EN ISO 13485:2016 - The harmonized standard is here

ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of 'cessation of presumption of conformity' of EN ISO 13485:2012 stated as 31 March 2019.

Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. Manufacturers that hold CE certification with BSI to allow them to place devices on the market in Europe (but do not hold separate ISO 13485 certification) will be assessed to EN ISO 13485:2016 from 1 April 2019. Manufacturers holding only ISO 13485 certification with BSI are required to transition to ISO 13485:2016/EN ISO 13485:2016 by 28th February, 2019.


The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in three and five years, respectively. You can find out more about the standard's harmonization in our recent blog post.


BSI can now offer UKAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. Talk to us to find out more.


Transition Training courses for ISO 13485:2016

We use accelerated learning techniques to make sure you fully understand the new ISO 13485:2016 and we put your learning into context with a blend of classroom teaching, workshops and interactive sessions.



Pre-Certification Gap Analysis

While you prepare for certification, BSI can carry out an optional Gap Analysis – also called a Pre-Certification Assessment. During this assessment, the existing processes and procedures within your organization are compared with the requirements of the standard. This identifies any potential oversights or weaknesses so that you can take immediate action, ahead of the audit process.

Want to find out more?

If you're an existing client, talk to us to arrange your gap analysis.

Not with BSI? Discuss your needs with our team.