ISO 13485 – Medical devices

The UNI EN ISO 13485:2004 International Standard regards the medical device industry and specifies the requirements for the quality management system of organisations active in designing and manufacturing medical devices and those that design and provide related services.
At European level EN ISO 13485:2003 has a status of harmonised standard for directives regulating the sector, such as directive 98/79/EC which concerns in vitro medical-diagnostic devices and new directive 2007/47/EC, issued on 5.9.2007, amending directives 90/385/EEC “active implantable medical devices”, 93/42/EEC “medical devices” and 98/8/EC “biocidal products”.
Standard UNI EN ISO 13485:2004 follows the scheme of standard ISO 9001 to promote harmonisation of regulatory requirements of medical devices with quality management systems.
Standard UNI EN ISO 13485:2004 concerns:

  • manufacturers of devices subject to CE Marking (all classes of MD);
  • suppliers of special processes associated to manufacture of devices (sterilisation, storage, transport);
  • companies that distribute and market medical products;
  • companies that provide services related to the devices (Installation, maintenance and repair, clinical engineering).

The advantages of UNI EN ISO 13485 certification:

  • for manufacturers of Medical Devices, EN ISO 13485:2003 certification offers the assumption of conformity of the quality system in case of assessment of the requirements to affix CE Marking conducted by Notified Body;
  • for manufacturers of class I Medical Devices (self-certification), EN ISO 13485:2003 certification assures direct and independent assessment on activities arranged to meet the requirements of directive 47/2007 and to prepare for any market vigilance activities carried out by the Ministry of Health;
  • for companies that distribute or market medical products and for companies that provide services related to the devices, UNI EN ISO 13485 certification makes it possible to bid for tenders published by the P.A.

ICIM is accredited by ACCREDIA for UNI EN ISO 13485 certification

ICIM, having passed the audit by the Commission, is the first certification body in Italy that has received from the Ministry of Health renewal and extension of the authorisation to issue CE marking for medical devices according to the new EU regulation and it is among notified bodies on the Ministry of Health’s website and in the list of notified bodies in Europe.

To know the categories of products for which ICIM is a notified body, see NANDO – New Approach Notified and Designated Organisations

For further information: Vanda Spina (phone +39 02 72534204, e-mail vanda.spina@icim.it)

To find out about other related certification services: