Harmonized Standards to MDD Updated

The EU updated the list of MDD Harmonized Standards on August 19, 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:

  • Parts of EN ISO 13408 Aseptic processing of health care products
  • Parts of EN 13976 Rescue systems – Transportation of incubators

You can read the full list of harmonized standards at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm