Document Name Document Type Document Language Document Publication Date
Regulation 2017/745 of the European Parliament and of the Council (MDR) PDF TR 05/05/2017
Regulation (MDR) of the European Parliament and of the Council No 2017/745 Annexes PDF TR 05/05/2017
MDCG 2022-9 Summary of safety and performance Template PDF EN 05/2022
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR PDF EN 11/2019
MDCG 2021-24 Guidance on classification of medical devices PDF EN 11/2021
MDCG 2020-13 Clinical evaluation assessment report template PDF EN 07/2020
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies PDF EN 04/2020
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies PDF EN 04/2020
MDCG 2019-9 Rev.1Summary of safety and clinical performance A guide for manufacturers and notified bodies PDF EN 03/2022
IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices (N70) Final PDF EN 11/04/2023
Software as a Medical Device (SaMD): Key Definitions PDF EN 09/12/2013
Quality Management Systems - Process Validation Guidance PDF EN 02/01/2004
MDCG 2019-8 v2 Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices PDF EN 03/2020
MDCG 2021-11 Guidance on Implant Card – ‘Device types’ PDF EN 02.07.2023
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software PDF EN 02.07.2023
MDCG 2021-11 Guidance on Implant Card – ‘Device types’ PDF EN 02.07.2023

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