New harmonised medical device standards published in Europe

The European Commission has published updated harmonised standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). 

The European list of harmonised standards was last updated in May 2016 and the latest list of standards cover the Medical Devices Directive (MDD), Active Implantable Devices Directive (AIMDD) and In Vitro Diagnostic Devices Directive (IVDD).

A key point is that the updated list of standards replaces the EN 980 labelling standard with EN ISO 15223 starting in early 2018.

For the MDD, medical device companies should be conscious of the following changes:

  • EN 980:2008 pertaining to symbols used in medical device labels no longer applies.
  • EN ISO 15223-1:2016 replaces EN 980:2008 beginning January 1, 2018.
  • EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only).

The updated list of standards does not directly apply to the forthcoming Medical Devices Regulation (MDR) or In-vitro Diagnostics Regulation (IVDR), however no significant differences regarding the relevance of these standards are likely to arise once the new regulations are in place.

Medical device and IVD manufacturers CE Mark certified to sell their products in Europe should also familiarize themselves with updates to various standards that apply to each of the three Directives.

To view the new harmonised medical device standards, please click here.