Ombu Enterprises LLC Ombu Enterprises LLC   
 
 
 
  Harmonized Standards Update - Nov. 2017

The EU has updated the list of standards harmonized to MDD. The list, published on November 17, 2017, is available at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

 

The list includes EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016. The presumption of conformity to EN ISO 13485:2012 ends on March 31, 2019. Accompanying note says, “The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation”.

 

 

 

 

 
 
 
 
© 2017 All Rights Reserved.