Complete Download 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 more than 20 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
    PDF file MDR [1000 KB]
  2. IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
    PDF file IVDR [1000 KB]
  3. AIMDD – Active Implantable Medical Devices Directive
    PDF pdf file AIMDD [158 KB]
  4. MDD – Medical Devices Directive
    PDF file MDD [256KB]
  5. IVDD – In Vitro Diagnostic Medical Devices Directive
    PDF file IVDD [210 KB]
  6. EMC – Electromagnetic Compatibility Directive
    PDF file EMC [898 KB]
  7. LVD – Low Voltage Directive
    PDF file LVD [823KB]
  8. WEEE – Waste Electrical and Electronic Equipment Directive No. 2012/19/EU
    PDF file WEEE [978 KB]
  9. RoHS – Restriction of Hazardous Substances
    PDF file RoHS [891 KB]

Download Section Guidance Documents MDR

  1. Factsheet for Manufacturers of Medical Devices
    PDF file Factsheet for MD Manufacturers [216 KB]
  2. Implementation Model for Medical Devices Regulation
    PDF Implementation Model [85 KB]
  3. Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations
    PDF file EU-Regulation ‘Manufacturers Obligations’ [757 KB]
  4. Basic UDI-DI and UDI-DI Attributes
    PDF file Basic UDI-DI and UDI-DI [259KB]
  5. Basic UDI-DI and Changes to UDI-DI
    PDF file Basic UDI-DI and Changes to UDI-DI [333 KB]
  6. UDI Core Elements
    PDF file UDI Core Elements [278 KB]
  7. UDI FAQs
    PDF file faqs_udi_system [429]
  8. Person Responsible for Regulatory Compliance
    PDF file Person responsible for Regulatory Compliance [81 KB]
  9. Implant Card
    PDF file Implant Card [504 KB]
  10. MEDDEV 2.7/1, rev. 4 on Clinical Evaluations
    PDF file MEDDEV 2.7/1 [631 KB]

Download Section Guidance Documents IVDR

  1. Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
    PDF file Factsheet for IVD Manufacturers [362 KB]
  2. Implementation Model for In Vitro Diagnostic Medical Devices Regulation
    PDF file Implementation Model [86 KB]
  3. Basic UDI-DI and UDI-DI Attributes
    PDF file EU-Regulation ‘Manufacturers Obligations’ [221 KB]
  4. Basic UDI-DI and Changes to UDI-DI
    PDF file Basic UDI-DI and Changes to UDI-DI [333 KB]
  5. UDI Core Elements
    PDF file UDI Core Elements [287 KB]
  6. UDI FAQs
    PDF file faqs_udi_system [429]
  7. Person Responsible for Regulatory Compliance
    PDF file Person responsible for Regulatory Compliance [81KB]

Find extensive information on this site and beyond

Supportive information section regarding the MDR / IVDR
Link section of the mdi Europa library