Foreseeable Misuse of the New ISO 14971:2019 and EU MDR
Thursday, June 17 | 11:15 am - 12:00 pm
Product Development, Quality/Regulatory
Recent changes to ISO 14971 (ISO 14971:2019) and the release of the EU Medical Device Regulation (MDR/2017/745) have reshaped the requirements for risk management for medical device manufacturers. In this presentation, we will discuss the updates to ISO 14971 and the specific risk management requirements for MDR. We will then discuss implementation strategies and how the changes affect manufacturers. Finally, we will review the updated Technical Report ISO/TR 24971, which now contains many of the informative annexes from ISO 14971 and additional new annexes.
Awareness of the changes to ISO 14971:2019
Knowledge of MDR risk management requirements
Overview of an implementation strategy for adopting both, ISO 14971:2019 and MDR risk management requirements
Information on how to use ISO/TR 24971:2020