Discover Health Canada’s update requiring a Canadian-based representative for foreign cosmetic brands and how Obelis can help with compliance.
News
EU PMS requirements for medical devices under scrutiny of Dutch authority
Dutch audits reveal non-compliance with EU post-market surveillance (PMS) requirements for medical devices. Learn how to strengthen PMS systems for compliance and safety.
Upcoming February 2025 cosmetics deadlines: amendments to Annex II and Annex III
Key February 2025 alert for the cosmetics industry: new EU rules restrict ingredients like Genistein, Kojic Acid, and Alpha-Arbutin under Annex III and ban specific nanomaterials under Annex II.
Cosmetics labelling: a guide to EU compliance for diverse product types
Discover the information that must be visible on the labels of cosmetic products under article 19 of the EU Cosmetics Regulation.
Anticipating and notifying supply interruptions or discontinuations under article 10a MDR and IVDR
Learn about the new Article 10a under EU MDR and IVDR, requiring manufacturers to notify authorities and stakeholders of potential medical device or IVD supply interruptions. Understand the scope, notification process, and exemptions, as well as how to comply with these regulations to ensure patient safety and continuity of care.
Responsible Person and Authorised Representative under GPSR: new EU requirements for general products
Discover the new EU General Product Safety Regulation (GPSR) requirements effective 13 December 2024. Learn about the role of Responsible Person and Authorised Representative (EAR) to ensure product compliance in the EU market.
Distance sales devices: a look at EU requirements
Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.
Mutual recognition of regulations between the EU and Switzerland
Discover how the EU and Switzerland maintain strong trade relations through mutual regulation agreements, enabling smoother market access for many products.
New Regulation for general products applies from December 2024
From 13 December 2024, the new EU General Product Safety Regulation (GPSR) applies, requiring stricter safety measures and a Responsible Person for all products.
26 September 2024: last call for manufacturers of legacy devices
Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.