MDR and IVDR Regulations: Implications for Device Registration

The transition from directives to regulations represents a fundamental paradigm shift. The former directives (93/42/EEC for medical devices, 90/385/EEC for active implantable devices, and 98/79/EC for in vitro diagnostics) left room for interpretation when transposed into national law by Member States. The new MDR and IVDR regulations are directly applicable across all 27 EU Member States without national transposition, ensuring complete harmonization. This change strengthens patient safety, improves market transparency, facilitates device traceability, and standardizes practices throughout the European Union.

MDR introduces several mandatory registration requirements that manufacturers must fulfill. All economic operators including manufacturers, authorized representatives, and importers must register in EUDAMED and obtain a Single Registration Number (SRN). Complete device registration is now required for all devices, including Class I devices, in EUDAMED’s UDI database before market placement. Each device must receive a Unique Device Identifier (UDI) composed of a UDI-DI (device identifier) and UDI-PI (production identifier). Additionally, the new Basic UDI-DI identifier groups device families sharing the same intended purpose and essential characteristics.

IVDR introduces a risk-based classification system similar to MDR but with specificities for in vitro diagnostic devices. The regulation establishes a new classification into four risk classes (A, B, C, D) replacing the old list-based system, with approximately 80% of IVDs being reclassified to higher risk classes. IVDR includes specific requirements for companion diagnostics that guide therapeutic decisions and enhanced surveillance for high-risk tests (Class D). This new classification directly affects conformity assessment procedures and the information that must be recorded in EUDAMED.

The Master UDI-DI is a new concept introduced through delegated regulations for highly individualized medical devices such as contact lenses, spectacle frames, and corrective lenses. This identifier allows manufacturers to avoid registering each individual device under a separate UDI-DI. Instead, devices sharing the same clinically relevant parameters can be grouped under a single Master UDI-DI, streamlining registration in EUDAMED while enhancing traceability in accordance with Regulation (EU) 2017/745. This approach significantly reduces administrative burden for manufacturers of customized devices.

The registration timeline depends on when devices are placed on the market, assuming publication in the Official Journal of the EU on September 1, 2025. For devices under MDR placed on the market from March 1, 2026, immediate mandatory registration is required before market placement. Devices placed on the market before March 1, 2026, must be registered by September 1, 2026. Similar periods apply for IVDR devices, but the overall timeline is extended due to the later application date. It’s crucial to distinguish between the transition period (how long devices may continue being marketed under former directives) and the registration period (when device data must be recorded in EUDAMED).

The UDI-DI (UDI Device Identifier) uniquely identifies each individual medical device and must appear on product labeling. The Basic UDI-DI serves as a grouping identifier for families of devices that share the same intended purpose and essential characteristics. While the UDI-DI appears on packaging and labeling, the Basic UDI-DI never appears on product labeling but is used in regulatory documentation such as certificates, declarations of conformity, and serves as a primary key in EUDAMED for linking related information across modules.

Legacy devices are medical devices that were compliant under the former directives and benefit from transition periods under MDR/IVDR. These devices must still be registered in EUDAMED according to the same timelines as new devices, unless the same device is already registered under MDR/IVDR or is no longer being marketed. For legacy devices, manufacturers can use the existing identifier with a “B-” prefix to create the Basic UDI-DI, or generate a new EUDAMED-DI. There is a one-to-one relationship between the UDI-DI and Basic UDI-DI for legacy devices.

Manufacturers must undertake comprehensive data preparation including identifying all devices subject to registration and gathering all required information for each device according to the EUDAMED data model. This involves structuring information properly and verifying data quality and consistency before submission. The data must include device characteristics, manufacturer information, intended use, classification, and all regulatory documentation. Data integrity following ALCOA+ principles becomes crucial, requiring robust validation processes and clear governance structures.

Manufacturers’ information systems require significant evolution to manage new identifiers including UDI-DI and Basic UDI-DI, maintain consistency between regulatory and commercial data, and facilitate updates and modifications of registered data. Systems must ensure traceability of all changes and support the complex data relationships required by EUDAMED. Integration capabilities with EUDAMED’s APIs become essential for larger manufacturers, while smaller companies may rely on manual entry or file-based submissions.

Robust governance of regulatory data becomes essential under MDR/IVDR, requiring clearly defined responsibilities across the organization and established data validation and approval processes. Effective change management procedures must be implemented along with an archiving strategy compliant with regulatory requirements. Cross-functional collaboration between regulatory affairs, quality, IT, and commercial teams becomes critical. Staff training on new requirements and ongoing monitoring of regulatory changes are fundamental to maintaining compliance.