Last September, our President, Brandy Chittester, and CEO, Sandra Maddock presented a webinar about the pending implementation of these requirements in order to review the purpose, impact, challenges, and strategies that should be considered when preparing for the implementation.
In light of the current COVID-19 pandemic, implementation of these requirements was delayed for one year. In April 2020, the European Parliament agreed to this delay by a vote of 693-1. This proposal was approved by member states and listed in the Official Journal on April 23, 2020 (almost one month before they were to go into effect). This delay was proposed in order to allow the medical device industry to prioritize their coronavirus response efforts.
With an extra year to prepare, what are the downstream implications for the delay and what can be done during this period to take advantage of the extra time available?
- Medical device companies should be able to focus efforts on the reason for the delay: the coronavirus. This delay will allow companies to confirm that adequate resources and efforts are available to support the COVID-19 response.
- Companies that were not on track for meeting the original deadline will have additional time to ensure that internal steps are in place to support these requirements. Whether it be shoring up internal resources or outsourcing assistance, a 12-month delay will provide these companies an opportunity to prepare for the implementation; however, this may not be easy as the COVID-19 response could provide a constraint on resources to support MDR implementation efforts.
- The delay could offer companies additional time to familiarize themselves with the requirements, implications of these requirements, and time to construct the infrastructure necessary to meet the requirements. In a press release supporting the delay, MedTech Europe noted “that the time must be used to continue rapidly building the new regulatory system and bringing it into full functionality, for example by having a greater number of notified bodies designated and operational under the MDR, by developing the needed MDR guidance documents.”
Of note, the pending deadline of the In Vitro Diagnostic Medical Device Requirements (IVDR) (slated for 26 May 2022) have not been delayed.
With the one-year delay, how has your implementation plan changed and how are you using the extra time available?
To learn more about navigating the MDR and IVDR regulations, check out our interactive resource.