Regulatory Focus; Medical Device Regulations

December 18, 2017

On 25th May, 2017, the new European Medical Device Regulation (MDR) entered into force, replacing existing directives. The new regulation applies to manufacturers selling medical devices in Europe and has a transition period of 3 years for all manufacturers to update their technical documentation and processes to comply with new requirements, aiming for a full transition by 2020.

The MDR will require further inspection of technical documentation, place rigorous requirements on clinical evaluation and post-market follow-ups and will increase traceability of devices through the supply chain. The aim is to provide a more robust EU legislation framework to allow for greater protection of public health and safety.

The new regulation provides a variety of improvements to the current system, including:

  • A new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • Increased transparency and traceability using a comprehensive EU database on medical devices
  • Intensified post-market surveillance requirements for manufacturers
  • Improved coordination of vigilance and market surveillance between EU countires


Why the change?

Many problems with the inconsistent interpretation of the current directives have been highlighted recently, which has been detrimental to the confidence of patients, consumers and healthcare professionals.

The new MDR has therefore been put into place to prevent such problems transpiring again by strengthening the safety procedures surrounding all medical devices available within the EU. The new regulations will ensure:

1.) A consistently high level of health and safety protection for EU citizens using products.

2.) Free and fair trade of products throughout the EU.

3.) The adaptation of EU legislation to the important technological and scientific progress taking place in this sector.


For further information on the new regulations, please click here.

To find out more about how Perfectus Biomed can support research and development programmes relating to infection control on medical devices, and to see the range of standard test methodologies that we offer, please visit our website.

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