# EU MDR/IVDR Medical Device

Product Safety & Market Access Certifications

###### European Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746)

## EUDAMED Goes Mandatory May 2026. 80% of IVDs Just Got Up-Classified. Is Your Supply Chain Evidence Audit-Ready?

EU MDR/IVDR compliance requires end-to-end documentation from device classification through post-market surveillance—with supplier-level evidence across every component and material. EUDAMED registration becomes mandatory May 28, 2026. Notified Body certification reviews average 13–18 months. Legacy device transition deadlines are converging in 2027–2028, and Notified Body capacity remains constrained.

Certivo automates supplier evidence collection from material declaration to audit-ready technical documentation.

### Key Statistics
- **80%** Of IVDs up-classified under IVDR, now requiring Notified Body involvement
- **13–18 months** Average Notified Body certification review timeline
- **May 2026** EUDAMED mandatory registration deadline for new devices

## Regulation Overview

### Jurisdiction
European Union / European Economic Area (UK MHRA framework applies separately post-Brexit)

### Regulatory Body
European Commission; Competent Authorities per Member State; Notified Bodies for conformity assessment

### Regulation Number
- MDR: EU 2017/745; IVDR: EU 2017/746

### Effective Date
- MDR: May 26, 2021; IVDR: May 26, 2022 (transition deadlines extending through 2029)

### Official Source
[European Medical Device Regulations](https://health.ec.europa.eu/medical-devices-new-regulations_en)

### Key Threshold
Risk-based classification: MDR Classes I, IIa, IIb, III; IVDR Classes A, B, C, D

## What Is EU MDR/IVDR?

EU MDR/IVDR compliance is the EU's comprehensive regulatory framework for medical devices and in vitro diagnostics. These regulations replaced the former Medical Device Directives (MDD, AIMDD) and the In Vitro Diagnostic Directive (IVDD), introducing substantially stricter requirements for clinical evidence, post-market surveillance, quality management systems, and supply chain documentation.

Under the former IVDD, approximately 8% of IVDs required Notified Body involvement. Under IVDR, that figure rises to approximately 80%. Notified Body capacity remains constrained—only around 40 are designated under MDR, and fewer under IVDR. Average certification reviews run 13–18 months. EUDAMED registration becomes mandatory May 28, 2026, requiring actor registration, UDI/device data, and certificate uploads.

EU MDR/IVDR compliance requires substance-level data on materials in contact with patients—intersecting with chemical regulations like REACH and RoHS for restricted substances in device components. When device designs change or suppliers are substituted, the entire technical documentation package may require reassessment.

## Key Components / Sub-Frameworks

### Obligation
- Conformity assessment, CE marking, technical documentation, PMS

### MDR (EU 2017/745)
- Regulation for medical devices (Classes I, IIa, IIb, III)

### Obligation
- Conformity assessment, performance evaluation, CE marking

### IVDR (EU 2017/746)
- Regulation for in vitro diagnostic medical devices (Classes A, B, C, D)

### Obligation
- Mandatory registration of actors, devices (UDI), certificates, and vigilance reports

### EUDAMED
- European Database on Medical Devices

### Obligation
- Traceability from manufacturer through distribution to patient

### UDI System
- Unique Device Identification

### Obligation
- Complete device file; PMS plan, PSUR, vigilance reporting

### Annex II / III
- Technical Documentation and Post-Market Surveillance

### Obligation
- QMS foundation referenced throughout MDR/IVDR conformity assessment

### ISO 13485
- Quality Management System standard

## Key Compliance Requirements

### Who Must Comply
- Medical device and IVD manufacturers placing devices on the EU/EEA market
- Authorized representatives acting on behalf of non-EU manufacturers
- Importers placing medical devices or IVDs on the EU market
- Distributors handling devices within the EU supply chain
- Component and material suppliers providing evidence for device technical files
- Contract manufacturers and sterilization service providers

### Key Thresholds
#### Class IIa/IIb/III (MDR)
- Notified Body conformity assessment mandatory

#### Class A sterile/B/C/D (IVDR)
- Notified Body conformity assessment mandatory

#### May 28, 2026
- EUDAMED mandatory registration for new devices

#### December 31, 2027–2028
- MDR legacy device transition deadlines by device class

## Core Obligations
1. **Technical Documentation (Annex II)**
   - Complete device file: design, manufacturing, V&V, risk management, clinical/performance evaluation
   - **DEADLINE**: Before conformity assessment and market placement

2. **Conformity Assessment**
   - Notified Body review for all devices above Class I / Class A non-sterile
   - **DEADLINE**: Before CE marking and market placement

3. **EUDAMED Registration**
   - Actor registration, UDI/device registration, certificate upload
   - **DEADLINE**: New devices: May 28, 2026; Legacy devices: November 2026

4. **Post-Market Surveillance**
   - PMS plan, PSUR, periodic safety update reports, vigilance reporting
   - **DEADLINE**: Ongoing throughout device lifecycle

5. **Quality Management System**
   - ISO 13485-aligned QMS covering design, production, and post-market activities
   - **DEADLINE**: Maintained continuously; audited by Notified Body

## Frequently Asked Questions
### What companies and products are subject to EU MDR/IVDR compliance obligations?
Any company placing medical devices or in vitro diagnostic devices on the EU/EEA market must comply—including manufacturers, authorized representatives, importers, and distributors. MDR covers devices classified from Class I through Class III; IVDR covers IVDs from Class A through Class D. The regulation extends to component and material suppliers who must provide evidence supporting the manufacturer's technical documentation.