If you intend to place a device on the market in an EU or EFTA country, it must be CE marked by you as a manufacturer or part of a registered clinical investigation. CE stands for “Conformité Européenne”. The CE mark means that the product meets the essential requirements of applicable directives.
Who is the manufacturer?
The manufacturer is defined as “The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.”
If one uses a contract manufacturer, it is a common misconception that the contract manufacturer is the “manufacturer” who CE marks the product, but this is not usually the case. The contract manufacturer carries out production on commission from the manufacturer, which means that in this case the client still has manufacturer responsibility and must CE mark the product. From an American perspective, the client is always the “manufacturer”, but the contract manufacturer may also have a greater responsibility and must, in most cases, have what is known as “establishment registration”.
But if I just lend the device to a doctor?
The first time a product is available for use or distribution, it is placed on the market. It is not relevant whether you charge anything for the product (for some companies, it is tempting to think that release to market is not done until you sell the product, and thus it is possible to postpone the CE marking, but this is not the case).
How do you do it?
There are several ways to CE mark a product and the method is, simply put, dependent on the type of product and how harmful it may be. In its simplest form, it involves:
- A clinical evaluation
- A technical file
- A quality management system
- Registration with the national competent authority
- A Declaration of Conformity
For products associated with the highest levels of risk, a full quality management system is required and the clinical evaluation, quality management system, and technical file must be reviewed by a third party.