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
Regulatory Updates – January 2022
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
FAQs on ISO 15223-1
We did a really popular webinar titled ATTENTION ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical Device Labeling to Comply with the New Requirements and from that webinar came a lot of questions. So, we
Consultation on the future regulation of medical devices in the United Kingdom
“The Medicines and Healthcare products Regulatory Agency (MHRA) is working to develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation….”
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.