About quality management systems, risk management and terminology for medical devices

BSI British Standards participates in the area of quality management systems, risk management and terminology for medical devices as the UK representative on the international committee ISO/TC 210 and its working groups. Current work involves:

  • Providing UK input into the efforts at coordinating the work of ISO/TC210 and the Global
  • Harmonization Task Force (GHTF), which has similar objectives.
  • Providing UK input into the work on software lifecycle processes for medical device software
  • Providing UK input into the work on application of usability engineering to medical devices
  • Contributing to the work to align ISO and CEN standards on symbols for medical devices.

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

  • Active Implantable Medical Devices (AIMDD) Council Directive 90/385/EEC (1990)
  • Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992)
  • In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).

For the latest versions of all Directives, visit the Directives List on the website of New Approach Standardisation in Europe www.newapproach.org.

Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) amended by (2007/47/EC)

An amendment (2007/47/EC) was published in 2007 by the European Commission. Two of the three current Directives applicable to Medical Devices have been updated. As a result over 100 published European standards have been affected. These standards are currently being updated with reference to the amended Directive and, where applicable, to include any new technical requirements.

All of these updated standards are due to be published by 31 October 2009, in consolidated from, revised and updated.

It is important that manufacturers have the latest versions of the standards relating to medical devices, in order to continue compliance with the amended Directive.

Medical device clinical evaluation guidelines are published by the European Commission

The guidelines aim to promote a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health. The guidelines cover the essential requirements, classification and conformity assessment of medical devices. They also cover products using materials of biological origin, In Vitro diagnostic medical devices and market surveillance.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, because of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Visit the Commission’s website to read more and download your copies. 

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