Medical devices

GDV welcomes EU Members States’ rejection of compulsory insurance

The safety of medical devices is of particular concern to the insurance industry. The German Insurance Association (GDV) has therefore followed the discussions on regulations on medical devices and on in vitro diagnostic medical devices with great interest. While the German insurers welcomed the proposals and support the position taken by the Council of the European Union, the GDV opposes the European Parliament’s proposal to introduce a compulsory liability insurance for manufacturers of medical devices.

The GDV strongly welcomes the Partial General Approach as adopted by the Council on 19 June 2015. By urging manufacturers to consider taking out appropriate insurance and not introducing a compulsory liability insurance, the Council enables manufacturers to still benefit from the advantages of tailor-made insurance cover. This is a decision in favor of patient safety.

At the same time, the GDV is very concerned by the proposed introduction of a compulsory liability insurance as stipulated in the legislative resolution of the European Parliament of 2 April 2014. This is unnecessary. In addition, a compulsory insurance for the manufacturer with low to medium risk would result in many cases significantly higher insurance premiums. Product safety will also not be improved by this measure.

The GDV’s complete comments before the trialogue negotiations are available in the download section.


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GDV comments on

a Regulation on medical devices