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EU Medical Device Regulation (MDR)

Effective May 26, 2021, following a four year transition period.

The new MDR replaced the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).

The biggest changes:

  • New reporting and documentation
  • Lifecycle approach
  • Product-specific quality and risk management systems

The MDR applies to medical devices in the European Economic Area. Although it is focused primarily on manufacturers, it also affects users and distributors of medical devices.

Testing and documentation are required evidence for medical devices.

Hohenstein tests medical devices for efficacy and safety.

Many Hohenstein tests are prerequisites for conformity of a medical device ("approval") in the European market. Our tests are used in:

  • Technical documentation
  • Risk evaluations
  • Clinical assessments

We also provide customized testing outside of common standards.

A medical device is an instrument, apparatus, appliance, implant, tool, material, software, or other article intended by the manufacturer to be used alone or in combination for humans for one or more of the following specific medical purposes:

  • Diagnosis
  • Prevention
  • Monitoring
  • Prediction
  • Prognosis
  • Treatment
  • Alleviation
  • Investigation

of disease, injury or disability. (e.g., textiles that have a health-promoting purpose and are declared to have such a purpose)

It also includes products specifically intended for the cleaning, disinfection or sterilization of devices.

The MDR has changed the scope of the medical device legislation and extended its application to all economic operators in the supply chain (manufacturers, authorized representatives, importers and distributors).

  • The new MDR emphasizes a lifecycle-based safety approach - to be supported by clinical data and new requirements such as transparency and traceability
  • The manufacturer must establish and prove quality management and risk management systems specific to the product and conduct a clinical evaluation
  • Reports must include all undesirable effects, defects and malfunctions, not just life-threatening incidents
  • Stricter requirements for reprocessing
  • Evidence of comprehensive clinical evaluations

Manufacturer's tasks for a class I textile medical device:

  • Classification as a medical device
  • Classification as Class I product
  • Process before marketing:
    - Compliance with general safety and performance requirements
    - Conducting the clinical evaluation
    - Creating the technical documentation
    (Involvement of the Notified Body, only for Class I sterile devices, devices with measuring function, reusable surgical instruments)
    - Operating instructions and labelling of the product
  • Verification of compliance for manufacturers
  • Affixing the CE mark
  • Registration of the medical device and the manufacturer in Eudamed
  • Evaluation of the experience from post-market surveillance:
    - Review of the collected data from the PMS
    - Vigilance
    - Non-compliant products
Ben Mead
Managing Director
Hohenstein Americas