When making a custom-made device, what CE marking strategy is required?

The correct choice indicates that for custom-made devices, a CE mark is not required, but a Declaration of Conformity (DoC) is indeed needed. This reflects the specific regulations surrounding custom-made devices within the European market, which are designed for individual patients based on a medical prescription, hence the personalized nature of their production.

In this context, the CE marking process is generally reserved for devices that are intended to be mass-produced and sold in the market. Custom-made devices, however, are typically exempt from this requirement as they do not pose the same level of risk to the general public. Manufacturers of custom-made devices must provide a Declaration of Conformity to demonstrate compliance with relevant regulations. Additionally, Member States may ask for a list of these devices to keep track of their distribution and ensure patient safety.

This effective framework ensures that while these personalized devices are not subjected to the same rigorous marking process as widely sold medical devices, there is still a degree of oversight established through the requirement for a DoC.