Risk Class
The risk class determines the regulatory requirements that a medical device must meet and is established based on the classification rules set out in EU MDR Annex VIII. The EU MDR distinguishes four risk classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Classification is based on factors such as duration of use, degree of invasiveness, and the body part concerned. Higher risk classes require more comprehensive conformity assessment procedures involving a Notified Body.
The risk class determines the scope of regulatory scrutiny and thus indirectly also the requirements for quality assurance of IFU translations. Manufacturers of higher-class products should implement more robust translation processes.
Frequently Asked Questions
Does the risk class influence the requirements for IFU translation?+
The linguistic requirements for IFUs generally apply equally to all risk classes. However, as the risk class increases, so do the requirements for technical documentation and the involvement of a Notified Body, which indirectly also increases the depth of translation review. At higher risk classes, translations are more frequently checked during audits.