MedBoard & Easy Medical Device Regulatory Update Report

Regulatory Update Monthly Podcast

January 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 Notice · 2022-12-23 QMD Services GmbH (NB 2962), 8th Notified Body designated under IVDR (EU) 2017/746
European Union / TEAM-NB Guidance · 2022-12-19 Team-NB Position Paper - The designation of notified bodies under the upcoming Artificial Intelligence Act
European Union / EC Guidance · 2022-12-16 Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
European Union / EC Guidance · 2022-12-16 MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
European Union / EC Guidance · 2022-12-14 MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746
European Union / EC Guidance · 2022-12-13 MDCG 2022-19 - Performance study application/notification documents under Regulation (EU) 2017/746
European Union / EC Report · 2022-12-13 Implementation Rolling Plan: Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - Latest update: November 2022
European Union / EC Meeting · 2022-12-12 MDCG EUDAMED working group meeting (15 December 2022)
European Union / EC Notice · 2022-12-09 Implementation of the Medical Device Regulation (MDR): EU MDR Transition Period extension proposal by the European Commission.
European Union / EC Guidance · 2022-12-09 MDCG 2022-18 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
European Union / EC Notice · 2022-12-08 Implementation of the Medical Device Regulation - Information from the Commission
European Union / European Council Notice · 2022-12-08 Provisional Agenda 9th Meeting - Implementation of the Medical Device Regulation (MDR)
European Union / EC Notice · 2022-12-08 ICIM S.P.A., 36th Notified Body designated under MDR (EU) 2017/745
European Union / EC Guidance · 2022-12-06 MDCG 2022-17 - MDCG position paper on ‘hybrid audits’ - December 2022
United Kingdom (UK) / MHRA Notice · 2022-12-20 Medical devices: UK approved bodies: The UL Internationa UK Ltd Scope document has been updated.
United Kingdom (UK) / MHRA Report · 2022-12-19 Using artificial intelligence (AI) to help radiologists with CT scans
United States of America (USA) / FDA Guidance (Draft) · 2022-12-15 Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022): Draft Guidance for Industry
United States of America (USA) / FDA Notice · 2022-12-07 Non-Invasive Body Contouring Technologies
United States of America (USA) / FDA Notice · 2022-12-07 Augmented Reality and Virtual Reality in Medical Devices
Switzerland / Swissmedic Notice · 2022-12-28 Frequently Asked Questions on medical devices - FAQ MD: Update of the section "Products without medical purpose"
Saudi Arabia / SFDA Guidance · 2022-12-14 MDS - G008 - Guidelines for classification of medical devices and supplies
Finland / FIMEA Notice · 2022-12-29 EU-level solutions proposed to challenges of availability of medical devices