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Borderline and classification issues

Medical Devices Expert Group on Borderline and Classification

Non-exhaustive list of judgements rendered by the European Court of Justice

Other useful guidance

  • MEDDEV Guidance
  • EMEA recommendationpdf [219 KB] on the procedural aspects and dossier requirements for the consultation to the EMEA by a Notified Body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device.