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Medical Devices Directives

Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe

The revision of the EU Medical Devices Directives: Eucomed's position of four key issues (April 2014)

The revision of the EU Medical Devices Directives has entered a critical phase. The European Parliament has finalised its report and must now work together with the EU Council towards agreement on a final text. The medical device industry has identified four key issues which it believes warrant special attention during this process. These include:

  • Revised clinical requirements
  • The Commission’s proposed “scrutiny procedure”
  • The restriction of “hazardous substances”
  • The re-use of single-use medical devices

Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe (January 2013)

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.

The European Medical Device industry recognizes that the system needs an overhaul due to increased expectations and technological advances, and acknowledges that change is necessary to improve Europe’s Medical Device regulatory framework. In particular, the European Medical Device industry unanimously agrees that incidents like the fraudulent PIP breast implant case should never happen again.

In the global context, let us not forget that Europe has been known for providing its citizens with timely access to safe technology thanks to the effective decentralised approval system. The European system (see also Appendix 1) forms a significant basis for other national regulatory frameworks around the globe (e.g. Japan, Australia, Canada) because of its efficiency in providing lifesaving and life-enhancing technologies to patients and doctors while guaranteeing a high level of safety.

Various recent reports from respected academics and researchers have shown that lifesaving and life-enhancing medical technologies are made available to European patients on average of three to five years earlier than those in the United States - and this without compromising safety.

We are convinced that Europe can remain in this leading situation with the support of an improved decentralised, device-specific regulatory framework that assures safety, encourages cost-effective innovation and ensures that an incident such as the PIP case will not happen again.

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;
  • maintains an environment that encourages and keeps 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.

Read Eucomed’s full position paper here.