MedTech Europe Statement on the Implant Files

Posted on 19.12.2018

Providing products that work and are safe is at the core of what we do as the medical device industry. We continue to uphold our commitment and responsibility in providing safe medical devices that help save and improve people’s lives.

The ICIJ investigation shares the same fundamental belief that it is important to provide products that work and are safe. However, their analysis, comments, conclusions and perspectives, on how the industry operates does not align with ours.

Delivering safe, effective products, as our industry does, means that every day millions of people benefit from medical devices. They live healthier, more productive and more independent lives. And this contribution to patients’ wellbeing, the ICIJ have unfortunately continuously omitted to address.

We have a genuine responsibility to the patients we serve. We have always supported legislation that better serves patients and provides a predictable, sustainable and appropriate regulatory environment.

Medical devices undergo strict regulatory controls that give patients continued access while safeguarding high levels of safety in Europe. The new Medical Device Regulation (MDR) provides an even greater strength in maintaining high standards in this already highly-regulated industry. The MDR is fit for purpose and quite possibly one of the most modern and stringent set of rules in the world.

Industry is strongly committed to the new Medical Device Regulation and its full and timely implementation. Medical device manufacturers will continue to invest resources in order to fully comply with these new requirements.