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The Medical Devices Regulation Is Coming! Are You Ready?

November 19, 2019

Thousands of health apps and devices that use software are available in the market without rigorous checks. Fortunately for everyone’s safety, the Medical Devices Regulation 2020 is coming to improve industry standards.

If you thought the world of embedded systems has been standing still, you’ve been missing a lot. Not only are these systems on the rise, they’ve been expanding their influence across more and more industries – including medical devices.


Regulation in this industry has not really previously considered software as a medical device. This means that thousands of health apps and devices that use software, like insulin pumps, are available in the market without rigorous checks. Yikes! Fortunately for everyone’s safety, the Medical Devices Regulation 2020, or MDR for short, is coming on May 2020 to improve industry standards.


This new set of regulations states that all medical devices will need to be re-assessed to ensure that they comply with the new regulatory certification. For example, devices that were self-certified will need their requirements re-submitted and their documentation, labelling and clinical information updated.


A new database will be created – the Eudamed – and it will have all kinds of medical devices information on conformity assessments, certificates and investigations, (post-) market surveillance and vigilance. This info should be provided and kept updated by manufacturers.


Whilst the MDR aims to ensure that everything is safe and sound, there’s no denying that these changes will pose quite a challenge for everyone involved in the medical devices industry. New classification rules will increase the number of devices that have to be submitted to the evaluation process, which may mean that certification processes will take longer and cause delays in launching any new device.


Certainly, manufacturers will have a lot of tasks at hand, for example:

  • Set up new quality processes to ensure the safety of devices.
  • Implement appropriate systems to monitor post-market performance and keep systems updated.
  • Install systems to record and report incidents and corrective actions.
  • Establish, document, implement and maintain a risk management system and a quality management system with information acquired through post-market surveillance.
  • Provide patients with as much information as possible about the device, its potential side effects and alternatives.


And many others.


Manufacturers will also have to invest more time and money to launch and maintain devices. They’ll now need to present a summary of safety and clinical performance which should be based on clinical data sourced from investigations carried out under a sponsor’s supervision.


Just as importantly, medical device companies based in the US and looking to sell their devices in Europe will have to reassess their relevant devices against the MDR.


With non-compliant risking injury to a business’ reputation elsewhere, for its other products and services, now is the time for the industry to get in line.


For more on what the new MDR means and how to get prepared, check out our white paper.

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Medical Devices