MedBoard & Easy Medical Device Regulatory Update Report

Regulatory Update Podcast

October 2022 Podcast Episode

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

Podcast Footnotes:

European Union / TEAM-NB Guidance · 2022-10-07 Team-NB/ NBCG Med Position Paper - Class D measures in the absence of EU Reference Laboratories- Points to consider for Notified Body approach
United Kingdom (UK) / MHRA Guidance · 2022-10-07 Medical devices: guidance for manufacturers on vigilance - Detailing changes to the Incident reporting system in the section 'Changes to the Incident reporting system'
European Union / TEAM-NB Form · 2022-10-06 Team-NB Position Paper: Transfer Agreement specifying the terms of voluntary change of notified body under Regulation(EU)2017/745 or Regulation(EU)2017/746
European Union / TEAM-NB Guidance · 2022-10-06 Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
Switzerland / Swissmedic Guidance · 2022-10-03 Swissmedic checked the Swiss authorized representatives (CH-REP)
United Kingdom (UK) / MHRA Notice · 2022-09-29 MHRA appoints first new UK Approved Body to certify medical devices since Brexit
European Union / TEAM-NB Report · 2022-09-28 Notified Body position paper on transitional period for implementation of MDCG guidances and best practice documents
Finland / FIMEA Notice · 2022-09-28 Medical device distributors not required to submit device notifications in 2022
European Union / TEAM-NB Report · 2022-09-27 Notified bodies paper on the application of hybrid audits to quality management system assessments under MDR/IVDR
European Union / EC Notice · 2022-09-26 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., 33rd Notified Body designated under MDR (EU) 2017/745
United Kingdom (UK) / MHRA Guidance · 2022-09-22 Notify the MHRA about a clinical investigation for a medical device - Added section 'Quarterly Summary Reports'
European Union / EC Guidance · 2022-09-14 MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
International Medical Device Regulators Forum / IMDRF Report · 2022-09-09 Meeting no 22 - Update on EU regulatory developments
International Medical Device Regulators Forum / IMDRF Report · 2022-09-09 Meeting no 22 - Regulatory Update Swissmedic
Switzerland / Swissmedic Event · 2022-09-05 New regulations on in vitro diagnostic medical devices
European Union / EC Guidance · 2022-09-08 Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
United Kingdom (UK) / MHRA Guidance · 2022-09-06 Medical devices: software applications (apps) - Appendices 1, 2 and 3 have been added to the attachments: Appendix 1 Symptom checkers; Appendix 2 Clinical calculators; Appendix 3 ‘drives or influences the use of a device’
United States of America (USA) / FDA Guidance · 2022-10-06 Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff
United States of America (USA) / FDA Guidance · 2022-09-22 Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff
Japan / PMDA Notice · 2022-10-04 Labeling of Codes on Containers to Identify Medical Devices, In Vitro Diagnostics
Singapore / HSA Guidance · 2022-09-23 GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices Revision 3
Brazil / ANVISA Notice · 2022-09-14 Anvisa updates rules for the regularization of medical devices in Brazil
Saudi Arabia / SFDA Event · 2022-09-14 Requirements of Clinical Evaluation and Post Market Clinical Follow-up

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