EU MDR Deadline Alert: Act Now to Ensure Compliance, Extensions Are NOT Automatic!
As part of our commitment to regulatory compliance and ensuring the highest standards in healthcare product safety, we wish to bring your attention to the imminent compliance deadline for the European Union Medical Device Regulation (EU MDR) 2017/745 and address common misconceptions surrounding Regulation (EU) 2023/607 which amends the transition period.
The clock is ticking and May 26, 2024 will be here before we know it. Are you ready?
The extension is NOT automatic, there are still things manufacturers must do to qualify for the extension. Before we get into that let’s talk about the consequences of non-compliance:
The stakes are extremely high, failure to comply with the EU MDR by the deadline will result in the inability to market and distribute your medical devices within the European Union.
So, what do you need to do to qualify for the extension?
Implement a quality management system compliant with EU MDR by May 26, 2024.
Submit an application to a notified body for CE Mark under MDR by May 26, 2024.
Sign a contract with a notified body for CE Mark under MDR by September 26, 2024.
Ensure your devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC.
Maintain the design and intended purpose of your device(s) without significant changes.
Ensure devices do not present an unacceptable risk to the health or safety of patients. users or other persons, or to other aspects of the protection of public health.
Need help preparing and ensuring you qualify for the extension? Contact Nicohl at Nicohl.Asher@Benten-Creative.com or 773.343.2039
