CE marking is mandatory for certain product groups intended for sale within the European Union, the European Free Trade Association (EFTA), and Turkey. The manufacturers of products made within these countries, and the importers of goods made in other countries, affirm that CE-marked goods conform to EU standards.

At ISO, we develop International Standards, such as ISO 9001 and ISO 14001. ISO's Committee on Conformity Assessment (CASCO) has produced a number of standards related to the certification process, which are used by certification bodies.

Nov 18, 2022 · CE, ISO, and FDA certifications show that these devices meet all standards, from product design to manufacturing, packaging, and delivery. These certifications also reduce errors and improve product efficiency, increasing your credibility in the medical device industry.

The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.

Feb 13, 2023 · The CE mark is a mark that must be affixed on certain types of products by the manufacturer itself, which with it self-certifies compliance (or conformity) to the essential requirements for marketing and use in the European Union set out in …

Jun 3, 2024 · Product certifications from bodies like the FDA, CE, and ISO are essential pillars supporting the integrity and reliability of healthcare products worldwide. They provide a structured framework for manufacturers to follow, ensuring that only the safest and most effective products reach the market.

Jan 30, 2025 · 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?