At the end of April, our team attended the MDMA’s annual meeting and came back with the following 3 key takeaways.

1) The CDRH received an unprecedented workload of EUAs and pre-EUAs due to the COVID-19 pandemic

The COVID-19 pandemic has created an unprecedented workload for the CDRH, with over 4,000 EUAs and pre-EUAs submissions since January 2020. The CDRH has had to be agile, proactively engaged, and maintain a flexible regulatory framework to meet the challenges of the pandemic. The lessons learned from this experience can help inform future approaches to regulatory processes during public health emergencies.

2) CMS is facing coverage challenges with emerging technologies

CMS is currently facing coverage challenges with emerging technologies, and anyone can ask to open an NCD to establish conditions of coverage. The agency considers multiple factors when making coverage decisions, such as benefit categories, coding, evidence of benefit, and risk of harm. The strength of evidence and risk of harm, as well as patient, provider, and facility characteristics, are also important considerations.

3) Updates and implications on device regulations in Europe

The updates and implications in Europe include several remaining problems that impact device regulations, including the need for more capacity for recerts, unclear EMA roles, and uncertain approaches to AI medical devices. The Commission is working on addressing these issues by having all applicant Notified Bodies online by the end of 2023, presenting medium and long-term solutions for orphan devices, establishing a pilot project for specific expert advice, and preparing a root and branch review of MDR and IVDR ahead of 2027. In addition, there are new regulations in the UK and a new Innovative Devices Access Pathway Regulation. Manufacturers should focus on MDR transitions and compliance, and not delay or postpone MDR submissions.