Following a formal request from MedTech Europe, the European Union (EU) Medical Device Regulation (MDR) deadline has officially been changed. The 12-month extension on the deadline means medical device companies have until May 26, 2021, and can continue to focus on supporting global COVID-19 needs.
The regulation will require companies to recertify some existing medical devices and certify new products entering the market. In March, a proposal moved forward that would see the deadline delayed, allowing not only medical device companies, but also governments, to turn their full attention to the COVID-19 pandemic.
The proposal was passed by the European Parliament on April 17, and EU institutions have now officially adopted the changes.
Similar measures have not yet been enacted for the In Vitro Diagnostic Regulation (IVDR), which is scheduled to take effect on May 26, 2022.
Deadline Change Impact
The new EU MDR deadline means companies will have an additional year to acquire substance data and prepare technical files. While the deadline has been extended, these files still take a significant amount of time and effort to prepare.
In-scope companies must be aware that over the next 12 months, the core substance list will be updated, expanding the list of in-scope substances; while the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation’s Candidate List of Substances of Very High Concern (SVHCs) will update at least twice.
Despite the deadline extension, companies must be aware of their requirements and should already have begun preparations for the EU MDR. To learn more, download our guide, Building an Effective EU MDR Program.
The European Databank on Medical Devices (EUDAMED) is scheduled to go live in March 2021, allowing companies to submit medical device data in advance of the new May 2021 deadline.
Questions still remain surrounding the EU MDR deadline change, such as if notified body audits will be able to be conducted virtually, given COVID-19 circumstances.
Assent is the industry-leading supply chain data management solution, enabling efficient and effective collection, validation and management of data related to product compliance regulations such as the EU MDR. To learn more about how Assent’s EU MDR Solution can help, contact us today.