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
  6. List of har­mo­nized stan­dards for the MDR
    Vis­it web­site ec.europa.eu, sec­tion Har­mo­nized Stan­dards, Med­ical Devices
  7. List of har­mo­nized stan­dards for the IVDR
    Vis­it web­site ec.europa.eu, sec­tion Har­mo­nized Stan­dards, In Vit­ro Diag­nos­tic Med­ical Devices
  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