Two key ISO/TC 210 standards have recently been harmonized in the European Union. The reference to EN ISO 13485:2016 and EN ISO 15223-1:2016 where both published in the Official Journal of the European Union on Friday, 17 November 2017.
Two key ISO/TC 210 standards have recently been harmonized in the European Union. The reference to EN ISO 13485:2016 and EN ISO 15223-1:2016 where both published in the Official Journal of the European Union on Friday, 17 November 2017. Both standards are now harmonized under the Medical Device (MDD), the Active Implant Medical Device (AIMD) and the In Vitro Diagnostic (IVDMD) directives.
To read the complete citation from the Official Journal, go to the following European sites:
- MDD (http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/)
- AIMD (http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices/)
- IVDMD (http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/)
EN ISO 13485:2016 will supersede the presumption of conformity of EN ISO 13485:2012 on 31 March 2019.
EN ISO 15223-1:2016 will supersede the presumption of conformity of EN 980:2008 on 31 December 2017.