Regulatory & Safety Experts for Global Medical Device Approvals
2 February 2022 On 1 February 2022 the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark
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
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
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
“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….”
