MedBoard & Easy Medical Device Regulatory Update Report

Medtech Regulatory Update - Monthly Podcast

April 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 Guidance · 2023-03-27 Extension of the MDR Transitional Period and Removal of the 'Sell Off' Periods
European Union / TEAM-NB Event · 2023-03-23 IVDR Technical Documentation Training for Manufacturers – 2nd session
European Union / EC Regulation (Draft) · 2023-03-22 Single Identifier for Similar Highly Individualised Devices
European Union / EC Regulation · 2023-03-20 Regulation (EU) 2023/607 - Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
European Union / EC Notice · 2023-03-20 SZUTEST Konformitätsbewertungsstelle GmbH, 38th Notified Body designated under MDR (EU) 2017/745
European Union / EC Notice · 2023-03-15 The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
European Union / TEAM-NB Notice · 2023-03-08 Frequency of complete re-assessments of notified bodies
United Kingdom (UK) / MHRA Notice · 2023-03-28 Extension of CE certificates
United Kingdom (UK) / MHRA Notice · 2023-03-15 MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products
United Kingdom (UK) / MHRA Notice · 2023-03-07 Advisory Group Reform Proposals: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform
United States of America (USA) / FDA Guidance · 2023-03-29 MDSAP AU P0002.008 - MDSAP Audit Approach
Brazil / ANVISA Notice · 2023-03-30 User gains platform for reporting adverse events
Switzerland / Swissmedic Notice · 2023-03-30 MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured
Switzerland / Swissmedic Notice · 2023-03-29 The Federal Council aims to safeguard the supply of medical devices
Switzerland / Swissmedic Notice · 2023-03-27 Swissmedic inspects Class I manufacturers in Switzerland
Ireland / HPRA Notice · 2023-03-22 Extension to MDR transitional provisions
Saudi Arabia / SFDA Guidance · 2023-03-22 MDS-G012 - Guidelines for essential and non-essential changes to requests for marketing permission for medical devices and supplies
Belgium / AFMPS Notice · 2023-03-23 New funding system for market surveillance of medical devices
Belgium / AFMPS Notice · 2023-03-20 Extension of the transition period for the European regulations on medical devices and in vitro diagnostics
Italy / Ministry of Health Notice · 2023-03-22 Medical devices, extension of the validity of certificates
Portugal / Infarmed Notice · 2023-03-21 Publication of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to the transitional provisions applicable to certain DMs and DIVs
Spain / AEMPS Notice · 2023-03-21 The Council of Ministers approves the new Royal Decree on Sanitary Products
Spain / AEMPS Notice · 2023-03-21 The AEMPS reports the publication of Regulation (EU) 2023/607, which modifies the Regulations for Medical Devices
Spain / AEMPS Regulation · 2023-03-21 Royal Decree 192/2023, of March 21, which regulates sanitary products.
Spain / AEMPS Notice · 2023-03-08 The AEMPS informs about the favorable vote of the Council of the EU to the proposal of modification of the Regulations of Sanitary Products
Bahrain / NHRA Guidance · 2023-03-27 Medical Devices Registration Guideline Version 8.0