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 more than 50 impor­tant offi­cial doc­u­ments as down­loads to gain an overview of the applic­a­ble leg­is­la­tion and impor­tant guid­ance doc­u­ments. These are essen­tial for the imple­men­ta­tion of the Euro­pean med­ical devices legislation.

  1. Down­load Sec­tion Leg­is­la­tion Documents
  2. Down­load Sec­tion Guid­ance Doc­u­ments MDR
  3. Down­load Sec­tion Guid­ance Doc­u­ments IVDR

Down­load Sec­tion Leg­is­la­tion Documents

  1. MDR – Med­ical Devices Reg­u­la­tion (EU) 2017/745 – includ­ing Cor­ri­gen­dum and Amend­ment
    down­load file
  2. IVDR – In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 – includ­ing Cor­ri­gen­dum and Amend­ment
    down­load file
  3. Com­mon spec­i­fi­ca­tions for cer­tain class D in vit­ro diag­nos­tic med­ical devices in accor­dance with Reg­u­la­tion (EU) 2017/746
    down­load file
  4. AIMDD – Active Implantable Med­ical Devices Direc­tive
    down­load file
  5. MDD – Med­ical Devices Direc­tive
    down­load file
  6. IVDD – In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive
    down­load file
  7. PPE-R – Per­son­al Pro­tec­tive Equip­ment Reg­u­la­tion (EU) 2016/425
    down­load file
  8. EMC – Elec­tro­mag­net­ic Com­pat­i­bil­i­ty Direc­tive
    down­load file
  9. LVD – Low Volt­age Direc­tive
    down­load file
  10. WEEE – Waste Elec­tri­cal and Elec­tron­ic Equip­ment Direc­tive No. 2012/19/EU
    down­load file
  11. RoHS – Restric­tion of Haz­ardous Sub­stances
    down­load file

Down­load Sec­tion Guid­ance Doc­u­ments MDR

Please note that the doc­u­ments list­ed below are non-com­pre­hen­sive. A full list of avail­able guid­ance doc­u­ments can be accessed on the web­site of the Euro­pean Com­mis­sion and oth­er insti­tu­tions. You may also con­tact our team if you are look­ing for spe­cif­ic guidance.

Class I Devices

  1. Guid­ance Notes for Man­u­fac­tur­ers of Class I Med­ical Devices
    down­load file
  2. Class I Tran­si­tion­al pro­vi­sions under Arti­cle 120 of the MDR
    down­load file

Clas­si­fi­ca­tion and Borderline

  1. Guid­ance on Clas­si­fi­ca­tion of Med­ical Devices
    down­load file
  2. Guid­ance on bor­der­line between med­ical devices and med­i­c­i­nal prod­ucts under Reg­u­la­tion (EU) 2017/745 on med­ical devices
    down­load file
  3. Man­u­al on bor­der­line and clas­si­fi­ca­tion for med­ical devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices and Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices
    down­load file

Clin­i­cal Inves­ti­ga­tion and Evaluation

  1. MEDDEV 2.7/1, rev. 4 on Clin­i­cal Eval­u­a­tions
    down­load file
  2. Clin­i­cal Eval­u­a­tion – Equiv­a­lence
    down­load file
  3. Reg­u­la­tion (EU) 2017/745: Clin­i­cal evi­dence need­ed for med­ical devices pre­vi­ous­ly CE marked under Direc­tives 93/42/EEC or 90/385/EEC
    down­load file
  4. Safe­ty report­ing in clin­i­cal inves­ti­ga­tions of med­ical devices under the MDR
    down­load file
  5. Clin­i­cal eval­u­a­tion assess­ment report tem­plate
    down­load file
  6. Reg­u­la­tion (EU) 2017/745 – Ques­tions & Answers regard­ing clin­i­cal inves­ti­ga­tion
    down­load file
  7. Clin­i­cal inves­ti­ga­tion application/notification doc­u­ments
    down­load file
  8. COMMISSION GUIDANCE on the con­tent and struc­ture of the sum­ma­ry of the clin­i­cal inves­ti­ga­tion report
    down­load file
  9. Guid­ance on exemp­tions from the require­ment to per­form clin­i­cal inves­ti­ga­tions pur­suant to Arti­cle 61(4)-(6) MDR and on ‘suf­fi­cient lev­els of access’ to data need­ed to jus­ti­fy claims of equiv­a­lence
    down­load file

