Medical Device Regulation (MDR)

  • New rules for the classification of medical devices
  • More safety for patients
  • Short-term bottlenecks in the availability of medical products

The MDR project in brief

Scandals with medical devices (e.g. breast implants filled with soy oil, which had cracks or leaks, causing inflammation and swelling in patients) led to tighter regulation and legal requirements for medical products in Europe. In the future, manufacturers will have to prove the usefulness and convenience of their high-risk products more accurately with clinical studies, and these products will be subject to an additional control procedure. In addition, each individual product must be traceable and identifiable through the introduction of a Unique Device Identification (UDI) number. You will find further information and changes to the MDR project under the link at the bottom of the text.

These new regulations entered into force on 25 May 2017 and must be implemented by 26 May 2020 at the latest.

Opportunities and risks

Manufacturers may need to adapt and improve their products in order to continue trading on the European market. In the long term, this should lead to an improvement in the quality of medical products and a reduction in the risk to patients.

In the short term, however, the MDR project can lead to bottlenecks in the availability of medical devices, because on the one hand products that do not conform to the rules have to be adapted, and on the other hand the notified bodies (certification bodies that test medical devices) are busy testing the products. Both patients and smaller manufacturers suffer as a result.

These new regulations can also represent a major hurdle for start-ups in the industry.

Implementation at Xatena

Our goal is to gain master data with MDR relevant attributes. Suppliers and buyers benefit from digital networking and save a lot of time.

Further information about the MDR project

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

Photo by Piron Guillaume on Unsplash

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