Asma Benidjer

12 Sep 2024 | The team

With over five years of experience as an internal auditor and inspector in the financial sector, I have honed my regulatory skills and developed a particular proficiency in analyzing complex data. As a Doctor of Pharmacy and holder of a Master of Science in...

EU/European Commission: Artificial Intelligence Questions and Answers Update – August 2024

19 Aug 2024 | All the News

EU/European Commission: Artificial Intelligence Questions and Answers Update – August 2024 EU/European Commission: Artificial Intelligence Questions and Answers Update- August 2024 If summer and rest bring answers to your existential questions, this August the...

AI Act – what impact will it have on devices incorporating artificial intelligence systems?

19 Jul 2024 | All the News, Artificial intelligence

AI Act – what impact will it have on devices incorporating artificial intelligence systems? Do you manufacture devices incorporating artificial intelligence systems and wonder how the newly published AI Act will impact you? Read the rest of this article 😉 The...

Summaries of MDCG documents

25 Jun 2024 | All the News, MDCG

This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...

MDCG 2024-10 – Clinical evaluation of orphan medical devices – June 2024

25 Jun 2024 | All the News, MDCG, MDCG

Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...

MDCG  2024-7 – Preliminary assessment review (PAR) form template (MDR) – May 2024.

23 May 2024 | MDCG, MDCG

Theme Assessment of notified bodies  Target Audience Designating authority, NB  Products concerned MD Documents mentioned MDR (EU) 2017/745 – article 39 MDCG 2022-13  This guidance document is a form template to be used by the designating authority as part of the...

MDCG  2024-9 – Preliminary re-assessment review template – IVDR (Regulation (EU) 2017/746)  – May 2024

23 May 2024 | MDCG, MDCG

Theme Re-assessment of notified bodies  Target Audience Designating authority, NB  Products concerned IVD Documents mentioned IVDR (EU) 2017/746 article 40(10) MDCG 2022-13  This document is a template form to be used by the designating authority in the context of the...

MDCG  2024-8 – Preliminary assessment review template – IVDR (Regulation (EU) 2017/746) – May 2024

23 May 2024 | MDCG, MDCG

Theme Assessment of notified bodies  Target Audience Designating authority, NB  Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 35 MDCG 2022-13  This guidance document is a form template to be used by the designating authority in the context of...

MDCG  2024-6 – Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745)  – May 2024

23 May 2024 | MDCG, MDCG

Theme Re-assessment of notified bodies  Target Audience Designating authority, NB  Products concerned MD Documents mentioned MDR (EU) 2017/745 article 46 MDCG 2022-13  This document provides a template form for use by designating Authorities (NAs) in the reassessment...

MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024

29 Apr 2024 | MDCG, MDCG

Theme Investigator’s brochure  Target Audience Sponsor of clinical investigations  Products concerned MD Documents mentioned MDR (EU) 2017/745 :   – article 70  – Annex XV Chapter II Section 2  ISO14155:2020  This guidance document is intended to assist sponsors of...