EU Medical Device Regulation (2017/745)
Regulation (EU) 2017/745, commonly known as the EU MDR, replaced the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). The MDR entered into force on 25 May 2017 and became fully applicable on 26 May 2021, with extended transition periods for certain devices. It establishes a comprehensive regulatory framework for medical devices placed on the European market, covering classification, conformity assessment, clinical evaluation, post-market surveillance, and vigilance.
Classification Rules (Annex VIII)
The MDR classifies medical devices into four risk classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Classification is determined by the device's intended purpose and inherent risks, using 22 classification rules defined in Annex VIII.
| Rules | Category | Examples |
|---|---|---|
| Rules 1-4 | Non-invasive devices | Wound dressings, collection devices, blood bags, non-invasive electrodes |
| Rules 5-8 | Invasive devices | Surgical instruments, implants, stents, heart valves, hip replacements |
| Rules 9-13 | Active devices | Diagnostic imaging, patient monitors, infusion pumps, defibrillators, radiation therapy |
| Rules 14-22 | Special rules | Devices incorporating medicinal substances, contraceptive/STI barrier devices, disinfectants, devices with nanomaterials, software (Rule 11), substances absorbed by the body |
Rule 11 (Software): Software intended to provide information used for diagnostic or therapeutic decisions is classified as Class IIa, except: Class IIb if decisions may cause serious deterioration or surgical intervention; Class III if decisions may cause death or irreversible deterioration. Software for monitoring physiological processes is Class IIa minimum. All other software is Class I.
Conformity Assessment Procedures
Before placing a device on the EU market, manufacturers must undergo a conformity assessment procedure appropriate to the device's risk class. The procedures are defined in Annexes IX through XI of the MDR:
- Class I (non-sterile, non-measuring): Self-declaration of conformity by the manufacturer. No notified body involvement required. Manufacturer must establish a QMS, prepare technical documentation, and issue an EU Declaration of Conformity.
- Class I (sterile or measuring function), Class IIa: Notified body assessment required. Annex IX (QMS + technical documentation assessment) or Annex XI (product conformity verification) may be used.
- Class IIb: Notified body assessment of QMS and technical documentation under Annex IX. For implantable devices, clinical data assessment by the notified body is mandatory.
- Class III: Full notified body assessment under Annex IX including QMS audit and technical documentation review for each device. Clinical investigation data is typically required. For certain Class III devices, an expert panel consultation may be triggered.
Technical Documentation Requirements
Annex II and Annex III of the MDR define the requirements for technical documentation. The documentation must contain:
- Device description and specification, including variants and accessories
- Information supplied by the manufacturer (labeling, IFU)
- Design and manufacturing information
- General safety and performance requirements (Annex I) and solutions adopted
- Benefit-risk analysis and risk management (ISO 14971)
- Product verification and validation (bench testing, pre-clinical, clinical)
- Clinical evaluation report per Article 61 and Annex XIV
- Post-market surveillance plan (Annex III)
- Post-market clinical follow-up (PMCF) plan and evaluation report
Unique Device Identification (UDI)
Article 27 and Annex VI Part C of the MDR establish the UDI system. Each device must bear a UDI on its label and all higher packaging levels. The UDI consists of:
- UDI-DI (Device Identifier): Identifies the manufacturer and the specific version or model of the device
- UDI-PI (Production Identifier): Identifies the production unit (lot/batch number, serial number, expiration date, manufacturing date)
UDI carriers must be in both AIDC (Automatic Identification and Data Capture, e.g., barcode or RFID) and HRI (Human Readable Interpretation) format. Implantable devices additionally require the UDI on the device itself where feasible.
EUDAMED Database
EUDAMED (European Database on Medical Devices) is the central IT system established under Article 33 of the MDR. When fully operational, EUDAMED will integrate six modules:
- Actor registration (manufacturers, authorized representatives, importers)
- UDI/device registration
- Notified bodies and certificates
- Clinical investigations
- Vigilance and post-market surveillance
- Market surveillance
Until EUDAMED is fully functional, relevant provisions of the corresponding directives continue to apply. Manufacturers should monitor the European Commission's announcements regarding EUDAMED module launch dates and mandatory registration deadlines.
Notified Body Roles
Notified bodies are organizations designated by EU Member States to assess conformity of medical devices before they are placed on the market. Under the MDR, notified bodies must:
- Be designated under the MDR (not the previous directives) through a rigorous joint assessment process
- Conduct QMS audits (announced and unannounced) at manufacturer facilities
- Review technical documentation and clinical evidence
- Issue EU certificates (EC certificates under the MDR) that are valid for a maximum of 5 years
- Conduct post-certification surveillance activities
- Report to competent authorities on significant findings, certificates issued/refused/restricted