Class I MDR
EU REP Support for Class I Medical Device Manufacturers
Focused support for manufacturers of Class I devices established outside the European Union.
Class I still carries MDR obligations
Class I devices are lower-risk devices, but manufacturers still need appropriate classification, documentation, labelling, registration and post-market processes.
EU REP requirement
Manufacturers established outside the EU still require an appropriate EU Authorised Representative for covered devices placed on the Union market.
Class I categories
- General Class I devices.
- Class Is — sterile devices.
- Class Im — devices with a measuring function.
- Class Ir — reusable surgical instruments.