Obelis GROUP

🚀 From idea to EU market: here’s what it really takes

Getting your medical device CE marked isn’t just a step, it’s a process that defines your market access in Europe. Under MDR/IVDR, manufacturers must navigate classification, conformity assessment, documentation, EUDAMED registration, and post-market obligations, all while ensuring safety and compliance.

To make it clearer, we’ve broken it down into 10 key steps you need to follow to successfully place your device on the EU market.
👉 Swipe through to see the full roadmap

📩 Need guidance? Contact us to support your EU market access journey.

Hello São Paulo 👋

Our team is at this week, reconnecting with clients, meeting with our trusted partners, and discovering the latest innovations shaping the future of the medical device industry.

Connecting with innovative medical device companies and discussing the latest industry developments is always a highlight for our team. We’re proud to share our expertise in global regulatory compliance and support businesses in navigating international market access with confidence.

From evolving regulatory frameworks to worldwide compliance strategies, we’re here to support companies looking to expand globally and stay compliant across different markets.

👉 If you’re attending Hospitalar and would like to speak with our experts, feel free to send us a message, we’d be happy to connect!

EU Fragrance Allergens Rules Are Changing! The EU has updated its cosmetics legislation under Regulation (EU) 2023/1545, expanding fragrance allergen labelling from 24 to 80+ substances, a major step toward greater transparency and consumer protection.

Newly listed allergens include substances such as linalool, limonene, geraniol, citronellol, and eugenol, many of which are commonly found in fragrances and essential oils.

✔️ What should manufacturers and brand owners do now?
• Review formulations and identify allergen presence
• Assess concentrations against labelling thresholds
• Update product labels and packaging
• Align claims and marketing materials
• Plan ahead for reformulation if needed

👉Talk with your RP now, early preparation ensures a smooth transition and continued access to the EU market

🤝 Strengthening international collaboration and market access opportunities!

Obelis Group's Chief Compliance Officer, Sandra Ferretti, together with Obelis Türkiye CEO, Selim Erol, proudly attended the official visit aimed at reinforcing the relationship between Belgium and Türkiye.

During this important event, Obelis Group had the opportunity to connect with many promising partners, exchange insights with industry stakeholders, and present how we support companies with international market access and regulatory compliance strategies.

With the strong local presence of Obelis Türkiye, we continue bridging global expertise with regional knowledge to help businesses navigate complex regulatory landscapes and expand confidently into new markets. 🌍✨

A great occasion to foster collaboration, innovation, and future opportunities between both countries.

The Obelis Group team is live at Beauty Istanbul together with our Obelis Türkiye colleagues!

Whether you need support with cosmetic regulatory compliance in Türkiye or global market access worldwide, our experts are ready to help you navigate the regulatory landscape with confidence. 🌍

📍 Visit us at Hall 10A – Booth 430
💬 Bring your regulatory challenges and meet our team in person!

See you there 👋

Sun, innovation, and global connections ☀️🌍

Our team is live from Casablanca, Morocco, attending GITEX Future Health Africa to discover the next wave of medical device innovators and connect with industry leaders. From emerging technologies to regulatory challenges, we’re here to talk compliance across key markets and help bring life-saving solutions closer to patients worldwide.

Let’s connect if you’re here 👋

🚨 The EUDAMED deadline is almost here : 28 May

Medical device manufacturers placing products on the EU market must ensure their EUDAMED obligations are fully completed. This includes Actor Registration (SRN), UDI data submission, and verifying all relevant certificates and economic operator links.

Failing to comply is not just a delay, it’s a risk:
• Restricted or lost EU market access
• Disruptions in supply chain and distribution
• Increased regulatory scrutiny
• Potential product withdrawal or penalties

👉 Don’t wait until the last minute. Make sure your data is complete, accurate, and submitted on time.

Big news for medical device manufacturers ‼️

The Medicines and Healthcare products Regulatory Agency is considering indefinite recognition of CE-marked devices in Great Britain, a move that could significantly reshape market access in the UK.

💡 What does this mean?
✔️ Continued acceptance of CE-marked devices
✔️ Reduced regulatory duplication between the EU and UK
✔️ Greater market continuity and improved patient access

For businesses, this could simplify compliance strategies and ease entry into the UK market, but it’s still under consultation, and stakeholder input will be key in shaping the final outcome.

Now is the time to assess your regulatory roadmap and ensure you’re prepared for what’s next.

MDR & IVDR classification doesn’t have to be confusing ⚠️

One wrong classification = delays, extra costs… or worse.

In this quick guide, discover:
✔️ How to classify your device correctly
✔️ What impacts your regulatory pathway
✔️ Mistakes you must avoid

Get it right from the start, your market access depends on it.

👉 Swipe to simplify it.