The EU MDR Deadlines Are Here.
Medical device manufacturers worldwide are facing a looming crisis. The clock is ticking on the EU MDR Implementation Training as crucial transition deadlines fast approach, threatening market access and potentially halting sales for non-compliant devices. Failure to act now could result in costly delays, product recalls, and significant financial penalties.
The Ticking Clock: Deadlines You Cannot Ignore
The time for theoretical guidance is over. The European Union has set concrete, non-negotiable deadlines for compliance. Ignoring these dates puts your entire product line and business at severe risk:
Device Class – | Final Transition Date (May 26, 2026 Regulation extended dates) |
Class III custom-made implantable devices – | May 26, 2026 |
Class III or Class IIb Implants (excluding WET devices) – | December 31, 2027 |
Other Class IIb, IIa, Is, Im, and Ir (including WET devices) – | December 31, 2028 |
Furthermore, the full functionality and mandatory use of the EUDAMED database for device registration is also a rapidly approaching requirement. Don’t be caught unprepared.
Your Last Chance: Supporting the Transition from MDD to MDR
MDR CONSULTANTS INC. provides the only actionable path forward. Our specialized MDD to MDR Transition Course cuts through the complexity, focusing strictly on practical implementation to mitigate your risk immediately. This isn’t just training; it’s survival guidance delivered by those who hold the keys to approval.
Participants will learn directly how to secure market access by:
Led by a team of former FDA Reviewers and Notified Body Lead Auditors, this program offers unparalleled real-world insights into compliance expectations.
Act Now to Avoid the Crisis
Don’t let regulatory complexity be the downfall of your market access strategy. Secure your place in our program and ensure your business is ready for the new era of medical device regulation. The risk of non-compliance has never been higher, and the time to secure your compliance is running out.
Visit www.mdrconsultants.com today to enroll and protect your future.
About The Author:
Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.
This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com
Optimized by Seraphinite Accelerator