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
FDA Recognizes IEC 60601-1 Edition 3.2
On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List
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
IEC 60601 Amendments Presentation Now on MDG Premium
Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.
Happy MDR + Day 1 Past DoA
DATELINE 27 MAY 2021: Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.
What does that all mean?
The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.