Eco­nom­ic Operators

  1. Ques­tions and Answers on Arti­cles 13 & 14 of Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746
    down­load file
  2. Guid­ance on Autho­rised Rep­re­sen­ta­tives
    down­load file

EUDAMED

  1. Man­age­ment of Lega­cy Devices under the MDR in EUDAMED
    down­load file
  2. Guid­ance on har­monised admin­is­tra­tive prac­tices and alter­na­tive tech­ni­cal solu­tions until EUDAMED is ful­ly func­tion­al
    down­load file

Euro­pean Med­ical Device Nomen­cla­ture (EMDN) 

  1. The Euro­pean Med­ical Device Nomen­cla­ture (EMDN)
    down­load file
  2. FAQ on the Euro­pean Med­ical Device Nomen­cla­ture (EMDN)
    down­load file

New Tech­nolo­gies

  1. Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware
    down­load file
  2. Guid­ance on Cyber­se­cu­ri­ty for Med­ical Devices
    down­load file
  3. Guid­ance on Clin­i­cal Eval­u­a­tion (MDR) / Per­for­mance Eval­u­a­tion (IVDR) of Med­ical Device Soft­ware
    down­load file
  4. Med­ical Device Soft­ware (MDSW) – Hard­ware com­bi­na­tions Guid­ance on MDSW intend­ed to work in com­bi­na­tion with hard­ware or hard­ware com­po­nents
    down­load file

Noti­fied Bodies

  1. Explana­to­ry Note on MDR Codes
    down­load file
  2. Guid­ance on Sam­pling of MDR and IVDR Devices
    down­load file
  3. Guid­ance on sig­nif­i­cant changes regard­ing the tran­si­tion­al pro­vi­sion under Arti­cle 120 of the MDR
    down­load file
  4. Guid­ance for noti­fied bod­ies on the use of MDSAP audit reports car­ried out under the MDR and IVDR
    down­load file

Post-Mar­ket Sur­veil­lance (PMS)

  1. Post-mar­ket clin­i­cal fol­low-up (PMCF) Plan Tem­plate
    down­load file
  2. Post-mar­ket clin­i­cal fol­low-up (PMCF) Eval­u­a­tion Report Tem­plate
    down­load file
  3. MDCG 2022-21 Guid­ance on Peri­od­ic Safe­ty Update Report (PSUR) Accord­ing to Reg­u­la­tion (EU) 2017/745 (MDR)
    down­load file
  4. Ques­tions and Answers on vig­i­lance terms and con­cepts as out­lined in the Reg­u­la­tion (EU) 2017/745 on med­ical devices
    down­load file
  5. Guid­ance on the vig­i­lance sys­tem for CE-marked devices
    down­load file
  6. Guid­ance on the vig­i­lance sys­tem for CE-marked devices – Devices for Car­diac Abla­tion
    down­load file
  7. Guid­ance on the vig­i­lance sys­tem for CE-marked devices – Coro­nary Stents and asso­ci­at­ed deliv­ery sys­tems
    down­load file
  8. Guid­ance on the vig­i­lance sys­tem for CE-marked devices – Car­diac Implantable Elec­tron­ic Devices (CIEDs)
    down­load file
  9. Guid­ance on the vig­i­lance sys­tem for CE-marked devices – Breast Implants
    down­load file

Annex XVI Devices

  1. Guid­ance on qual­i­fi­ca­tion and clas­si­fi­ca­tion of Annex XVI Prod­ucts
    down­load file
  2. Guid­ance on demon­stra­tion of equiv­a­lence for Annex XVI prod­ucts
    down­load file

