The final implementation of the EU MDR this year was a key impetus behind the February 2019 ISO 11607-1/2 update. What has evolved since the release of the update, however, is further scrutiny. Specifically, regulators considered the broad direction of ISO 11607-2: 4.2. The new, brief clause simply states that medical device development activities should “consider risk management to medical devices.” The lack of detail and room for interpretation has been called into question. Ultimately, agreeing some definition was needed, the amending team has embarked on a refinement process.