The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
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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.
How to Approach the Final Days Before the EUDAMED 2026 Deadline in May?
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
This article outlines the key actions still required, highlights where organisations most often fall short, and provides guidance on navigating the final stretch before the EUDAMED deadline without making costly mistakes.
Ensuring EU Compliance for High-Quality Cycling Components
Ritchey Design Inc. partnered with Obelis Group to ensure full EU compliance for its product portfolio under the GPSR. Through expert technical reviews and ongoing Authorized Representation, Ritchey reinforces its commitment to safety and excellence in the European cycling market.
Preparing for the July 2026 EU deadline on fragrance allergens disclosure: best practices
On 31 July 2026, a new European Union regulatory requirement affecting the majority of cosmetic products will become applicable. By this date, beauty brands placing products on the EU market must ensure that their labels include – where applicable – the disclosure of 56 additional fragrance allergens in the ingredient list.
Confident UK Market Access Through Expert Regulatory Support
Koru Pharma Co., Ltd. successfully entered the UK market with the expert regulatory support of Obelis Group. Through clear guidance on MHRA registration and UK-specific requirements, the process was smooth, efficient, and fully compliant.
Seamless UK Compliance for Fragrance Portfolio Expansion
SUPERZ Perfume Kft. partnered with Obelis Group to ensure full UK compliance for 29 fragrance products. With expert guidance from Obelis consultant Sofia Rocha, all products were successfully reviewed and notified, enabling smooth market entry while strengthening internal processes for future growth.
Confident EU Market Entry Through Expert IVDR Support
Athenese-Dx partnered with Obelis Group to navigate the EU IVDR process, achieving full compliance and successful EUDAMED registration for their biochemistry analyser, enabling confident entry into the EU market.
Obelis Group Partners with IBA to Keep Beauty Brands Ahead of U.S. Cosmetic Regulations
Through our partnership with the Independent Beauty Association and our sponsorship of the Fiscal Note U.S. Policy Map, we equip beauty brands with real-time regulatory insights and expert support, helping them stay compliant with MoCRA and confidently navigate the U.S. market.
2026 Cosmetics Labelling Deadlines Impacting Global Compliance
The year 2026 brings numerous regulatory deadlines affecting cosmetic product labelling across several territories, including the European Union, United Kingdom, Switzerland, Canada, and the United States.