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EUDAMED Update – MDR Second Amendment is official!

Device Registration module is now LIVE

Where are you at with EU MDR compliance?

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.

What is

EUDAMED is the European Database for Medical and In Vitro Diagnostic Devices developed by the European Commission.

What is

MDR (Medical Device Regulation) is Europe’s new regulatory framework which replaced the former MDD (Medical Device Directive) from 26 May 2021.

Device Registration

Your answers to Europe’s Medical Device Regulation and its online system for pre-market registration of Medical and In Vitro Diagnostic devices.

EUDAMED Leadership
Council on LinkedIn

Join our LinkedIn group of EUDAMED Thought Leaders to gain insights, share ideas and experiences in implementing EUDAMED best practices.

EU Commission
published documents

Read the latest communications and guidance from the EU Commission relating to MDR application and EUDAMED data compliance.

EU Commission
technical documentation

Download your Technical Specifications, Data Dictionary, Business Rules and Enumerated Code Lists to get started with preparing your master data for EUDAMED submission.

MedTech Europe
published documents

Get the latest MedTech Europe documentation and discussion papers relating to MDR, EUDAMED other Medical Technology industry news.