Today, medical device manufacturers are confronted with an ever-changing landscape for regulatory compliance around the globe. Faced with increasing uncertainty in terms of meeting EUDAMED compliance, device manufacturers are now counting down to a fully functioning EUDAMED system to be in production by Q4 of 2024. With the EU Commission’s current timelines, the completed EUDAMED system is expected to be independently audited and ready for production use by mid-2024 – when the ‘production ready’ EUDAMED system is to be published in the Official Journal of the European Union.

On 15 March 2023, the European Parliament passed Regulation 2023/607 (aka Second Amendment to MDR) to extend the transition timeline for medical devices already in circulation in the European markets. This amendment also abolishes the requirement to “sell-off” for any devices placed into the market prior to MDR or IVDR came into effect.

Innovit have you covered, with all the information and tools you require today, to meet evolving Medical Device Regulations (MDR) and EUDAMED compliance. So bookmark this page as your launch pad to find everything you ‘need to know’ about EUDAMED and your quest for compliance.