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Description: Medical device risk management is an iterative process that starts at the beginning of product development and evolves throughout the lifecycle of the device. Following the requirements set out in EN ISO 14971:2019 “medical devices - application of risk management to medical devices”, medical device risk management aims to: • Identify, quantify, and evaluate all risks, • Reduce these through effective control measures, • Ensure patient safety through determining whether the benefits of the device outweigh the residual risks, • Ensure new or emerging risks are identified and evaluated through the medical device risk management process. Whilst ISO 14971 provides a framework to ensure adequate medical device risk assessment is conducted, it is in the implementation of the standard, and specifically when applied to Europe and the Medical Device Regulation (MDR) (EU) 2017/745, that common mistakes are being made.
What are some of the most frequent points raised by Notified Bodies relating to medical device risk management? • Not all risks have been identified/assessed. • Risks are not reduced as far as possible. • Use of risk acceptance means that not all possible control measures have been considered. • Individual risks do not have a benefit/risk assessment. So why are these gaps occurring if a manufacturer follows ISO 14971:2019? To understand this, we need to understand the difference between the international standard, ISO 14971:2019, and the European MDR.
This presentation describes the relationship between the standard and the European regulation and highlights areas where deficiencies are occurring in manufacturer’s risk management documentation, with the aim of resulting in more compliant risk management documentation for MDR submissions.
Learning Objectives:
To understand the journey from EN ISO 14971:2012 content deviations into the MDR text (GSPR 2-8) and how compliance to EN ISO 14971:2019 links back to the MDR.
To understand the divergence between the international standard ISO 14971:2019 and the MDR.
To know the areas of common non-conformities, and to ensure the risk management documentation is written in compliance to the MDR.
