Discover how Obelis supported Harsoria Healthcare in expanding its Class IIa medical device portfolio into Switzerland. From reviewing the applicable Swiss regulatory requirements to supporting registration in swissdamed, Obelis helped ensure a smooth and well-organized market entry process.
Gideon had started Obelis alone from an office in a city house in Brussels. Across the street stood a maternity hospital. Spotting an opportunity, he even opened a small snack business from the office for a while.
Discover how Medorah Meditek prepared three Class I medical devices for the European market with Obelis’ support on MDR compliance, technical documentation review, and EUDAMED verification, helping the company move forward with greater confidence.
A single fragrance composition can contain dozens, sometimes even hundreds of individual ingredients. Until you have to work out which of them belongs on a cosmetic label, that is probably little more than an interesting fact.
Health Canada’s Cosmetic Notification Form (CNF) requirements have undergone significant updates, affecting how cosmetics are notified, labelled and placed on the Canadian market. From Canadian address requirements to expanded fragrance allergen disclosures, businesses selling cosmetics in Canada need to review their existing filings and ensure they meet the latest 2026 requirements.
28 May 2026 was a major milestone for EUDAMED. However, it was not the last important date in the 2026 EUDAMED transition. Following the mandatory use of four EUDAMED modules in May, manufacturers and other economic operators have already entered a new phase of the EUDAMED rollout.
Since 28 May 2026, the EUDAMED UDI/Devices module has been mandatory to use. For applicable legacy devices that continue to be placed on the EU market, the transition period provides until 28 November 2026 to complete their registration in the UDI/Devices module.
Discover how Obelis Group supported REVE LTD. throughout its UK cosmetics compliance journey, from PIF review and CPSR preparation to SCPN notification, helping the company bring its lipstick to market smoothly, efficiently, and with confidence.
Discover how Obelis Group supported Sanava AB throughout the complete EU cosmetics compliance process, including laboratory testing, CPSR preparation, PIF review and CPNP notification, helping the company confidently bring its night face cream to the European market.
The European Commission’s €550 million fine against AliExpress under the Digital Services Act marks a major shift in marketplace enforcement. While the decision targets the platform, manufacturers and sellers should expect stricter compliance checks, stronger product verification requirements, and greater scrutiny when selling products in the EU.