New lists of harmonized standards for medical devices published by EU Commission

On August 30th 2012, The EU Commission released 3 new lists of EU Harmonized Standards for medical devices under the Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC).

Complying with EU Harmonized Standards normally indicates a presumption of conformity with the essential requirements of the applicable EC Directives. Therefore, such standards serve as a fundamental tool in reference to creating technical documentations, obtaining the CE marking and having medical devices able to freely circulate in the European market.

The EU Commission has not provided a transition period between the old and new standards – this is due to the fact that the normative sections of these standards (containing the requirements to be complied with) have not been amended. On the other hand, the informative parts of the standards, which specify how the standards should be implemented to cover the conformity assessment procedures within the medical devices Directives, have been amended and should be implemented by medical device manufacturers.

Some important updates include (but are not limited to):

  • A new version of EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes (replacing EN ISO 13485:2003)
  • A new version of EN ISO 14971:2012 Medical devices – Application of risk management to medical devices (replacing EN ISO 14971:2009)
  • An up–date to EN 1865-3:2012, EN 1865-4:2012, EN 1865-5:2012 regarding patient handling equipment used in road ambulances
  • An up-date to EN ISO 11137-2:2012 regarding sterilization of health care products – radiation
  • An up-date to EN 60601-2-33:2002 on medical electrical equipment: particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  • An up-date to EN ISO 25539-1:2009 and EN ISO 25539-2:2009 regarding cardiovascular implants

Therefore, following the publication of August 30th 2012, it is recommended for manufacturers to contact their Notified Body and/or European Authorised Representative (EAR) and inquire as to any necessary actions towards their technical documentations.

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