EU Medical devices: more safety, more traceability

After a long and tenacious struggle, the path for the new European legal framework for medical devices and in vitro diagnostics is finally free. The corresponding regulations were adopted today in the European Parliament at second reading.

For many years the EU legislators had intensively struggled with the so-called “stakeholders” for the several hundred-page-long mammoth work. In a press release, the European Commission has now expressly welcomed the European Parliament’s approval of its proposals on medical devices and in vitro diagnostics. The two new regulations contain a number of improvements for this market sector:

Among other things, they provide for stricter controls on particularly risky products, such as implants, and require that an expert pool be consulted at EU level before the product is placed on the market.

Both clinical trials with medical devices as well as those authorized to approve the placing of medical devices on the market are subject to stricter supervision.

In addition, certain aesthetic purposes and formerly unregulated medical products are also subject to the new regulations, such as colored contact lenses which do not cause any visual correction.

The transparency of the market and the traceability of the individual products are to be significantly improved. In the future, each product will have a unique product number so that it can be identified via the new European database for medical devices EUDAMED.

Last but not least, the safety and market monitoring of the products are intensified. If a product is available on the market, the manufacturer will need to collect data on its performance. The EU Member States will coordinate more closely in market surveillance.

The EU Commission is convinced that the two new regulations will help ensure that all medical devices, from heart valves to stitching and artificial hip joints, function safely and reliably.

Message from the EU Parliament (Download PDF)

Download (PDF, 124KB)

Message from the EU Commission (Download PDF)

Download (PDF, 75KB)

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