Medical devices

Controversial discussion on EU-wide compulsory insurance very critical

In September 2012, the European Commission adopted proposals for Regulations on medical devices (PDF) and on in vitro diagnostic medical devices (PDF). While insurers welcomed the proposals, European co-legislators have since discussed several critical amendments, above all the introduction of compulsory liability insurance for manufacturers of medical devices. German insurers oppose compulsory insurance for several reasons. Among others, it would limit the possibility to tailor the insurance coverage and thus lead to higher costs for manufacturers. Ultimately, the safety of patients would not be improved.

On 2 April 2014, the European Parliament adopted its controversial legislative resolutions on both dossiers. Both the legislative Resolutions on medical devices and on in-vitro diagnostic medical devices require manufacturers to purchase liability insurance. This is also a reaction to the 2011 scandal on defective breast implants. However, in addition to other critical points, even compulsory liability insurance does not cover intentionally negligent or fraudulent behaviour. In addition, also insolvency cannot be addressed through liability insurance. The question of compulsory insurance is currently also discussed among Member States (PDF).

While being very critical on compulsory insurance, insurers welcome the measures to regulate the access to market, to control the manufacturing process and to monitor the market as proposed by the Commission.

The GDV’s complete position paper on the current state of play of the discussions is available in the download section.


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Position Paper

Controversial discussion on EU-wide compulsory insurance very critical