Scope

The MDR covers all medical devices placed on the EU market, including accessories, devices made from substances absorbed or dispersed in the body, and certain aesthetic products. It applies to manufacturers, authorised representatives, importers, and distributors.

Key obligations

• Establish and maintain a Quality Management System (QMS)
• Prepare technical documentation per Annex II and III
• Implement a post-market surveillance system
• Report serious incidents and field safety corrective actions
• Assign a Person Responsible for Regulatory Compliance (PRRC)
• Register with EUDAMED and assign UDIs

Device classification

MDR Annex VIII defines 22 classification rules organized by device type: non-invasive (Rules 1–4), invasive (Rules 5–8), active (Rules 9–13), and special rules (Rules 14–22). Devices are classified into four risk classes:

When multiple rules apply, the strictest classification prevails. Try the interactive classification wizard →

Conformity assessment

The route to CE marking depends on the device class:

• Class I: Self-declaration (Annex IV) — no notified body involvement, except for sterile, measuring, or reusable surgical instruments
• Class IIa: Quality system (Annex IX Ch. I + III) or product verification (Annex XI Part A)
• Class IIb: Full quality assurance (Annex IX) or type examination + production verification (Annex X + XI)
• Class III: Full quality assurance (Annex IX Ch. I + II) with design dossier review

Technical documentation

Annex II requires a comprehensive technical file including: device description and specification, intended purpose, design and manufacturing information, GSPR checklist, benefit-risk analysis, clinical evaluation, product verification and validation. Annex III defines post-market surveillance documentation requirements.

Explore the 87-template documentation library →

Transition timeline

• 26 May 2021: MDR date of application
• 26 May 2024: Extended transition for Class III and implantable devices
• 31 Dec 2027: Final deadline for other legacy devices under transitional provisions (Article 120)
• 26 May 2028: All devices must comply with MDR — no more sell-off of MDD-certified devices

Scope

The IVDR covers all in vitro diagnostic medical devices — reagents, instruments, software, specimen receptacles, and accessories used for examination of specimens derived from the human body. This includes companion diagnostics, self-testing devices, and near-patient testing devices.

Key changes from IVDD

• New risk-based classification system (Classes A–D) replacing the list-based approach
• Notified body involvement required for Classes B, C, and D (was only ~10% under IVDD)
• Performance evaluation requirements significantly strengthened
• Post-market performance follow-up (PMPF) required
• EUDAMED registration and UDI assignment mandatory
• EU Reference Laboratories for Class D devices

Device classification

IVDR Annex VIII defines 7 classification rules based on analyte risk, intended use, and device type. Devices are classified into four risk classes:

Under IVDD, ~80% of IVDs were self-certified. Under IVDR, ~80% require notified body involvement. Try the IVDR classification wizard →

Class D examples

The highest-risk IVD devices include:

• Blood grouping systems (ABO, Rh, Kell, Kidd, Duffy)
• HIV, HTLV, Hepatitis B/C/D markers
• Blood screening for transfusion safety
• Variant Creutzfeldt-Jakob disease detection
• Rubella and toxoplasmosis screening for congenital infections

Conformity assessment

• Class A: Self-declaration — no notified body (except sterile devices)
• Class B: Quality management system review by notified body
• Class C: Full quality assurance or type examination + production verification
• Class D: Full quality assurance with design dossier review + EU Reference Laboratory verification

Transition timeline

• 26 May 2022: IVDR date of application
• 26 May 2025: Extended transition for Class D devices
• 26 May 2026: Extended transition for Class C devices
• 26 May 2027: Extended transition for Class B and sterile Class A devices
• 26 May 2028: Final deadline — all IVDs must comply with IVDR