March 2023 Medical Device and IVD News Update

This month we'll look at the latest on the 21 CFR 820 and ISO 13485 harmonization, Germany’s focus on digital health applications (DiGA), and key training dates for your calendar.

Almost a year ago, a proposed rule was published in the US federal register, which lays out FDA’s plan to harmonize the current medical device Quality System Regulation with ISO 13485:2016. The deadline for comments expired in May last year and according to the US Office of Information and Regulatory Affairs website, we can expect the new rule to be implemented by the end of 2023.

For now, check out our handy tool exploring the relationship between ISO 13485:2016 and the US FDA quality system regulation.

When the Digital Healthcare Act entered into force in December 2019, a dedicated pathway enabling reimbursement of digital health offerings was introduced to the German healthcare system. This enabled patients in the Statutory Health Insurance system to be reimbursed for digital health applications (digitale Gesundheitsanwendungen, or DiGAs) on prescription by doctors or psychotherapists.

Read our article which was published in the Journal of Medical Device Regulation on data protection, data security and positive care effects for digital health applications.

Join industry experts in the heart of Hamburg, Germany for an engaging discussion on MDR transition periods, how to get competitive and sustainable medical devices to market, and more!

September 14-15 2023 | Hamburg

Booking open soon!