EU · Regulation 2017/745

EU MDR

Medical Device Regulation

Replaces Directive 93/42/EEC · Fully applicable since 26 May 2021

Overview

The EU Medical Device Regulation (MDR) 2017/745 is the primary legislation governing the safety and performance of medical devices placed on the European market. It replaced the previous Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.

MDR introduces significantly stricter requirements for clinical evidence, post-market surveillance, traceability (through UDI), and transparency (via EUDAMED). It applies to all medical devices — from simple wound dressings to complex implantable systems and standalone software (SaMD).

Classification under MDR follows Annex VIII, which contains 22 rules organized by device type: non-invasive devices (Rules 1–4), invasive devices (Rules 5–8), active devices (Rules 9–13), and special rules (Rules 14–22). Each rule maps to one of four risk classes.

Scope & Applicability

→Applies to all medical devices and accessories placed on the EU/EEA market
→Covers devices with a medical purpose as defined in Article 2(1)
→Includes standalone software (SaMD) that qualifies as a medical device
→Applies to devices manufactured and used within the same health institution (with exemptions)
→Does not cover in vitro diagnostic devices (covered by IVDR 2017/746)
→Does not cover medicinal products, cosmetics, or food (covered by other EU regulations)

Classification Classes

I

Lowest risk. Most Class I devices can be self-certified by the manufacturer. Notified Body involvement only required for devices with a measuring function (Im), supplied sterile (Is), or reusable surgical instruments (Ir).

Examples

• Wheelchairs
• Stethoscopes
• Examination gloves
• Hospital beds
• Non-invasive electrodes

Requirements

✓Declaration of Conformity (DoC)
✓Technical documentation per Annex II & III
✓Quality Management System
✓UDI assignment and EUDAMED registration
✓No Notified Body audit (unless Is/Im/Ir)

IIa

Medium-low risk. Requires Notified Body assessment of either a full QMS (Annex IX) or Type Examination (Annex X) plus production quality assurance (Annex XI). Clinical evaluation must demonstrate safety and performance.

Examples

• Hearing aids
• Blood transfusion tubes
• Contact lenses
• Ultrasound diagnostic devices
• Surgical clamps

Requirements

✓Notified Body conformity assessment
✓Clinical Evaluation Report (CER)
✓Post-Market Surveillance plan
✓PSUR every 2 years
✓UDI registration in EUDAMED

IIb

Medium-high risk. Requires full QMS assessment and scrutiny of clinical evidence. A Summary of Safety and Clinical Performance (SSCP) must be published in EUDAMED.

Examples

• Ventilators
• Bone fixation plates
• X-ray machines
• Infusion pumps
• Condoms

Requirements

✓Full QMS assessed by Notified Body (Annex IX)
✓SSCP published in EUDAMED
✓Annual PSUR
✓Clinical investigation may be required
✓Increased PMS obligations

III

Highest risk. Strictest conformity assessment pathway. Requires full QMS audit plus design dossier scrutiny. For implantable or life-sustaining devices, clinical investigation data is typically required.

Examples

• Heart valves
• Hip implants
• Coronary stents
• Pacemakers
• SaMD for life-threatening conditions

Requirements

✓Annex IX full QMS + design dossier audit
✓SSCP mandatory in EUDAMED
✓Annual PSUR
✓Clinical investigation data typically required
✓Expert panel consultation may be required

Key Rules & Concepts

Non-Invasive Devices (Rules 1–4)

→Rule 1 — Default: all non-invasive devices not covered by other rules are Class I
→Rule 2 — Channelling or storing: devices for channelling blood/body liquids for infusion are Class IIa
→Rule 3 — Modifying biological/chemical composition: devices that modify blood, body liquids, or cells for infusion are up-classified based on filtration type
→Rule 4 — Contact with injured skin: Class I for minor wounds, IIa/IIb for secondary intention healing, chronic wounds, or burns

Invasive Devices (Rules 5–8)

→Rule 5 — Body orifice (non-surgical): Class I if transient, IIa if short-term, IIb if long-term
→Rule 6 — Surgically invasive (transient): Class IIa by default, III if connected to CNS/heart or supplies energy
→Rule 7 — Surgically invasive (short-term): Class IIa, or IIb/III depending on contact with vital organs
→Rule 8 — Implantable / long-term surgically invasive: Class IIb by default, Class III for CNS/heart contact, joint replacements, or breast implants

Active Devices (Rules 9–13)

→Rule 9 — Active therapeutic devices: Class IIa, or IIb if potentially dangerous energy exchange
→Rule 10 — Active diagnostic devices: Class IIa, or IIb for monitoring vital physiological parameters where variations could result in danger
→Rule 11 — Software (SaMD): Class IIa for monitoring/decision support, IIb for influencing serious decisions, III for life-threatening conditions
→Rule 12 — Active devices administering/removing medicines: Class IIa, or IIb if potentially hazardous
→Rule 13 — Other active devices: Class I default

Special Rules (Rules 14–22)

→Rule 14 — Contraceptive/STI prevention devices: Class IIb (implantable: III)
→Rule 15 — Disinfection/sterilisation of devices: Class IIa (contact lenses/invasive: IIb)
→Rule 16 — Non-active blood bag/X-ray film devices: Class IIb
→Rule 17 — Devices incorporating nanomaterial: Class III (with certain exceptions)
→Rule 18 — Blood bags and derived devices: Class IIb
→Rule 19 — Devices incorporating or consisting of nanomaterial for ingestion/inhalation: Risk-based classification
→Rule 20 — Invasive devices in body orifice applying ionising radiation: Class IIb
→Rule 21 — Devices with integrated medicinal substance: Class III
→Rule 22 — Active therapeutic device with integrated diagnostic function: highest class applies