With the first landmark penalty officially issued under the Digital Services Act, Very Large Online Platforms selling in Europe must immediately audit their compliance strategies to mitigate massive financial and reputational risks.
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Market Access Is Only the Beginning: The Growing Importance of Regulatory Control for Cosmetics in Türkiye
For many foreign manufacturers, particularly in the cosmetics sector, entering the Turkish market starts with a local distributor.
At the outset, this is often the most practical and efficient approach. The distributor supports commercial activities while also handling regulatory compliance, product registrations and interactions with local authorities, making it easier to establish a presence in the market.
Is EUDAMED Fully Functional? Latest Live Date Updates & Final Preparation Steps
The question of when EUDAMED is fully functional has followed the medical device sector for years, through repeated delays and shifting timelines. The status is now clear and the answer has direct consequences for market access in the EU.
Strengthening MDR Compliance Through EUDAMED Verification
With Obelis Group’s support, TTK Healthcare Limited successfully completed EUDAMED verification for its Class III heart valve devices, strengthening MDR compliance and supporting its continued growth in the European market.
Entered the Wrong Information in EUDAMED, Now What?
What happens if incorrect information has been entered during device registration and EUDAMED does not allow the information to be corrected directly?
Fortunately, this situation is easier to fix than many manufacturers expect.
Bringing Premium Skincare to the EU and UK Markets with Confidence
ODACITÉ partnered with Obelis Group to achieve EU and UK compliance for its Nourishing Lip Serum SPF 40. With support for safety assessment, product notifications, and regulatory guidance, the brand successfully brought its product to market with confidence.
Why EUDAMED Draft Status Offers Zero Legal Protection After May 28
An EUDAMED draft is invisible to national competent authorities for compliance purposes. It cannot be referenced in an inspection, it does not satisfy registration obligations, and it offers no regulatory standing in the event of a query.
Successfully Managing Large-Scale EUDAMED Compliance
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. successfully completed large-scale EUDAMED verification for more than 1,100 medical devices with the support of Obelis Group, ensuring efficient EU compliance and smooth registration of Class Ir and Class Is devices.
IVDR Readiness in 2026: Why Delayed Operational Setup Creates Major Risks
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in vitro diagnostic medical devices, authorised representatives, and distributors operating in the EU, IVDR operational readiness in 2026 is no longer a future milestone – it is a present obligation.
Ensuring Seamless EU Market Continuity Through EUDAMED Expertise
Biobeat Technologies Ltd. successfully completed its EUDAMED verification and mandate update with the support of Obelis Group, ensuring uninterrupted access to the EU market through clear regulatory guidance and expert support.