Class I
Short definition
Class I is the lowest-risk class of medical devices under Regulation (EU) 2017/745, in which the manufacturer can declare conformity without the involvement of a notified body.
In plain language
The manufacturer is still required to meet the general safety and performance requirements and to have technical documentation, clinical evaluation, risk management and post-market surveillance. The exceptions are Class I devices that are sterile, have a measuring function or are reusable surgical instruments, for which a notified body verifies those specific aspects. Being Class I concerns the level of risk, not an absence of rules.
In practice, in an RVer session
The RVer base product is a Class I medical device registered with Infarmed (CDM no. 94571546), with a self-declared CE marking and no notified body.