Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
Draft EUDAMED Roadmap of Modules
Regulatory Updates – January 2022
Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world
EU MDR & IVDR Harmonized Standards Lists Updated – 9 Added to MDR & 5 to IVDR
The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
CEN & CENELEC Accepts ECs Standardization Request
In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not
Notified Bodies Can do Remote Audits for MDR & IVDR
Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote