Regulatory update : European Standard

European Standard EN 16844:2017+A2 (August 2019)

The European Standard EN 16844:2017+A2 defines the set of requirements deemed essential for the delivery of aesthetic medicine services (non-surgical medical treatments).

This European Standard was adopted by the European Committee for Standardization (CEN) on December 20, 2017 and includes Amendment 2 adopted by CEN on April 16, 2019. In particular, the text specifies the risk level of treatments according to possible complications. The risk levels are defined as follows: 

• A Minimal risk (i.e., mild and transient signs/symptoms);
• B Mild impairment (i.e., moderate and transient signs/symptoms);
• C Cosmetic damage (i.e., permanent damage with no functional restriction);
• D Disability (permanent damage with functional restrictions);
• E Death.

This standard classifies platelet-rich plasma injections and comparable procedures, processed in a closed system (such as the Regenlab process) as Risk Level A (minimal risk) and platelet-rich plasma injections and comparable procedures, processed in an open system as Risk Level B.

Text of the standard EN 16844:2017+A2

Bruno BOEZENNEC, MD, Managing Editor