MedBoard & Easy Medical Device Regulatory Update Report

Medtech Regulatory Update - Monthly Podcast

July 2023 Podcast Episode

Easy Medical Device and MedBoard collaborate to bring you the Top MedTech Regulatory News of the Month.

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Podcast Footnotes by MedBoard:

European Union / EC Regulation · 2023-06-20 Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance)
European Union / EC Notice · 2023-06-07 Cybersecurity and privacy in AI - Medical imaging diagnosis
United Kingdom (UK) / MHRA Notice · 2023-06-20 Borderline products: how to tell if your product is a medicine
United Kingdom (UK) / MHRA Regulation · 2023-06-16 Implementation of the Future Regulations
United Kingdom (UK) / MHRA Notice · 2023-06-14 Software and AI as a Medical Device Change Programme - Roadmap
United Kingdom (UK) / MHRA Regulation · 2023-06-09 The Medical Devices (Amendment) (Great Britain) Regulations 2023
United States of America (USA) / FDA Guidance · 2023-06-14 Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
United States of America (USA) / FDA Event · 2023-06-13 Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions
Australia / TGA Guidance · 2023-06-30 Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)- Version 1.9, June 2023
Australia / TGA Notice · 2023-06-28 The TGA's approach to delays in medical device conformity assessment recertification
Switzerland / Swissmedic Guidance · 2023-06-21 Medicinal products with a medical device component (combination products)
Malaysia / MDA Notice · 2023-06-27 Announcement: MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device
Saudi Arabia / SFDA Event · 2023-06-26 Artificial Intelligence and Software Based on Medical Device
Saudi Arabia / SFDA Event · 2023-06-26 Introducing the Rules for Classifying the Risk of Medical Devices
France / ANSM Notice · 2023-06-13 ANSM asks medical device manufacturers who send out safety notices to include the barcode of the devices concerned.
Spain / AEMPS Regulation · 2023-06-19 The AEMPS provides information on the procedure to be followed in clinical trials involving drugs and medical devices.

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