European Union Updates List of Standards for Medical Device Directives
European officials have published an updated list of recognized and harmonized standards in the Official Journal of the European Union, including standards pertaining to their medical device and IVD Directives.
The first 50 pages of the new list deal with the Medical Devices Directive, In Vitro Diagnostics Directive and Active Implantable Medical Device Directive.
In addition, European regulators have included several standards for the first time that have relevance to some medical device and IVD manufacturers. The standards published for the first time include:
- EN ISO 11990-1:2014 and EN ISO 11990-2:2014 pertaining to laser resistance of tracheal tubes
- ISO 10993-3:2014 pertaining to genotoxicity, carcinogenicity and reproductive and developmental toxicity
- EN 13060:2014 on steam sterilizers
- EN 13748-2:2015 on air ambulances
- EN 60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 on general safety electrical equipment
These standards play a major role in CE Marking certification and compliance in Europe, so manufacturers active in the EU or considering commercializing there should be aware of the new list.