What are the implications of modifying a CE marked product?

Let us guide you through the principles of CE marking step by step. We explain many of the words used in the context of CE marking, and you can get answers to ... The checklist for CE marking shows which steps you need to take to get a CE marking for your product. CE marking does not mean that a product was made in the EEA , but shows that the product meets all the relevant EU requirements and has been assessed as such ... GUILFORD, CT – February 21, 2023 — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's ... Directive 2014/68/EU defines the safety requirements for pressure equipment throughout the EU and the European Economic Area. CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE marking indicates that an IVD device complies with the European In-Vitro ... 10 steps to success: 1. Determine intended purpose 2. Determine classification 3. Determine conformity assessment routes 4. Comply with conformity requirements. Sep 1, 2023 ... CE Mark Directives for Wireless Devices. For wireless devices, it's crucial to adhere to specific directives that regulate their functionality ... Jul 25, 2022 ... The ubiquitous emblem of the CE mark effectively determines which goods in key product categories can be legally sold within the European Economic Area. The CE marking shall be affixed before the product with digital elements is placed on the market. It may be followed by a pictogram or any other mark indicating ...