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Tag Archives: eu mdr
Latest Asia Manufacturing Trends and Upcoming Regulations Overview (Dec ’22)
On December 13th 2022, our CEO Renaud joined Global Sources‘ Tom McGrenery for a fireside chat about some of the broad Asian manufacturing trends we’ve seen recently, as well as the new regulatory frameworks for manufacturing, new technologies or services. … Continue reading
EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]
If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. But what is the path to get it certified? … Continue reading
Posted in EU MDR
Tagged medical device classes, ce mark, importing into the eu, eu mdr, medical devices, medical supplies
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New EU MDR: Who Are The “Economic Operators” For Imported Devices?
Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved … Continue reading
Posted in EU MDR
Tagged importing into the eu, eu mdr, medical devices, compliance, product compliance, importing from china, ppe
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EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that. As we discussed recently, the companies involved in … Continue reading
Posted in EU MDR
Tagged medical device classes, ce mark, importing into the eu, eu mdr, medical devices, product compliance, product safety
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How The EU MDR Will Change The Medical Device Industry Forever [Podcast]
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 … Continue reading
Posted in EU MDR, Sofeast Podcast
Tagged eu mdr, medical devices, compliance, product compliance, product safety, sourcing ppe, importing from china, ppe
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