Date : 15/12/2016 (Final adoption by the CHMP) – June 14, 2017 (Effective date)
Author : ICH
Goal/scope : Internationally recognized recommendations for good clinical practices in biomedical research.
https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline
We are at your disposal to assist you in understanding and implementing these recommendations – do not hesitate to contact us: contact@ceiso.fr
Date : 2021
Author : MDCG
Goal/scope : Guidance on classification of medical devices.
Date : 2020
Author : MDCG
Goal/scope : Guidance on clinical evaluation – Equivalence.
Date : 2020
Author : MDCG
Goal/scope : Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software.
Date : 2022
Author : MDCG
Goal/scope : Guidance on Authorized Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
Date : 2022
Author : MDCG
Goal/scope : Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745.
All MDCG guides are available at the following address:
This page provides a series of documents to help stakeholders apply Regulation (EU) 2017/745 on medical devices (MDR). Most of the documents on this page are approved by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are written in collaboration with interested parties represented in the various groups and named according to the following format: “MDCG Year-Number-revision”.
We are available to assist you in understanding and applying these recommendations – do not hesitate to contact us: contact@ceiso.fr.
Date : 2020
Author : IMDRF
Goal/scope :
Terminologies for categorized Adverse Event Reporting (AER): terms, terminology and codes
This document is available at the following address:
We are at your disposal to help you understand and apply these recommendations – do not hesitate to contact us: contact@ceiso.fr
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