The Medical Devices Regulation in Europe

14 May 2018


In 2008, a conference was initiated by the European Commission on the medical devices regulation, which resulted in more than 200 remarks and suggestions for revision of the regulation. Therefore, the European Commission proposed a plan in 2012, of revising the medical devices regulation framework, where the existing directives were going to be replaced.
Read here what these modifications consist of.

On May 5th 2017, the medical devices regulation was published and came into force on May 25th 2017. This regulation is meant to last until May 26th 2020, which means that current manufacturers of medical devices had to meet the requirements as soon as the medical devices regulation was inserted. As a result of weaknesses in the old regulation as well as the significant scientific and technological evolvement in the medical devices industry over the years, it was necessary to adapt the European Legislation.

New requirements

The European Commission revised the medical devices regulation with new requirements, keeping three key objectives in mind:

  • Confidence for patients, consumers and healthcare professionals, with the medical devices they use every day.
  • Industry where products can enter the market that are safe, effective, innovative and, as efficient and quickly as possible.
  • Availability for innovative medical devices companies to attract investors, estimate costs and anticipate procedures.

Medical devices regulation

The current Medical Devices Regulation differs from its previous directives. The differences of the regulation includes the following:

  • Product range expansion: The medical devices regulation resulted in an expansion of its product range in the medical devices industry. This means that certain products that were not categorised in this sector previously, would fall under the definition of medical devices, such as contact lenses.
  • Reclassification of medical devices: The medical devices regulation requires manufactures to apply the new rules on their devices. Hereby, the manufactures should keep their technical documentation up to date based on the new requirements. With the new regulation, class III and implantable devices got higher clinical requirements and a regular scrutiny process. As a result of higher requirements, an increase in time and resources are necessary to conduct certain studies and to keep up their documentation.
  • Clinical evidence: Based on the reinforcement of the new regulations on clinical evidence, manufactures will have to re-prepare their clinical evaluations.
  • Transparency: With the new regulations, transparency is improved as a result of a comprehensive European database of the medical devices industry. Furthermore there is a  device traceability system based on “Unique Device Identification” which also contributes to this improvement.
  • High-risk control medical devices: Next to the improved transparency, the control on high-risk medical devices has been improved as well. This is done by a new “pre-maket scrutiny mechanism’’, where European experts are involved. In this way safety will be secured.
  • Coordination European countries: Another key element that includes this regulation, is the enhancement of vigilance and market surveillance. As soon as medical devices are vacant for use, manufactures can collect data about their performance. In the fields of vigilance and market surveillance, the coordination mechanisms between the European countries has been improved.
  • Responsible person: The new regulation requires all the manufacturing organisations to have a responsible person for regulatory compliance. This person possesses the requisite expertise in the medical devices industry.

Medical devices regulation necessity

As a result of significant scientific and technological evolvement in the medical devices industry as well as weaknesses in the old regulation, it was necessary to adapt the European Legislation. With the new requirements, the medical devices regulation meets the changes and prevents problems within this industry. In the future there will occur more changes within this industry whereas there will be a need of adapting the medical devices regulation, because the safety of medical devices users comes first.


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