Australia, often referred to as the skin cancer capital of the world, is facing a…
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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.
New substances banned in cosmetics in the EU: Omnibus Acts VII and VIII
In 2025, the EU introduced Omnibus Acts VII and VIII, banning and restricting several substances in cosmetics due to CMR classifications. These changes require immediate compliance. Learn how Obelis can help ensure your products meet the latest regulations.
Navigating UK Medical Device Registration
KORAVIE LIMITED, a UK-based start-up, partnered with Obelis Group to navigate the complexities of UK medical device registration. With expert guidance and hands-on support, they transformed regulatory uncertainty into a successful market launch—laying the groundwork for EU expansion.
New Restriction on Homosalate in Cosmetics Comes into Effect on 1 July 2025
From 1 July 2025, the EU will enforce new limits on Homosalate in cosmetics, allowing a max of 7.34% in face products. Reformulation may be required to ensure compliance.
EU MDR Regulation Explained: Requirements & Compliance
A number of regulatory requirements must be taken into account when introducing medical devices into…
GDPR and clinical investigations: who is the data controller?
Understand who qualifies as the data controller in clinical investigations under the EU MDR and GDPR. Learn the roles of sponsors and investigators, the implications of joint controllership, and the legal responsibilities tied to personal data processing in clinical trials.
Distribution of Medical Devices in Global Markets
The global medical device industry operates within an increasingly intricate regulatory web. As healthcare innovation…