Medical Devices Directives


Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of the relevant Directive and affix a CE mark to their device. 

These Directives, the core legal framework in the EU, relate to the safety and performance of medical technology and were harmonized in the 1990s. Serving the industry well for many years, they form the foundation of Europe’s regulatory framework and are essential to the safe and timely delivery of the latest technology to European patients.

The medical devices directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision had several purposes:

  • to ensure a consistently high level of health and safety protection for EU citizens using these products,
  • to maintain the free and fair trade of the products throughout the EU,
  • to adapt legislation to the significant technological and scientific progress in this sector over the last 20 years.

The planned revisions would extend the scope for legislation, improve supervision of independent assessment bodies and set stricter requirements for clinical evidence. The proposed legislation will be in the form of regulations, and so will be legally binding and directly applicable in all EU Member States (the current directives have been criticized for being inconsistently interpreted and implemented, leading to different levels of patient and public health protection in the EU).

A clear and predictable regulatory framework

The European medical device industry recognizes that Europe’s regulatory framework needs an overhaul to strengthen the system that has been, up until this point, the world’s fastest in providing life-saving technologies without compromising safety. The rules must be fit for purpose, more transparent, and better adapted to scientific and technological progress. MedTech Europe supports revised legislation that speeds up approval processes, strengthens harmonised standards, and creates an integrated approach that is better coordinated and managed.

We believe that it is in Europe’s best interest to have a clear, predictable and effective regulatory system that:

  • guarantees the highest level of safety and quality for patients,
  • is consistently implemented across the EU,
  • ensures timely access to the latest and best in technology and innovation,
  • enjoys the trust of its stakeholders,
  • contributes to the sustainability of national healthcare systems,
  • employs a decentralised regulatory approach that allows medtech minds to do what they do best: produce life-saving, innovative medical devices,
  • ensures that all notified bodies, which conduct conformity assessments, are transparent, competent and operate to the same high level,
  • coordinates more on vigilance and the establishment of a central registration database
  • maintains an environment that encourages and keeps research and innovation in Europe.

 

 
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