MedBoard & Easy Medical Device Regulatory Update Report

Regulatory Update Monthly Podcast

December 2022 Podcast Episode

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

Podcast Footnotes by MedBoard:

European Union / EC Regulation · 2022-12-01 Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
European Union / EC Regulation · 2022-12-01 Commission Implementing Regulation (EU) 2022/2347 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
European Union / EC Guidance · 2022-11-30 Updated information pack for candidate EU reference laboratories published
European Union / EC Notice · 2022-11-29 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s., 35th Notified Body designated under MDR (EU) 2017/745
European Union / CAMD Notice · 2022-11-24 51th CAMD Meeting Statement
European Union / EC Meeting · 2022-11-15 MDCG - Market Surveillance working group meeting (23 November 2022)
European Union / EC Guidance · 2022-11-01 MDCG 2022-16: Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
United Kingdom (UK) / MHRA Guidance · 2022-11-16 Borderline products: how to tell if your product is a medical device: New section added 'Risk classification of medical devices'
United Kingdom (UK) / MHRA Notice · 2022-11-15 Using the UKCA marking: The deadline for when businesses need to use the UKCA mark has been extended
United States of America (USA) / FDA Form · 2022-11-30 EUA Template for Developers of Antigen Diagnostic Tests
United States of America (USA) / FDA Guidance · 2022-11-21 MDSAP AU P0027.007 - Post-Audit Activities and Timeline Policy
United States of America (USA) / FDA Report · 2022-11-01 MedSun Newsletter - November 2022
Australia / TGA Notice · 2022-11-03 Post-market review of spinal cord stimulation (SCS) devices
Canada / HC Guidance · 2022-11-15 Guidance on clinical evidence requirements for medical devices
Canada / HC Standards · 2022-11-15 List of recognized standards for medical devices
Canada / HC Notice · 2022-11-09 November 8, 2022 updates to list of medical devices for mandatory shortage and discontinuation reporting
Canada / HC Notice · 2022-11-01 Medical devices contained in electronic health record (EHR) products: Notice to industry
Switzerland / Swissmedic Notice · 2022-11-10 More than 700 participants at the information event on the new in vitro diagnostic medical devices regulation
China / NMPA Guidance · 2022-11-18 List of Mandatory Standards Applicable to Medical Device Products (No. 42 of 2022)
Malaysia / MDA Guidance · 2022-11-21 MDA/GD/0020: Change Notification for Registered Medical Device 4th Edition
Malaysia / MDA Guidance · 2022-11-21 MDA/GD/0026: Requirements for Labelling of Medical Devices 6th Edition
Bahrain / NHRA Notice · 2022-11-24 Circular No. (35) 2022: To All Medical Devices Importers and Suppliers - Reminder Regarding Deadline for Medical Devices and Supplies Authorized Representatives Registration
Finland / FIMEA Notice · 2022-11-24 Power blackouts do not require special preparedness measures from the users of medicines and medical devices