Harmonized Standards to MDD Updated

The EU updated the list of MDD Harmonized Standards on May 13, 2011.

The two most commonly cited standards did not change.

EN ISO 13485:2003/AC:2009 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 14971:2009 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Some of the items marked new include:

EN ISO 8835-3:2009/A1:2010 Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates

EN 60601-2-52:2010 Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

The list of harmonized standards is available at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm