Under Regulation (EU) 2015/2283, a novel food is generally a food that was not consumed to a significant degree within the European Union before 15 May 1997 and falls within one of the categories defined by the legislation.
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EUDAMED November 2026 Deadline: What to Do Now to Be Ready
The 28 November 2026 EUDAMED deadline is approaching. Manufacturers must register eligible legacy and MDR/IVDR medical devices still being placed on the EU market. Discover which devices are affected, what data to prepare, and how to avoid last-minute registration delays.
EU Fragrance Allergen Regulation: What It Means for Cosmetic Formulations
Two cosmetic products can have varying fragrance compositions and still display the same allergen name on their ingredient lists.
Health Claims: When does a supplement promise too much?
Under Regulation (EC) No 1924/2006, health claims on food supplements must comply with specific requirements. These claims describe a relationship between a food, or one of its ingredients, and health.
Supporting Regulatory Progress for Class IIb X-Ray Systems
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.
Selling Food Supplements Online in the EU: Key Compliance Requirements in 2026
Selling food supplements online in the EU follows the same food law as in-store sales. This guide covers notification, labelling, mandatory product page information, permitted ingredients and claims in 2026.
A Smooth Path to EU and UK Cosmetic Markets
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.
Extending Medical Device Compliance to the Swiss Market
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.
The business of moving forward: 38 years of Obelis
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.
Taking Our First Steps into the European Market
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.