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14 paź 2024 · CE Marking serves as a vital certification mark, indicating that a medical device meets the stringent health, safety, and environmental protection legislation set forth by the EU.
3 lip 2024 · CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. When is CE marking mandatory?
22 gru 2022 · CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards.
A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation and must be CE marked. Examples of medical devices with an ancillary medicinal substance include: drug-eluting stents; bone cement containing an antibiotic;
Contents. What is CE marking? Why is CE marking important? CE marking responsibilities. Manufacturer responsibilities for CE marking. Importer responsibilities for CE marking. Distributor responsibilities for CE marking. What countries require or accept CE marking? Which medical devices require a CE mark? Technical documentation.
Definition: CE marking is a certification mark that indicates a product’s compliance with essential health and safety requirements set forth by EU directives. It signifies that your product meets the necessary standards for market access.
25 kwi 2023 · In the case of medical devices, CE marking certifies that the medical device meets the General Safety and Performance Requirements (GSPRs). Only the lowest risk devices (Class I self-certified) are exempt from notified body conformity assessment to obtain CE marking. Classification.
