Complete Link Section mdi Europa

The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find an up to date collection of useful links to important details on crucial topics like the new the Regulations MDR and IVDR, Brexit and other related themes. This list will be refreshed and extended regularly.

  1. European Link Section MDR / IVDR
  2. European Link Section Brexit
  3. European Link Section MDD / IVDD
  4. European Link Section Miscellaneous
  5. US and Canadian Link Section
  6. General Information Link Section
  7. News Link Section
  1. Regulatory framework – Comprehensive details published by the European Commission about the MDR and IVDR
    Visit website ec.europa.eu, section Regulatory Framework
  2. Guidance documents – Guidance documents published by the European Commission on the MDR and IVDR
    Visit website ec.europa.eu, section New Regulations Guidance
  3. EUDAMED – European Commission website on EUDAMED under the MDR and IVDR
    Visit website ec.europa.eu, section New Regulations EUDAMED
  4. List of Notified Bodies under the MDR
    Visit website ec.europa.eu, section New Regulations, Notified Bodies
  5. List of Notified Bodies under the IVDR
    Visit website ec.europa.eu, section Notified Bodies Nando

  1. European Website on Brexit
    Visit website ec.europa.eu, section Brexit Info
  2. UK Website on Brexit
    Visit website gov.uk, section Brexit in a No-Deal event
  1. List of Notified Bodies under the MDD
    Visit website ec.europa.eu, section Notified Bodies under MDD
  2. List of Notified Bodies under the IVDD
    Visit website, ec.europa.eu, section Notified Bodies under IVDD
  3. List of Harmonized Standards for the MDD
    Visit website ec.europa.eu, section Harmonized Standards for the MDD
  4. List of Harmonized Standards for the IVDD
    Visit website ec.europa.eu, section Harmonized Standards for the IVDD
  1. List of Competent Authorities
    Visit website ec.europa.eu, section Contacts Medical Devices
  2. Bfarm – German Federal Institute for Drugs and Medical Devices
    Visit website www.bfarm.de, section Medical Devices
  3. European Union Homepage
    Visit website europa.eu, section European Union
  4. IMDRF Homepage – International Medical Device Regulators Forum, former GHTF
    Visit website imdrf.org
  5. MedTech Europe – European trade association for medical technology, former EUCOMED and EDMA
    Visit website medtecheurope.org
  6. International Organization for Standardization
    Visit website iso.org
  7. Publisher of European standards
    Visit website beuth.de
  1. FDA – Food and Drug Administration – U.S. Department for Health and Human Services
    Visit website fda.gov, section Medical Devices
  2. CDRHNew – FDA website on news and events related to medical devices
    Visit website fda.gov, section News & Events Medical Devices
  3. Health Canada – Canadian Regulatory Body on Medical Devices
    Visit website canada.ca, section Regulatory Body on Medical Devices
  4. RAPS – Regulatory Affairs Professional Society
    Visit website www.raps.org
  1. Health Finder – Useful links, with search function
    Visit website healthfinder.gov
  2. Healio – Listings and useful links
    Visit website www.healio.com
  3. Health Monitoring System – Information system of the German federal health monitoring
    Visit website gbe-bund.de, section Information System German Health Monitoring
  4. Onmeda – Information and German links with a search engine (german language!)
    Visit website www.onmeda.de
  1. MedTech Insight – Worldwide diagnostic and medical device news
    Visit website medtech.pharmaintelligence.informa.com
  2. British Medical Journal – Extensive archive with search functions
    Visit website www.bmj.com
  3. CNN Health – News and stories
    Visit website edition.cnn.com, section Health