Borderline and classification issues

Medical Devices Expert Group on Borderline and Classification

• List of Members of the MDEG on Borderline and Classification(91 KB)
• Manual on borderline and classification in the Community Regulatory framework for medical devices
  (233 KB)(version 1.12 of 04-2012)

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

• Cosmetic products sector
• Pharmaceutical sector
  • Definition of medicinal products(56 KB)
  • Other Pharmaceutical related issues

Other useful guidance

• Manual on the scope of application of the cosmetics Directive 76/768/EEC(64 KB)
• Guidance on the relationship between the GPSD and certain sector Directives with provisions on product safety
• Guidance for the biocidal products Directive 98/8/EC and for the cosmetics Directive 76/768/EEC
• Manual of decisions for implementation of biocidal Directive 98/8/EC
• Guidance on the demarcation between cosmetics Directive 76/768/EEC and medicinal products Directive 2001/83/EC(60 KB)

• MEDDEV Guidance
• EMEA recommendation 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.