Our CEO Renaud is joined again by Clive Greenwood, a China-based product compliance expert, to discuss the new EU MDR.
We all heard about the Wild West of PPE imports in the early days of the pandemic where worrying amounts of substandard PPE was imported into countries desperate for supplies, even though they provided dubious protection against infection. As you’ll hear, the new MDR makes manufacturers and importers accountable for what they bring in and will allow authorities to find, enforce, and prosecute infractions more easily.
So, let’s get into how this new compliance standard for medical devices could affect you today and how it’s set to form a template for future standards.
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Here’s what’s included in the episode…
✅ What the Medical Device Regulation (EU) 2017/745 (MDR) is.
✅ If you import medical devices into the EU and have a CE certificate granted under the old MDD, when do you have to switch and will it be an easy transition?
✅ The Scope of the MDR
✅ Why customs will now more easily be able to check the medical devices are compliant
✅ What information about your QMS and processes should be included in the technical document pack
✅ Notified bodies now have to take more action to monitor ongoing production after certification.
✅ Who’s liable now if there is any trouble with the products?
✅ What happens if it’s found that a fake document was submitted or a problem was found?
✅ How can companies transition from the old MDD to the new MDR?
✅ What if you’re planning to bring a medical device to the market soon?
✅ Overall, why is the EU MDR beneficial?
…and much more!
We at Sofeast are not lawyers. What we discussed above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.
- Read the entire Medical Device Regulation (EU) 2017/745 (MDR)
- New EU MDR: Who Are The “Economic Operators” For Imported Devices?
- EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
- EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]
- Compliance testing consulting from Sofeast
- We’re Buying Medical Devices From China And Are Worried Our Supplier Isn’t Legit | Disputes With Chinese Suppliers Q&A (Volume 8)
- Do Sofeast’s quality inspectors confirm that the products are fully compliant based on certificates provided by the factory?
- 11 Common Electronic Product Certification And Compliance Requirements
- Why YOU Need a Product Safety Program
- Can Sofeast help us with the certification of our new product?
- What Is Compliance Testing? [Podcast]
- US Compliance Documents When Importing from China: Q&A With an Expert
- Product Compliance 101: What Every Importer Must Know [Q&A]
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