Software as a Medical Device: Anticipated Guidance Documents Highlight Ongoing Challenges in EU and US

1 Hour and 20 Minute Video | Bethany J. Hills, Epstein Becker Green

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

Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Legal Counsel
  • Quality Assurance


This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

Bethany J. Hills
Member of the Firm
Epstein Becker Green

Bethany J. Hills is a Member of the Firm in the Health Care and Life Sciences practice, in the New York office of Epstein Becker Green. She counsels life science, medical device, and health care provider businesses on a broad range of reimbursement, regulatory, and compliance matters.

Chambers USA has ranked Ms. Hills among the “Up-and-Coming Individuals” in the Healthcare category in 2012 and 2013. She was named a “Rising Star” by New York Super Lawyers – Metro Edition in 2013. Additionally, Ms. Hills is a recipient of the ABA and BNA Award for superior academic performance in the field of health law and a Lester Milbrath fellowship from the Environment and Society Institute. She is a frequent lecturer and author on health industry compliance issues and works with academic centers to educate future business leaders on regulatory issues for innovative products and businesses.


Recent Events

Purchase Now

Purchase Now