EU MDR & IVDR: Regulasi Barcode Alat Kesehatan Eropa
European Union Medical Device Regulation and In Vitro Diagnostic Regulation barcode requirements — UDI-DI, EUDAMED, and compliance timelines.
EU MDR & IVDR: European Medical Device Barcode Regulations
The European Union's Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746) establish comprehensive barcode requirements for medical devices sold in the EU market, including a UDI system similar to but distinct from the US FDA's approach.
EU UDI System
The EU UDI system requires:
- UDI-DI (Device Identifier): Assigned by a GS1, HIBCC, or ICCBBA
- UDI-PI (Production Identifier): Lot, serial, expiry, manufacturing date
- EUDAMED registration: Devices registered in the European Database on Medical Devices
- Label marking: UDI barcode on every device label
- Direct marking: UDI on the device itself for reusable devices
EUDAMED Database
EUDAMED is the EU's central database for medical device information:
- UDI/Device registration: Manufacturers register DI and device attributes
- Certificates: Notified Body certificates linked to devices
- Vigilance: Incident reporting and field safety corrective actions
- Market surveillance: Regulatory authority access for oversight
All UDI-DI codes must be registered in EUDAMED before products can be placed on the EU market.
Compliance Timeline
| Device Class | MDR UDI Label | Direct Marking | EUDAMED |
|---|---|---|---|
| Class III (implantable) | Required | Required | Required |
| Class IIb | Required | Required | Required |
| Class IIa | Required | Required | Required |
| Class I | Required | Case-by-case | Required |
Barcode Requirements
The EU accepts barcodes from three issuing agencies:
| Agency | Standard | Barcode Format |
|---|---|---|
| GS1 | GS1 system | GS1 DataMatrix, GS1-128 |
| HIBCC | HIBC standard | Code 128, Data Matrix |
| ICCBBA | ISBT 128 | Code 128 |
Data Matrix with GS1 AIs for pharma and food traceability." data-category="2D & Matrix Symbologies">GS1 DataMatrix is the most widely adopted format due to its compact size and support for all required data elements.
Differences from FDA UDI
| Feature | EU MDR | FDA UDI |
|---|---|---|
| Database | EUDAMED | GUDID |
| Issuing agencies | GS1, HIBCC, ICCBBA | Same |
| Direct marking | Required for reusable Class I+ | Required for Class III implants |
| Basic UDI-DI | Required (groups device models) | Not required |
| Certificates | Linked in EUDAMED | Not linked |
The Basic UDI-DI
Unique to the EU system, the Basic UDI-DI is a higher-level identifier that groups related device models. It is registered in EUDAMED but does not appear on labels or barcodes. It enables regulatory oversight at the device family level.
Implementation for Manufacturers
- Obtain a GS1 Company Prefix (if not already registered)
- Assign UDI-DI (GTIN) to each device version and configuration
- Define Basic UDI-DI groupings
- Register in EUDAMED
- Design compliant labels with barcode, human-readable UDI, and CE marking
- Implement production systems for PI encoding (lot, serial, dates)
- Verify barcode quality against ISO/IEC 15415" data-definition="International standard for 2D barcode print quality grading." data-category="Printing & Quality">ISO/IEC 15415