Free White Paper
Impact Assessment of Revision of the Regulatory Framework for Medical Device Directive in EU
Inside this White Paper
The transition from the Medical Device Directive (MDD) to the In Vitro Diagnostic Regulation (IVDR) represents a significant shift in the European regulatory landscape for medical devices. This white paper from Regulatory Compliance Associates® provides an in-depth analysis of the changes introduced by the IVDR, including enhanced oversight of Notified Bodies, stricter post-market surveillance requirements, and the introduction of unique device identification (UDI) systems. It also addresses the challenges manufacturers may face during this transition and offers strategic guidance to ensure compliance. Whether you’re a manufacturer, importer, or distributor, this resource is essential for understanding the new regulatory requirements and maintaining market access in the EU.