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Tag Archives: importing into the eu
What is the EU Ecodesign for Sustainable Products Regulation?
The European Union is getting serious about sustainability and is already working towards ‘becoming a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use.’ … Continue reading
The EU Ecodesign Regulation Is Coming, But Are You Prepared? [Podcast part1]
Sofeast CEO Renaud is joined again by friend of the show and product compliance expert, Clive Greenwood of SMC GLOBAL Manufacturing Consultants, to talk about the new ‘Ecodesign for sustainable products regulation’ set to become law in 2023 that will … 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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