The MEDEV guidance currently under revision in the EU will cover all medical device directives and is inclusive of two decision trees which assist manufacturers in determining if software is regulated under the Medical Devices Directive (MDD) or In Vitro Diagnostics Directive (IVDD). The International Medical Device Regulatory Forum (IMDRF) also released a guidance document outlining SaMD definitions to institute a collective structure for regulators to integrate united controls into SaMD regulatory tactics. The US FDA is expected to release a guidance addressing clarifications on wellness and accessory issues this fall. While these guidance’s have been helpful to industry manufacturers, many areas remain unclear such as the concept of a software “accessory” and where medical functionality begins or ends. By examining grey areas in both US and EU recommendations, executives will have an enhanced understanding of compliant practice and how to efficiently develop medical device and diagnostic software. A comparison of US and EU frameworks will be used throughout the discussion.
- Defining medical device and IVD software
- Examining how software will be regulated under the revised MDD and the expected FDA guidances
- Key timetables and projections
- Proactive steps for manufacturers
Bethany J. Hills
Member of the Firm
Epstein Becker Green