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EU Updates for Harmonized Standards for Medical Devices and In-Vitro Diagnostic (IVD) Products

The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).

This was last updated in May 2016 and will affect the following standards:

Medical Device Directive (MDD)

 Active Implantable Devices Directive (AIMDD) 

In Vitro Diagnostic Devices Directive (IVDD)

The harmonisation process of these standards was stalled in May 2016 but it appears it has been revamped up. We speculate this is due to the UK not adopting the EU MDR and IVDR in favour of keeping the current standard.

Changes medical device companies should be aware of are:

  • EN 980:2008 pertaining to symbols used in medical device labels no longer applies
  • EN ISO 15223-1:2016 replaces EN 980:2008 beginning January 1, 2018
  • EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only)

For further information, the chance to talk to our experts or view our products which support medical device companies please reach out to us on [email protected] or call the team on +44 1244 287 900.



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