Oth­er Topics

  1. Fact­sheet for Man­u­fac­tur­ers of Med­ical Devices
    down­load file
  2. Fact­sheet for author­i­ties in non-EU/EEA states on med­ical devices and in vit­ro diag­nos­tic med­ical devices
    down­load file
  3. Imple­men­ta­tion Mod­el for Med­ical Devices Reg­u­la­tion
    down­load file
  4. Imple­men­ta­tion of Med­ical Devices EU-Reg­u­la­tion – Focus on Man­u­fac­tur­ers’ oblig­a­tions
    down­load file
  5. Per­son Respon­si­ble for Reg­u­la­to­ry Com­pli­ance
    down­load file
  6. Implant Card
    down­load file
  7. Sum­ma­ry of Safe­ty and Clin­i­cal Per­for­mance (SSCP)
    down­load file
  8. Ques­tions and Answers on Cus­tom-Made Devices
    down­load file
  9. Guid­ance on stan­dard­i­s­a­tion for med­ical devices
    down­load file
  10. Guid­ance on Implant Card – Device types
    down­load file
  11. Reg­u­la­tion (EU) 2017/745 – appli­ca­tion of MDR require­ments to ‘lega­cy devices’ and to devices placed on the mar­ket pri­or to 26 May 2021 in accor­dance with Direc­tives 90/385/EEC or 93/42/EEC
    down­load file
  12. MDCG Posi­tion Paper on the  appli­ca­tion of Arti­cle 97 MDR to lega­cy devices for which the MDD or AIMDD cer­tifi­cate expires before the issuance of a MDR cer­tifi­cate
    down­load file
  13. Q&A on prac­ti­cal aspects relat­ed to the imple­men­ta­tion of Reg­u­la­tion (EU) 2023/607 amend­ing Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746
    down­load file
  14. MDR – lan­guage require­ments for man­u­fac­tur­ers
    down­load file

Unique Device Iden­ti­fi­ca­tion (UDI)

  1. Basic UDI-DI and UDI-DI Attrib­ut­es
    down­load file
  2. Basic UDI-DI and Changes to UDI-DI
    down­load file
  3. UDI Core Ele­ments
    down­load file
  4. UDI FAQs
    down­load file
  5. Posi­tion Paper on the Imple­men­ta­tion of UDI  require­ments for con­tact lens­es, spec­ta­cle frames, spec­ta­cle lens­es & ready read­ers
    down­load file
  6. The sta­tus of Appen­dix­es E-I of IMDRF N48 under the EU reg­u­la­to­ry frame­work for med­ical devices
    down­load file
  7. Guid­ance note inte­gra­tion of the UDI with­in an organisation’s qual­i­ty
    down­load file
  8. Ques­tions and  Answers on the Unique Device Iden­ti­fi­ca­tion sys­tem under Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746
    down­load file

Down­load Sec­tion Guid­ance Doc­u­ments IVDR

Please note that the doc­u­ments list­ed below are non-com­pre­hen­sive. A full list of avail­able guid­ance doc­u­ments can be accessed on the web­site of the Euro­pean Com­mis­sion and oth­er insti­tu­tions. You may also con­tact our team if you are look­ing for spe­cif­ic guidance.

Clas­si­fi­ca­tion and Borderline

  1. Guid­ance on Clas­si­fi­ca­tion Rules for in vit­ro Diag­nos­tic Med­ical Devices under the IVDR
    down­load file
  2. Man­u­al on bor­der­line and clas­si­fi­ca­tion for med­ical devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices and Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices
    down­load file

COVID-19

  1. Guid­ance on per­for­mance eval­u­a­tion of SARS-CoV-2 in vit­ro diag­nos­tic med­ical devices
    down­load file

Eco­nom­ic Operators

  1. Ques­tions and Answers on Arti­cles 13 & 14 of Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746
    down­load file
  2. Guid­ance on Autho­rised Rep­re­sen­ta­tives
    down­load file

EUDAMED

  1. Man­age­ment of Lega­cy Devices under the MDR in EUDAMED
    down­load file
  2. Guid­ance on har­monised admin­is­tra­tive  prac­tices and alter­na­tive tech­ni­cal solu­tions until EUDAMED is ful­ly func­tion­al
    down­load file
  3. Guid­ance on har­monised admin­is­tra­tive prac­tices and alter­na­tive tech­ni­cal solu­tions until Eudamed is ful­ly func­tion­al for ivdr med­ical devices
    down­load file

Euro­pean Med­ical Device Nomen­cla­ture (EMDN) 

