A European Commission proposal to tighten the rules for medical devices and in vitro diagnostic medical devices has been approved by the European Parliament. Giving each device a unique identification number - the unique device identifier (UDI) - should make it easier to track individual medical devices within the European Union. It also introduces a database where information on the life cycle of all medical devices available within the European Union can be found.
Several medical device scandals have been in the news in recent years. For example, breast implants Poly Implant Prothèse were found to leak, which could endanger the health of wearers. Globally, 300,000 women worldwide had these implants. In addition, in 2010, manufacturer DePuy withdrew its metal-on-metal artificial hip ASR from the market after metal particles were found to be released in some cases, which can spread through the human body.
Confidence in medical devices eroded
The European Commission argues that these scandals have not only eroded patients' and healthcare providers' confidence in the safety of medical devices, but also revealed weaknesses in the current legal system. These weaknesses the European Commission intends to address with the new regulation.
A total of two new European laws have been approved by the European Parliament. These new laws replace three current European directives in the field of medical devices and in-vitro diagnostic medical devices. Unlike a directive, a European law applies directly to EU member states without the need for transposition into national legislation. The new laws have yet to be published. The regulation for medical devices comes into force three years after publication, while the regulation for in vitro diagnostic medical devices comes into force five years after publication.
New regulations
The new regulations cover:
- Better protection of public health and patient safety - Devices that pose a relatively high risk will be subject to stricter regulation under the European Commission's proposal. These include certain cosmetic devices such as coloured contact lenses and equipment for performing liposuction. For example, some devices are only suitable for single use and are therefore not allowed to be used multiple times. In addition, the European Commission wants to tighten rules for the clinical evaluation and clinical research of devices, as well as performance testing requirements for in vitro diagnostic medical devices.
- A comprehensive European database for medical devices - This database should provide a better picture of the life cycle of all medical products available on the European market. Much of this information will be made public, including a summary of the safety and performance of Class III and implantable medical devices. The database will be called EUDAMED, will be set up and maintained by the European Commission and should be ready in early 2020.
- New identification system for medical devices - An identification system based on unique identification numbers should make tracking medical devices easier.
- An implant card - These cards contain all information on implanted medical devices. The implant cards should make information about implants more easily available and accessible to patients.
- A financial mechanism to pay out compensation - A new financial system should ensure that patients receive compensation if a defective device is implanted in them. The European Commission wants to require manufacturers to keep sufficient financial resources behind them to pay compensation if they are found to be responsible for defects. This financial compensation will depend on the risk faced by patients, the type of device implanted and the size of the manufacturer. The European Commission also wants patients to be able to receive compensation in case of bankruptcy.
Reduce administrative burden
The European Commission says the new rules will reduce the administrative burden for medical device manufacturers. For instance, manufacturers will now have to register devices only once in the European Union. Currently, a device must be registered separately in each EU member state where the product is marketed. In addition, the European Commission wants to restore confidence in the safety of medical devices damaged by the aforementioned incidents with the help of the stricter rules.
By: Wouter Hoeffnagel
Photos: Shutterstock
