Reference documents

1. Legislation

Current legislation:

• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

Classification:

• Reclassification of hip, knee and shoulder joint replacements:
  - Directive 2005/50/EC - OJ L 210/41 of 12/08/2005
• Reclassification of breast implants:
  - Directive 2003/12/EC - OJ L 28/43 of 4.02.2003

Other amending and implementing legislation:

• Electronic instructions for use of medical devices
  - Commission Regulation (EU) No 207/2012  - OJ L72 of 10.03.2012
• MD manufactured utilising tissues of animal origin:
  - Commission Regulation (EU) No 722/2012 - OJ 212/3 of 9.08.2012
  - Directive 2003/32/EC - OJ L105/18 of 26.04.2003
• Variant Creutzfeld-Jakob Disease assays:
  - Commission Directive 2011/100/EU - OJ L341/50 of 22.12.2011
• Common Technical Specification on IVD:
  - Commission Decision 2011/869/EU - OJ L341/63 of 22.12.2011
  - Commission Decision 2002/364/EC - OJ L131/17 of 16.05.2002
  - Commission Decision 2009/886/EC - OJ L318/25 of 14.12.2009
  - Corrigendum to Commission Decision 2009/886/EC - OJ L 348/94 of 29.12.2009
• Eudamed - European Databank on Medical Devices:
  - Commission Decision 2010/227/EU - OJ L102/45 of 23.04.2010

2. Guidance

• MEDDEV: Guidelines relating to medical device Directives

3. Consensus statements

• Consensus Statements

4. Interpretative documents

• Interpretative documents

5. Standards

• Harmonised Standards
• CEN monthly Snapshot