The Medical Devices Introductory Course 2020

What is EN ISO 13485: 2016?

• It is a European standard. It is the European version of ISO 13485. • It is the current version of EN ISO 13485. The previous version was dated 2012. • It is a harmonised standard (it is included in the list of harmonised standards published in the EU OJ). • It is the harmonised standard for QMSs for medical devices. • The normative content of ISO 13485 and EN ISO 13485 are the same.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Significance of EN ISO 13485

• EN ISO 13485 supplements the Conformity Assessment annexes by specifying the requirements in more detail • The correspondence between the Conformity Assessment annexes of the MDD and the various clauses of the standard is given in Annex ZB of the standard. • To demonstrate compliance NB assessment and certification is required. • For the purpose of CE marking a NB will issue an EC certificate (not a EN ISO 13485 certificate).

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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