Guidance documents

Please select the resource you are interested in:

  • BSI product guidance documents
  • Medical Device Guidance (MEDDEV's) - Official guidance documents produced by the European Commission
  • Medical Device Notified Body Recommendations (NB-Med's) - Recommendations on the Directives from the European Notified Bodies Medical Devices Group
  • Consensus Statements - Agreed interpretations from the European Notified Bodies Medical Devices Group
  • Code of Conduct for Notified Bodies - The Code of Conduct addresses concerns expressed in the EU by the European Commission, Member States and trade representatives regarding consistency and competency of Notified Bodies.
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