  1. The Euro­pean Med­ical Device Nomen­cla­ture (EMDN)
    down­load file
  2. FAQ on the Euro­pean Med­ical Device Nomen­cla­ture (EMDN)
    down­load file

New Tech­nolo­gies

  1. Guid­ance on Qual­i­fi­ca­tion and Clas­si­fi­ca­tion of Soft­ware
    down­load file
  2. Guid­ance on Cyber­se­cu­ri­ty for Med­ical Devices
    down­load file
  3. Guid­ance on Clin­i­cal Eval­u­a­tion (MDR) / Per­for­mance Eval­u­a­tion (IVDR) of Med­ical Device Soft­ware
    down­load file

Noti­fied Bodies

  1. Guid­ance on Sam­pling of MDR and IVDR Devices
    down­load file
  2. Guid­ance for noti­fied bod­ies on the use of MDSAP audit reports car­ried out under the MDR and IVDR
    down­load file

Oth­er Topics

  1. Fact­sheet for Man­u­fac­tur­ers of In Vit­ro Diag­nos­tic Med­ical Devices
    down­load file
  2. Fact­sheet for author­i­ties in non-EU/EEA states on med­ical devices and in vit­ro diag­nos­tic med­ical devices
    down­load file
  3. Imple­men­ta­tion Mod­el for In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion
    down­load file
  4. Per­son Respon­si­ble for Reg­u­la­to­ry Com­pli­ance
    down­load file
  5. Guid­ance on sig­nif­i­cant changes regard­ing the tran­si­tion­al pro­vi­sion under Arti­cle 110(3) of the IVDR
    down­load file
  6. Q&A on the inter­face between Reg­u­la­tion (EU) 536/2014 on clin­i­cal tri­als for med­i­c­i­nal prod­ucts for human use (CTR) and Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR)
    down­load file
  7. Guid­ance on the health insti­tu­tion exemp­tion under Arti­cle 5(5) of Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746
    down­load file
  8. Q&A on prac­ti­cal aspects relat­ed to the imple­men­ta­tion of Reg­u­la­tion (EU) 2023/607 amend­ing Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746
    down­load file
  9. IVDR – lan­guage require­ments for man­u­fac­tur­ers
    down­load file

Per­for­mance Eval­u­a­tion and Study

  1. Clin­i­cal Evi­dence Require­ments for CE cer­ti­fi­ca­tion under the IVDR (issued by MedTech Europe)
    down­load file
  2. Guid­ance on gen­er­al prin­ci­ples of clin­i­cal evi­dence for In Vit­ro Diag­nos­tic med­ical devices (IVDs)
    down­load file
  3. MDCG 2022-19 Per­for­mance study application/notification doc­u­ments under Reg­u­la­tion (EU) 2017/746
    down­load file
  4. Per­for­mance study application/notification doc­u­ments under Reg­u­la­tion (EU) 2017/746
    down­load file
  5. Sub­stan­tial mod­i­fi­ca­tion of  per­for­mance study under Reg­u­la­tion (EU) 2017/746
    down­load file

Unique Device Iden­ti­fi­ca­tion (UDI)

  1. Basic UDI-DI and UDI-DI Attrib­ut­es
    down­load file
  2. Basic UDI-DI and Changes to UDI-DI
    down­load file
  3. UDI Core Ele­ments
    down­load file
  4. UDI FAQs
    down­load file
  5. The sta­tus of Appen­dix­es E-I of IMDRF N48 under the EU reg­u­la­to­ry frame­work for med­ical devices
    down­load file
  6. Guid­ance note inte­gra­tion of the UDI with­in an organisation’s qual­i­ty
    down­load file
  7. Ques­tions and Answers on the Unique Device Iden­ti­fi­ca­tion sys­tem under Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746
    down­load file
  8. Reg­u­la­tion (EU) 2017/746 – appli­ca­tion of IVDR require­ments to ‘lega­cy devices’ and to devices placed on the mar­ket pri­or to 26 May 2022 in accor­dance with Direc­tive 98/79/EC
    down­load file
  9. Sum­ma­ry of safe­ty and per­for­mance Tem­plate
    down­load file