Medical Devices and EU Regulations

Medical devices play a critical role in the diagnosis, treatment, and care of patients. The safe and effective use of these devices is of great importance for the quality of healthcare services. Within the European Union (EU), the placing on the market and use of these devices was previously regulated by the 93/42/EEC Medical Devices Directive (MDD) and is now comprehensively addressed under the Regulation (EU) 2017/745 on Medical Devices (MDR).

The New EU Medical Devices Regulation (MDR)

Regulation (EU) 2017/745 (MDR) was adopted in April 2017 and came into force on 25 May 2017. MDR replaced the previous 93/42/EEC Medical Devices Directive (MDD) and the 90/385/EEC Active Implantable Medical Devices Directive (AIMDD).

Key innovations introduced by MDR include:

  • Extended Scope: Devices for aesthetic purposes and certain non-medical products are now covered.
  • Clinical Evidence Requirements: Stricter obligations to provide stronger clinical data and evidence.
  • Post-Market Surveillance: Manufacturers must closely monitor the performance and safety of devices after they are placed on the market.
  • EUDAMED Database: A public database containing safety and performance information for all devices.
  • Notified Bodies: Strengthened competence requirements and stricter supervision.
  • Unique Device Identification (UDI): Mandatory for traceability and more effective management of recall processes.

Classification of Medical Devices

Under Directive 93/42/EEC, medical devices were classified into three risk-based categories. With MDR, the classification has become more detailed. In general:

  1. Class I – Low-risk devices (e.g., simple thermometers).
  2. Class IIa & IIb – Medium-risk devices (e.g., some diagnostic devices).
  3. Class III – High-risk devices (e.g., pacemakers).

The device class determines the applicable conformity assessment procedure and the complexity of the certification process.

Technical Documentation and Its Importance

Under MDR, manufacturers must prepare comprehensive Technical Documentation (Technical File) in order to place their products on the EU market.

Contents of the Technical File:

  1. Product Description and Classification – Device purpose, scope, and risk class.
  2. Risk Analysis – Assessment of potential hazards during use.
  3. Design and Performance Data – Design details, instructions for use, and performance evidence.
  4. Quality Management System (QMS) Information – Production processes, control, and monitoring methods.
  5. Clinical Data – Clinical studies, test results, and safety evaluations.
  6. Post-Market Surveillance and Recall Plans – Mechanisms for monitoring after market placement.
  7. Technical Documents and Test Reports – All required technical and laboratory reports.

Why It Matters:

  • Mandatory for compliance with EU legislation.
  • Provides objective evidence of device safety and performance.
  • A key requirement for obtaining CE marking.
  • Serves as a reference during market surveillance and potential recall processes.