Risk management for medical devices is an essential part of the technical documentation and covers all product-specific risks that may occur throughout the life cycle of the medical device.
Although currently EN ISO 14971:2012 as well as the revision from 2019 are not yet harmonised standards with the European Medical Device Regulation (2017/745 (MDR) or 2017/746 (IVDR)) but had been used to implement Directive 93/42/EEC and thus is a requirement to date. The requirement to summarise the results of risk management in a risk management file consisting of at least a risk management plan, a risk analysis and a risk report still exists.
The European Legislation – the MDR - is legally binding since 26 May 2021 and has significantly expanded risk management compared to the formerly Directive 93/42/EEC - the MDD - and requires careful adaptation and documentation.
Particularly medical device manufacturers about to develop a new product often have difficulties in creating a risk management file and successfully implementing the new requirements of the MDR or IVDR. To determine and describe hazardous situations and the resulting risks possibly leading to damage to patient, user or the environment it is used in are often the greatest challenges.
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