Standards


Many medical device and IVD manufacturers have adopted ISO 14001:2004, a voluntary certification standard which sets out criteria for an environmental management system. 

It is a part of the EU’s more-demanding Eco-Management and Audit Scheme (EMAS), which lays down rules on legal compliance and reporting duties. The particular ISO standard on risk management for medical devices is ISO 14971 which sets requirements to determine the safety of a medical device by the manufacturer during the product lifecycle.

Smaller companies will often adopt other environmental best practices when they lack the capacity to implement standards such as ISO 14001:2004 or prefer to develop their own strategies.