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Tag Archives: ce mark
How to Comply with CE and UKCA? [Podcast]
Renaud and Adrian discuss CE and UKCA compliance. These are EU and British regulations for product safety, health, and environmental requirements. If you sell products in these markets you’ll need to add the CE or UKCA mark to them, so … Continue reading
Posted in Sofeast Podcast
Tagged ukca mark, eu regulations, ce mark, product compliance
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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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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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