 |
Medical Device made Easy PodcastHelping you placing compliant medical device on the market. Author: easymedicaldevice
My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter. Language: en Genres: Business, Entrepreneurship Contact email: Get it Feed URL: Get it iTunes ID: Get it |
Listen Now...
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
Episode 381
Wednesday, 18 March, 2026
The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.While many companies believe this transition is simply about uploading documents into a European database, the reality is far more complex.EUDAMED is not just a database — it is becoming the central regulatory infrastructure of the European medical device ecosystem, connecting manufacturers, notified bodies, regulators, and economic operators.Why EUDAMED MattersEUDAMED aims to increase:• Transparency• Traceability• Post-market surveillance• Regulatory oversightTo achieve this, companies must ensure that their internal data is structured, accurate, and aligned with regulatory expectations.The Biggest MistakeThe most common misconception is treating EUDAMED as an IT project.In reality, it is a data governance challenge.Before uploading any device, companies must clearly define:• Device families• Basic UDI-DI and UDI-DI• Certificate linkage• Legal manufacturer responsibilitiesMany organizations struggle with these fundamentals.The 7-Step Readiness ChecklistTo prepare effectively, QA/RA teams should focus on:Actor registration (SRN)Cleaning the device portfolioValidating the UDI structureChecking certificate dataDefining legacy device strategyAssigning data ownershipPerforming a dry runRisks of Delayed PreparationCompanies that delay preparation may face:• Incomplete or inconsistent data• Registration delays• Regulatory bottlenecks• Internal confusionEUDAMED could quickly become a regulatory traffic jam for unprepared organizations.A Practical TimelineTo avoid these risks:• Immediately: Audit all regulatory data• Next 1–2 months: Validate UDI structure and device hierarchy• Before the deadline: Perform a full readiness simulationFinal TakeawayEUDAMED is not just a compliance requirement — it is a transformation of how regulatory information is managed in Europe.Companies that prepare early will transition smoothly.Those that wait may face significant delays and operational challenges.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
