MedBoard & Easy Medical Device Regulatory Update Report

Medtech Regulatory Update - Monthly Podcast

March 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 / TEAM-NB Event · 2023-03-02 New Team-NB initiative: IVDR Technical Documentation Training for Manufacturers
European Union / TEAM-NB Guidance · 2023-03-01 Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation
European Union / EMA Notice · 2023-02-27 EMA pilots scientific advice for certain high-risk medical devices
European Union / EC Notice · 2023-02-18 National Standards Authority of Ireland (NSAI), 10th Notified Body designated under IVDR (EU) 2017/746
European Union / EC Notice · 2023-02-16 MDC MEDICAL DEVICE CERTIFICATION GMBH, 9th Notified Body designated under IVDR (EU) 2017/746
European Union / EC Guidance · 2023-02-14 MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
European Union / EC Event · 2023-02-07 Day 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
European Union / EC Event · 2023-02-07 Day 2: 28 March 2023 IMDRF Stakeholder Forum
United Kingdom (UK) / MHRA Notice · 2023-02-20 Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
United States of America (USA) / FDA Report · 2023-02-14 List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
United States of America (USA) / FDA Report · 2023-02-03 MedSun Newsletter, February 2023
Brazil / ANVISA Guidance · 2023-02-27 Medical Device Clinical Evidence Guide - Concepts and Definitions
Brazil / ANVISA Guidance · 2023-02-27 Medical Device Clinical Evaluation Guide
Brazil / ANVISA Guidance · 2023-02-27 Medical device Clinical Investigation Guide
Switzerland / Swissmedic Guidance · 2023-02-17 BW630_30_010e_MB FAQ on in vitro diagnostic medical device notifications
Germany / BfArM Notice · 2023-02-08 Companion diagnostics (CDx)
Global Harmonization Working Party / GHWP Guidance · 2023-02-27 GHWP/WG2-WG1-WG3/F001:2023 - Categorisation of Changes to a Registered Medical Device
Global Harmonization Working Party / GHWP Media · 2023-02-23 Annex 6 - IMDRF Status Updates
Global Harmonization Working Party / GHWP Media · 2023-02-23 Annex 16 - European Union Updates
Global Harmonization Working Party / GHWP Guidance (Draft) · 2023-02-07 GHWP/WG2-WG1-WG3/P001:2023 - Categorisation of Changes to a Registered Medical Device (Proposed Document)
Ireland / HPRA Form · 2023-02-10 Article 97 Request Form - Request by a Manufacturer / Authorised Representative in accordance with MDCG-2022-18
Saudi Arabia / SFDA Event · 2023-02-27 Saudi Unique Device Identification (SAUDI-DI) for Medical Devices Requirements & Submission process
Saudi Arabia / SFDA Event · 2023-02-27 The Requirements for Clinical Evaluation Report of Medical Devices
Saudi Arabia / SFDA Form · 2023-02-16 Agreement between a single legal manufacturer and an authorized representative
Saudi Arabia / SFDA Form · 2023-02-16 Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative
Italy / Ministry of Health Notice · 2023-02-02 Breast implants, the mandatory national register is underway
South Africa / SAHPRA Guidance · 2023-03-01 Guideline on Questions and Answers Licensing of Medical Device Establishments
South Africa / SAHPRA Notice · 2023-02-08 Importing And Operating Unlicensed Dental X-Ray Equipment
Spain / AEMPS Notice · 2023-02-16 The AEMPS publishes a notice addressed to notified bodies and manufacturers of nasal sprays with virucidal or microbicidal action