MEDDEV

The European Commission provides a range of guidance documents called MEDDEV Guidances to assist stakeholders in implementing directives related to medical devices:

  • Directive on active implantable medical devices 90/385/EEC (AIMD)
  • Directive concerning medical devices 93/42/EEC (MDD)
  • Directive on in-vitro diagnostic medical devices 98/79/EEC (IVDD)

Link to MEDDEV Guidances

MDCG

The European Commission provides a range of guidance documents called MDCG Guidances to assist stakeholders in implementing regulations related to medical devices:

Link to MDCG Guidances