The Medical Devices Introductory Course 2020

Harmonised Standards Article 8.1 (MDD Article 5)

• Listed in the OJ of the EU • For the MDD the most recent listing was 24 March 2020. There are 264 harmonised standards. • For the MDR the most recent listing was 15 May 2020. There are 57 harmonised standards. • All are ENs or EN ISOs. • Compliance is voluntary • Compliance with harmonised standards gives automatic compliance with specified GSPR (presumption of conformity). • Each harmonised standard includes an Annex Z which lists the GSPRs covered by the standard.

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The Organisation for Professionals in Regulatory Affairs

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Horizontal & Vertical Standards

• Standards (including harmonised standards) can be horizontal or vertical • Horizontal standards are not-product specific and include standards for QMS (EN ISO 13485), risk analysis, clinical, biocompatibility, electrical safety, packaging, symbols, sterilisation, information, etc. Most of the 57 harmonised standards under the MDR are horizontal. • Vertical standards are product-specific • Hint: First, check the list of available harmonised standards and identify those that are applicable to your products. Then, where possible, demonstrate compliance.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

32