Ancillary medicinal substances: Regulatory and procedural guidance

Here you can find practical information and guidance documents for the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device.

Directives

• Council Directive 93/42/EEC on Medical Devices
• Directive 2000/70/EC amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
• Directive 2001/104/EC amending Council Directive 93/42/EEC concerning Medical Devices
• Consolidated text of Directive 93/42/EEC as amended
  Note: Consolidation entails the integration of basic instruments of Community legislation, their amendments and corrections in single, non-official documents. Each document is intended for use as a documentation tool and the Institutions do not assume any liability for its content.
• Directive 2007/47/EC amending Council Directive 90/385/EEC, Council Directive 93/42/EEC and Directive 98/8/EC
• Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EE)
• Medical Devices Legislation on the DG Enterprise website

Guidelines

Related links

• Medical Devices Guidance document MEDDEV 2.1/3 rev 3
• Overview of CHMP Opinions on Consultation Procedure