New version of EN ISO 14971 “Medical devices. Application of risk management to medical devices” published by CEN. On December 2019, the new version of EN ISO 14971:2019 “Medical devices. Application of risk management to medical devices”has been published by ISO and CEN, replacing the 2007 version. This standard deals with processes for managing risks associated with medical devices and it has been developed specifically for manufacturers of medical devices. All CEN members shall adopt it as national standard before next 30-06-2020.
The requirements of the standard are applicable to all phases of the life cycle of a medical device, applying to risks related to biocompatibility, data and system security, electricity, moving parts, radiation usability.
In addition, and as a complementary document, the following technical report is under development: CEN/ISO TR 20416 “Medical devices. Post-market surveillance for manufacturers”. This document will help to establish a common understanding of the post-market surveillance process and it will be addressed for use by medical devices manufacturers. The process described is consistent with EN ISO 14971, and consists on a proactive and systematic way that manufacturers can use to collect and analyse appropriate data, in order to provide information for the feed-back processes and use it to meet applicable regulatory requirements to gain experience from the post-production activities.
Both documents are of most importance for the MIRACLE Project to serve as guidance in the development of the MIR-ART probe for arthroscopic use.