Attention! 1 year before UKCA is the law for Medical Devices in the UK
This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what Adam Rae will tell you.
We will mention the rules for UKCA, the documentation needed for the Approved Body situation, and also the Northern Ireland Situation.
So no need to read all the regulations, we will summarize the situation here and you will need to act immediately after that.
Who is Adam Rae?
Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who Is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links
- LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/
- Website: theotherconsultants.com
- Substack newsletter: https://theotherconsultants.substack.com/
- Download cheat sheet: https://mailchi.mp/easymedicaldevice/podcast-episode-186-ukca
4 Replies to “Attention! 1 year before UKCA is the law for Medical Devices in the UK”
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Hi Monir!
Very good topic! thanks for sharing it.
I just have one question, where in the UK MDR can we see the UKCA marking (design) dimensions like we have for CE marking on Annex 2?
Hi Catarina, the UK MDR is on their website. Check UK MDR 2002 and take last update. For the dimensions, I saw that on the UK Gov website but cannot remember if I have bookmarked the link.