Extensions for the European Union MDR and IVDR
Key EU medical device regulation updatesInitial EU MDR and IVDR transition periods extended
In 2023, the European Union granted an extension for the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by manufacturers and other stakeholders in achieving compliance within the initially set timelines. Here’s an overview of the extension granted for both regulations:
Extension of MDR Implementation
The European Union granted an additional two-year extension for the implementation of the MDR, extending the deadline to May 26, 2023. This extension was primarily in response to challenges faced by manufacturers in meeting the requirements of the MDR, including issues related to the availability of notified body services, the complexity of the regulatory changes, and the impact of the COVID-19 pandemic on resources and timelines.
The extension provided manufacturers with more time to complete conformity assessment procedures, update technical documentation, and ensure compliance with the new regulatory requirements. It aimed to alleviate some of the pressure on manufacturers and notified bodies while maintaining patient safety and the integrity of the EU market for medical devices.
Extension of IVDR Implementation
Similarly, the European Union granted an extension for the implementation of the IVDR, extending the deadline by one year to May 26, 2023. The extension was prompted by similar challenges faced by manufacturers and notified bodies in meeting the requirements of the IVDR within the originally set timelines.
The extension allowed manufacturers of in vitro diagnostic medical devices additional time to comply with the stricter requirements of the IVDR, including performance evaluation, clinical evidence requirements, and conformity assessment procedures. It aimed to ensure a smoother transition to the new regulatory framework and mitigate potential disruptions to the supply of in vitro diagnostic medical devices within the EU market.
Summary
In summary, the extensions granted for the implementation of the MDR and IVDR provided manufacturers and other stakeholders with additional time to achieve compliance with the new regulatory requirements. These extensions aimed to address challenges faced by the industry while maintaining patient safety and the integrity of the EU market for medical devices and in vitro diagnostic medical devices.
Read more about the implementation of the EU MDR and IVDR.
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