The risk analysis is one of the basic documents within technical documentation. Accordingly, risk management is one of the most important parts of quality management. Thus, already the preamble of MDR/IVDR requires a risk management system (32). Furthermore, it is part of the general obligations of manufacturers (Article 10). Besides, the general requirements of MDD/IVDD have been renamed into general safety and performance requirements (Annex I) which again stresses the importance of the medical devices safety.

Correspondingly, ISO 13485:2016 introduced the risk based approach as well. All parts of the quality management system have to follow this approach. Even outsourced processes have to be risk based.

Risk management is defined in detail in ISO 14971 which is part of FDA's list of Recognized Consensus Standard and also listed on EU's Harmonised Standards. Worldwide risk analysis is required for product registration of medical devices. Usually, it is done according to ISO 14971 and accepted by the respective officials.

In December 2019 the 3rd edition of ISO:14971 has been published as ISO 14971:2019. Especially the requirements for production and post-production acitivities have been specified in four sub-chapters which corresponds to the stronger accentuation of the Post-market Surveillance in MDR/IVDR. Besides, the new version considers the benefit of the devices slightly more than its predecessor. Furthermore, a new Technical Support was published as guidance to the application of ISO 14971: ISO TR 24971:2020. Some appendices of EN ISO 14791:2012 have been moved to  ISO TR 24971:2020, thus putting more emphasis on ISO 24971.

I looking forward to support you with the creation/extension of your risk analysis as well as with the adaptation of your risk management system.