Document paper New medtech regulations

The revision of the EU Medical Devices Directives

The European medical device industry is a critical provider of innovative, effective and safe healthcare
solutions for an increasing number of patients in Europe. Through its healthcare innovations, the
industry contributes to ensuring sustainable and accessible healthcare systems throughout Europe.

Industry recognizes that the regulatory system needs an overhaul due to increased expectations and
technological advances, and acknowledges that positive change is necessary to improve Europe’s
medical device regulatory framework.


We strongly 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 for patients;
  • ensures timely access to the latest innovative technologies;
  • enjoys the trust of its stakeholders;
  • contributes to the sustainability of national healthcare systems; and
  • maintains an environment that encourages and retains research and innovation in Europe.

We welcome the majority of the recommended measures in the Commission’s proposal for the revision of the EU Medical Devices Directives (MDD), and acknowledge their importance in achieving the above mentioned objectives.

In this position paper, we wish to focus on four important issues for the medical devices sector that have become key concerns in the revision of the legislation: revised clinical requirements, the introduction of a pre-market scrutiny procedure, the restriction of hazardous substances, and the reuse of single-use devices.


  • The introduction of a pre-market ‘scrutiny’ procedure.

“Eucomed encourages the EU Council to replace the European Commission’s proposed scrutiny procedure with a “Reinforced Control Procedure.” This system should be built into the upgraded notified body approval system, rather than added on after it. This will avoid any sort of cherry-picking or random ‘needle-in-the-haystack’ approach to improving safety.”

  • Revised clinical requirements.

“Eucomed encourages the EU Council to closely adhere to a devicespecific approach, setting clear, attainable and scientifically valid clinical requirements for devices, and avoiding a ‘one-size-fits-all’ system. Industry believes that with fine-tuning of certain elements, the European Commission’s proposal offers a balanced and appropriate approach to clinical requirements for medical devices.”

  • The restriction of ‘hazardous substances’.

“Eucomed encourages the EU Council to support the European Commission’s proposal on the use of hazardous substances in medical devices. The proposal strengthens the current rules on hazardous substances in medical devices and guarantees a higher level of patient safety while ensuring a balanced approach. The provisions foreseen allow for the replacement of hazardous substances when alternatives with a more positive risk/benefit balance are available.”

  • The re-use of single-use medical devices.

“Eucomed encourages the EU Council to support the European Commission’s proposal on the re-use of single-use devices, which will ensure a balanced approach that puts patient safety first and can be practically implemented.”

Posted on 27.07.2015

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