New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
The new European standard aligns closely with regulations in FDA 21 CFR 820, meaning for medical device makers already doing business in this country, many of the changes should be familiar. Unlike updates to several ISO standards this year, the structure of EN ISO 13485:2016 is not aligned with ISO 9001:2015, because the two standards were developed in parallel. Its alignment instead follows ISO 9001:2008.