The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.
Authorised Representative
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.