ISO 14971 is a global risk management standard that has just been updated in keeping with technological and regulatory changes in the medtech industry. In the EU, the standard is relevant to all medical devices and IVDs and reinforces the current medical device directives and the future medical devices and IVD regulations (EU) 2017/745 and 2017/746 (MDR and IVDR).
The Role of ISO14971:2019 for the MDR and IVDR and harmonisation status
Risk management has to be included at every level into a manufacturer’s quality system and needs to be explained in the technical documentation. Due to the risk-based approach in many aspects and the life-cycle principle inherent in the MDR and IVDR, the new ISO 14971 revision has one of the first deadlines of all EU standards for harmonisation in the context of the MDR and IVDR. However, it seems unlikely that this will happen in time in view of the short period until 26 May 2020.
Still, as an overall principle, manufacturers should comply to the state of the art. ISO14971:2019 is the most recent standard on risk management and Notified Bodies and competent authorities will expect at least a documented plan for compliance with the new revision.
What are the biggest changes in the new revision?
The three biggest changes in the new version are:
- The risk management plan calls for inclusion of criteria for acceptability of individual residual risk and overall residual risk, including the method used to establish overall residual risk.
- A benefit risk analysis has to be carried out on each residual risk, and the overall residual risks have to be assessed against the benefits of the intended use.
- The risk management process, including what measures have to be taken and information about production and post-production activities, are better explained.
ISO 14971:2019 is a product-focused risk management standard that entails involvement of numerous processes. The content is debated and decided on with input from worldwide experts, industry and regulators. Using this standard (and ISO TR 24971 as guidance) will facilitate manufacturers to satisfy regulators expectations around the world, including the EU.
Source: Medtech Insight (an Informa product)