In response to ongoing concerns about medical device shortages, the European Union (EU) Council has endorsed new measures aimed at addressing these challenges. The agreed-upon revisions not only focus on preventing shortages but also include updates to registration procedures for the electronic European database on medical devices. Furthermore, an extension to the transition period for in vitro diagnostic medical devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR) has been approved.

The move comes amid growing awareness of the vulnerabilities in the medical device supply chain, highlighted by disruptions caused by various factors such as the COVID-19 pandemic and regulatory changes. Ensuring a stable and uninterrupted supply of medical devices is crucial for maintaining healthcare services and safeguarding patient care.

By endorsing these measures, the EU aims to enhance regulatory oversight and streamline processes to mitigate potential shortages. Updating registrations in the electronic European database for medical devices will improve transparency and traceability throughout the supply chain, enabling better monitoring and management of device distribution.

The extension to the transition period for IVDs under the IVDR provides manufacturers with additional time to comply with the new regulatory requirements, thereby reducing the risk of market disruptions due to non-compliance.

Overall, the EU Council’s endorsement of these measures underscores the importance of proactive regulatory action to address challenges in the medical device industry. By taking decisive steps to prevent shortages and enhance regulatory oversight, the EU seeks to strengthen the resilience of the healthcare system and ensure continued access to essential medical