Harmonisation of medical device and IVD standards
European regulators have updated the harmonised standards for medical devices and in-vitro diagnostic (IVD) products, which were last updated in May 2016. The updated list of standards replaces the EN 980 labelling standard with EN ISO 15223 starting in early 2018.
The lists can be found here:
- Medical Devices Directive (MDD)
- Active implantable medical devices directive (AIMDD)
- In-vitro diagnostics directive (IVDD)
For the MDD, medical device companies should be aware of the following changes:
- EN 980:2008 pertaining to symbols used in medical device labels no longer applies
- EN ISO 15223-1:20126 replaces EN 980:2008 beginning January 1, 2008
- EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only)
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.
