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.
- 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 – including Corrigendum
PDF file MDR [2000 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 [321 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 [164 KB] - UDI Core Elements
PDF file UDI Core Elements [278 KB] - UDI FAQs
PDF file Regulation Tool EU MDR IVDR [418] - Person Responsible for Regulatory Compliance
PDF file Person responsible for Regulatory Compliance [81 KB] - Implant Card
PDF file Implant Card [458 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] - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR
PDF file significant changes … under Article 120 [1000 KB] - Class I Transitional provisions under Article 120 of the MDR
PDF file Class I Transitional provisions under Article 120 of the MDR [899 KB] - Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
PDF file Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software [969 KB] - The European Medical Device Nomenclature (EMDN)
PDF file The European Medical Device Nomenclature (EMDN) [340 KB] - Clinical Evaluation – Equivalence
PDF file Clinical Evaluation – Equivalence [1.000 KB] - Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC
PDF file Guidance on Sufficient Clinical Evidence for Legacy Devices [861 KB] - Post-market clinical follow-up (PMCF) Plan Template
PDF file Guidance on PMCF Plan Template [705 KB] - Post-market clinical follow-up (PMCF) Evaluation Report Template
Guidance on PMCF Evaluation Report Template [681 KB] - Safety reporting in clinical investigations of medical devices under the MDR
PDF file Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 [261 KB] - Clinical evaluation assessment report template
PDF file Clinical evaluation assessment report template [262 KB] - Guidance for notified bodies on the use of MDSAP audit reports carried out under the MDR and IVDR
PDF file Guidance on MDSAP audit [89 KB] - Management of Legacy Devices under the MDR in EUDAMED
PDF file Management of Legacy Devices under the MDR [1 MB] - Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
PDF file of Guidance on harmonised administrative practices [610 KB] - Questions and Answers on Custom-Made Devices
PDF file Questions and Answers on Custom-Made Devices [311 KB] - Guidance on standardisation for medical devices
PDF file Guidance on standardisation for medical devices [656 KB] - Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
PDF file Regulation (EU) 2017/745 – Questions & Answers [424 KB] - Clinical investigation application/notification documents
PDF file Clinical investigation application/notification documents [201 KB] - Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
PDF file Position Paper on the Implementation of UDI requirements for contact lenses etc. [222 KB] - Guidance on Implant Card – Device types
PDF file Guidance on Implant Card – Device types [685 KB] - FAQ on the European Medical Device Nomenclature (EMDN)
PDF file FAQ on the European Medical Device Nomenclature (EMDN) [246 KB] - The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
PDF file The status of Appendixes E-I of IMDRF N48… [416 KB] - Guidance note integration of the UDI within an organisation’s quality
PDF file Guidance note integration of the UDI within an organisation’s quality [611 KB] - Guidance on Classification of Medical Devices
PDF file Guidance on Classification of Medical Devices [2 MB] - 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
PDF file Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’… [856 KB] - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
PDF file Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 [795 KB]
Download Section Guidance Documents IVDR
- Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
PDF file Factsheet for IVD Manufacturers [340 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 [164 KB] - UDI Core Elements
PDF file UDI Core Elements [287 KB] - UDI FAQs
PDF file Regulation Tool EU MDR IVDR [418] - 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] - Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
PDF file Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software [969] - The European Medical Device Nomenclature (EMDN)
PDF file The European Medical Device Nomenclature (EMDN) [340 KB] - Clinical Evidence Requirements for CE certification under the IVDR (issued by MedTech Europe)
PDF file Clinical Evidence Requirements for CE certification under the IVDR [2000 KB] - Guidance for notified bodies on the use of MDSAP audit reports carried out under the MDR and IVDR
PDF file Guidance on MDSAP audit [89 KB] - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the IVDR
PDF file on Classification Rules for in vitro Diagnostic Medical Devices under the IVDR - Management of Legacy Devices under the MDR in EUDAMED
PDF file Management of Legacy Devices under the MDR [1 MB] - Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
PDF file of Guidance on harmonised administrative practices [610 KB] - FAQ on the European Medical Device Nomenclature (EMDN)
PDF file FAQ on the European Medical Device Nomenclature (EMDN) [246 KB] - The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
PDF file The status of Appendixes E-I of IMDRF N48… [416 KB] - Guidance note integration of the UDI within an organisation’s quality
PDF file Guidance note integration of the UDI within an organisation’s quality [611 KB] - Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
PDF file Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices [586 KB] - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
PDF file Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 [795 KB]