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What Are Harmonized Standards Under EU MDR And EU IVDR?

In this video I’ll be focusing on providing a clear picture on: 1. What is the definition of a harmonized standard; 2. What is the process for harmonizing a standard; 3. Whether using harmonized standards is a requirement; and 4. I’ll provide links to where you can find a list of harmonized standards. All this and more to help you be prepared for an important part of the CE conformity assessment process! Here are links to harmonized standards lists (see bottom of linked page): Medical Device (EU MDR): https://single-market-economy.ec.euro... In Vitro Diagnostic Device (EU IVDR): https://single-market-economy.ec.euro... I hope you find this information helpful as a part of your EU MDR compliance strategy. If you need further advice, please contact me through the email below. Email Contact: [email protected] Website Contact: https://qrspecialists.com/contact-us/ I've also written a blog post on this subject if you prefer to read it... Blog Post: https://qrspecialists.com/harmonized-... Chapter Time Markers: 0:00 Intro 1:06 What is the definition of a harmonized standard? 2:25 What is the process for harmonizing a standard? 3:02 Is conformance to harmonized standards required? 3:47 Important Tip: Maintain copies of harmonized versions of standards 4:21 Where do you find a list of harmonized standards?