In our online library, you will find a col­lec­tion of links to use­ful resources on the Euro­pean med­ical devices leg­is­la­tion and asso­ci­at­ed top­ics, like guid­ance and leg­is­la­tion doc­u­ments, fact­sheets, list of noti­fied bod­ies, Euro­pean author­i­ties web­sites etc. 

Links to our five main library sections

Please use the fol­low­ing links to enter each top­ic with a wide range of doc­u­ments, web­sites, infor­ma­tion and hints.

  1. Down­load Sec­tion Leg­is­la­tion Documents
  2. Down­load Sec­tion Guid­ance Doc­u­ments MDR
  3. Down­load Sec­tion Guid­ance Doc­u­ments IVDR
  4. Sup­port­ive Infor­ma­tion for Man­u­fac­tur­ers of Med­ical Devices and In Vit­ro Diagnostics
  5. Com­plete Link Sec­tion for Man­u­fac­tur­ers of Med­ical Devices and In Vit­ro Diagnostics

Although mdi Europa is con­stant­ly review­ing this sec­tions, please be aware that we list­ed only the most impor­tant doc­u­ments and links. Should you require a spe­cif­ic infor­ma­tion that is not list­ed, please get in touch with us.

To reach out for even more infor­ma­tion, browse all arti­cles on the mdi Europa web­site by keywords

BfArM (6) Brex­it (19) Case Study (2) CE Mark­ing (2) Check­lists (3) Clin­i­cal Eval­u­a­tion (11) COVID-19 (17) Down­load Sec­tion (2) EU Autho­rized Rep­re­sen­ta­tive (5) EUDAMED (16) Euro­pean Com­mis­sion (50) Fea­tured Con­tent (2) Guid­ance Doc­u­ments (67) IVDD (4) IVDR (105) Lega­cy Devices (20) Leg­is­la­tion Doc­u­ments (11) MDCG (41) MDD (3) MDR (124) Med­ical Devices (5) News in Brief (38) No-Deal Brex­it (9) Noti­fied Body (17) Per­for­mance Eval­u­a­tion (5) Secu­ri­ty Advice (5) Tem­plates (2) UDI (5) Unique Device Iden­ti­fi­ca­tion (4) Vig­i­lance (4)