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.
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.
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.
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.
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.
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.
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.
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.
With clear guidance from Obelis Group, Kogenebiotech Co., Ltd. achieved a smooth, confident, and fully compliant EU Class A IVD notification through transparent communication and precise guidance.
Luxe Assist Global Inc. partnered with Obelis Group to streamline compliance, refine labelling, and confidently achieve a smooth, delay-free UK market entry for their microneedle derma roller.