EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
News
Leading Through Complexity: Doram Elkayam, on Multi-Market Compliance and the Road to 2026
Obelis COO Doram Elkayam shares how he navigates complex EU, UK, US, Swiss and Canadian regulations to streamline multi-market access for medical devices, IVDs, cosmetics and more. In this interview, he reflects on 2025, key trends for 2026, and why smart regulatory strategy is now a business essential.
Strategic Compliance for a New Generation of Wellness Products
Kind Patches Ltd. partnered with Obelis Group to build a clear, future-proof compliance strategy for launching nutrient-delivery wellness patches in the EU and UK. Through in-depth regulatory research, step-by-step consultancy, and EU/UK GPSR compliance reviews, Obelis helped transform complex requirements into a structured pathway for confident market entry and long-term growth.
EU Market Entry Success Story: RED Directive Compliance in 7 Days with Obelis VIP
Discover how Boundless Devices Inc., a U.S.-based technology company, successfully entered the EU market in just 7 days. With Obelis Group’s VIP service and EAR support, the company achieved fast and seamless compliance under the Radio Equipment Directive (RED), transforming regulatory complexity into a confident and efficient EU market launch.
The Vision Behind Obelis: Insights from Obelis CEO, Gideon Elkayam
Gideon Elkayam, Obelis Group’s CEO shares how the company transformed from an EU Authorized Representative into a global compliance partner, turning regulatory complexity into confidence, faster market access, and sustainable growth for manufacturers worldwide.
Upcoming Cosmetics deadline in the EU – New restrictions on Retinol, Retinol Equivalents, and Triclocarban and Triclosan
The European Commission has announced new cosmetics compliance deadlines affecting Retinol, Triclosan, and several nanomaterials. From late 2025, products containing these ingredients must meet stricter safety limits or be withdrawn from the EU market. Learn what these changes mean for your formulations and labelling.
The Sunscreen Scandal: What’s Happening in Australia
Australia, often referred to as the skin cancer capital of the world, is facing a…
Revision of the Medical Devices Regulations in the EU
Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
EU IVDR Regulation: What It Is, Compliance Guide & Requirements
The EU In Vitro Diagnostic Regulation (IVDR) formally known as Regulation (EU) 2017/746replaces the former…
September 2025 deadline for IVDs in the EU: signed agreement for class D legacy devices
Manufacturers of Class D IVDs must sign an agreement with a notified body by 26 September 2025 to benefit from IVDR transitional periods. Learn about the deadlines, requirements, and how Obelis supports the process.