A Timely Reminder About Cosmetic Claims Each summer, sunscreen returns to the spotlight as consumers…
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Selling Detergents in Europe: Compliance Goes Beyond the Formula
A Good Formulation Is Only the First Step When most manufacturers think about detergent compliance, they think about…
EUDAMED Actor and Device Registration Requirements: Who Must Register and When?
With EUDAMED now mandatory across the EU, manufacturers, importers, and authorised representatives alike are wondering:…
Newly Harmonised Standard Introduces the “EU-REP” Symbol
A newly harmonised version of EN ISO 15223-1 introduces the new EU-REP symbol, replacing EC-REP under the EU MDR and IVDR. Learn about the key changes, the transition period until 17 June 2031, and what manufacturers need to do to remain compliant.
The EU’s first major DSA enforcement action is a warning sign that compliance can no longer be an afterthought
With the first landmark penalty officially issued under the Digital Services Act, Very Large Online…
Market Access Is Only the Beginning: The Growing Importance of Regulatory Control for Cosmetics in Türkiye
Growing Beyond Initial Market Access for Cosmetics Manufacturers For many foreign manufacturers, particularly in the cosmetics…
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…
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…
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.