Sep 5, 2012

There are big changes in the world of European Norm harmonized standards! On August 30, EN ISO 13485:2003 and EN ISO 14971:2009 were superseded by the 2012 versions pursuant to the publication of the Official Journal of the European Union. To demonstrate compliance with these harmonized standards, medical device manufacturers must now comply with EN ISO 13485:2012 and EN ISO 14971:2012. EN 980:2008 has yet to be superseded by EN ISO 15223-1:2012 in regard to medical device labelling and the use of symbols, but this is expected to occur shortly. Read more about additional superseded standards in the Official Journal of the European Union.

As a reminder, the “RoHS” Directive 2011/65/EU will bring medical devices and IVD devices into its purview in the coming years. This Directive restricts the use of certain hazardous substances in electrical and electronic equipment and will apply to medical devices and IVD devices, beginning 22 July 2014 and 22 July 2016, respectively. After these deadlines, CE marking affixed to medical devices or IVD devices subject to the RoHS Directive will imply compliance with this Directive. It appears that some Notified Bodies will prefer one Declaration of Conformity (DoC). Thus, a manufacturer’s current DoC would need to be updated to reflect compliance with both the RoHS Directive and the MDD/IVDD. We further understand that Notified Bodies are still discussing the extent to which they will verify compliance with the RoHS Directive.

Directive 2012/19/EU on waste electrical and electronic equipment (WEEE Directive) has been recast and published in the Official Journal of the European Union on 24 July 2012. From 15 August 2018 and onward, all electrical and electronic equipment will be classified within the six categories set out in Annex III of the WEEE Directive. Medical devices will then likely fall in categories 4 or 5: “large” or “small equipment”, respectively. The WEEE Directive also requires that a producer located outside a Member State’s territory appoint an Authorized Representative.


  • Stewart Eisenhart