The IVDR assigns clear legal responsibilities to every company in the supply chain and introduces traceability and transparency through unique device identification and the EUDAMED database.
Who does what
| Role | Key obligations |
|---|---|
| Manufacturer | Full responsibility for compliance: QMS, technical documentation, conformity assessment, PMS, vigilance, registration and liability coverage |
| Authorized representative | Required for manufacturers outside the EU; verifies documentation, cooperates with authorities and is jointly liable for defective devices |
| Importer | Verifies that devices are CE marked and registered, adds its details to the device and keeps complaint and recall records |
| Distributor | Checks labeling and documentation, ensures proper storage and passes on complaints and safety information |
Person responsible for regulatory compliance
Manufacturers and authorized representatives must have a person responsible for regulatory compliance (PRRC) with documented expertise, either a relevant university degree plus at least one year of experience, or four years of experience in regulatory affairs or quality management. Micro and small enterprises may use an external PRRC who is permanently and continuously available.
Unique device identification
- Basic UDI-DI: the main identifier for a device model in EUDAMED and on certificates and declarations
- UDI-DI: identifies a specific device version or configuration
- UDI-PI: production identifiers such as lot, serial number and expiry date
- For software, the UDI is assigned at system level and changes with significant updates
EUDAMED
EUDAMED is the EU database for medical devices and IVDs. Four of its six modules became mandatory on May 28, 2026: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. New devices must be registered before they are placed on the market. Devices already on the market before that date that continue to be sold must be registered by November 28, 2026, and notified bodies have until May 28, 2027 to upload certificates issued before mandatory use. The vigilance and performance study modules will follow.
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.