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.
- Download Section Legislation Documents
- Download Section Guidance Documents MDR
- Download Section Guidance Documents IVDR
Download Section Legislation Documents
- MDR – Medical Devices Regulation (EU) 2017/745
PDF file MDR [1000 KB] - IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
PDF file IVDR [1000 KB] - AIMDD – Active Implantable Medical Devices Directive
PDF pdf file AIMDD [158 KB] - MDD – Medical Devices Directive
PDF file MDD [256KB] - IVDD – In Vitro Diagnostic Medical Devices Directive
PDF file IVDD [210 KB] - EMC – Electromagnetic Compatibility Directive
PDF file EMC [898 KB] - LVD – Low Voltage Directive
PDF file LVD [823KB] - WEEE – Waste Electrical and Electronic Equipment Directive No. 2012/19/EU
PDF file WEEE [978 KB] - RoHS – Restriction of Hazardous Substances
PDF file RoHS [891 KB]
Download Section Guidance Documents MDR
- Factsheet for Manufacturers of Medical Devices
PDF file Factsheet for MD Manufacturers [216 KB] - Implementation Model for Medical Devices Regulation
PDF Implementation Model [85 KB] - Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations
PDF file EU-Regulation ‘Manufacturers Obligations’ [757 KB] - Basic UDI-DI and UDI-DI Attributes
PDF file Basic UDI-DI and UDI-DI [259KB] - Basic UDI-DI and Changes to UDI-DI
PDF file Basic UDI-DI and Changes to UDI-DI [333 KB] - UDI Core Elements
PDF file UDI Core Elements [278 KB] - UDI FAQs
PDF file faqs_udi_system [429] - Person Responsible for Regulatory Compliance
PDF file Person responsible for Regulatory Compliance [81 KB] - Implant Card
PDF file Implant Card [504 KB] - MEDDEV 2.7/1, rev. 4 on Clinical Evaluations
PDF file MEDDEV 2.7/1 [631 KB] - Summary of Safety and Clinical Performance (SSCP)
PDF file Summary of Safety and Clinical Performance [139 KB] - Guidance on Qualification and Classification of Software
PDF file Guidance on Qualification and Classification of Software [274 KB] - Explanatory Note on MDR Codes
PDF Explanatory Note on MDR Codes [180 KB] - Guidance on Sampling of MDR and IVDR Devices
PDF file Guidance on Sampling of MDR and IVDR Devices [359 KB] - Guidance Notes for Manufacturers of Class I Medical Devices
PDF file Guidance Notes for Manufacturers of Class I Medical Devices [190 KB] - Guidance on Cybersecurity for Medical Devices
PDF file Guidance on Cybersecurity for Medical Devices [2000 KB]
Download Section Guidance Documents IVDR
- Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
PDF file Factsheet for IVD Manufacturers [362 KB] - Implementation Model for In Vitro Diagnostic Medical Devices Regulation
PDF file Implementation Model [86 KB] - Basic UDI-DI and UDI-DI Attributes
PDF file EU-Regulation ‘Manufacturers Obligations’ [221 KB] - Basic UDI-DI and Changes to UDI-DI
PDF file Basic UDI-DI and Changes to UDI-DI [333 KB] - UDI Core Elements
PDF file UDI Core Elements [287 KB] - UDI FAQs
PDF file FAQs UDI System [429] - Person Responsible for Regulatory Compliance
PDF file Person responsible for Regulatory Compliance [81KB] - Guidance on Qualification and Classification of Software
PDF file Guidance on Qualification and Classification of Software [274 KB] - Guidance on Sampling of MDR and IVDR Devices
PDF file Guidance on Sampling of MDR and IVDR Devices [359 KB] - Guidance on Cybersecurity for Medical Devices
PDF file Guidance on Cybersecurity for Medical Devices [2000 KB]
Find extensive information on this site and beyond
Supportive information section regarding the MDR / IVDR
Link section of the mdi Europa library