On May 16, 2014 the EU Commission has published some new / updated harmonized standards for the 93/42/EEC (MDD).
Product, which conform to harmonized standards, are presumed to comply with the essential requirements in the Medical Device Directives.
The updates of horizontal standards, include a.o.:
|EN ISO 11137-1:2006/A1:2013||Sterilization of health care products – Radiation||2014-11-30|
|EN ISO 11137-2:2013||Sterilization of health care products – Radiation||2014-11-30|
|EN ISO 13408-1:2011/A1:2013||Aseptic processing of health care products||2014-11-30|
|EN 60601-1:2006/A1:2013||Medical electrical equipment||2017-12-31|
All harmonized standards you find here: