booth, yours, or wherever is convenient for you.

Obelis Booth: Hall 10/10A 430We look forward to meeting you at Beauty Istanbul!

IVDR Class C Transitional Deadline – May 2026
2026-05-26 00:00 - 23:59
As the transition to the In Vitro Diagnostic Regulation (IVDR) continues, we would like to remind you of the critical 2026 deadlines for legacy IVDs that are classified to Class C under IVDR.

For these devices, the following milestones apply:

✅A written agreement between the manufacturer and the Notified Body must be signed by 26 September 2026.

✅The manufacturer or their Authorised Representative must apply to a Notified Body for IVDR conformity assessment by 26 May 2026.

Obelis guides manufacturers through the IVDR transition, including selecting and engaging with a Notified Body.

EUDAMED Registration Becomes Mandatory – May 2026
2026-05-28 00:00 - 23:59
Regulatory Alert | EUDAMED becomes mandatory

Commission Decision (EU) 2025/2371 confirms the full functionality of the first four EUDAMED modules. As a result, economic operators must comply with mandatory registration requirements.

Mandatory modules from 28 May 2026:

✅Market Surveillance

✅Actors: registration of manufacturers, authorised representatives, importers

✅UDI / Devices: device registration (excluding custom-made devices)

✅Notified Bodies & Certificates

A six-month transition period (until November 27, 2026) applies only to devices placed on the market before May 28, 2026. Devices placed on the market after this date must be registered before market access.

Obelis supports manufacturers at every step of EUDAMED compliance!
