Liability for medical devices

Safety net for incidents caused by medical devices in CEE countries

 Doctors do everything in their power to keep their patients safe and sound. But can they fully rely on the medical devices they use? Unfortunately, doctors and patients are both exposed to the safety of medical devices. bnt attorneys in CEE have conducted thorough research in order to excavate every detail of the EU safety net for medical incidents.

A developed and harmonized vigilance system is implemented in the EU in order to evaluate adverse incidents, collect and preserve information and notify doctors, patients, distributors or concerned third parties in time.

At local level, hospitals, manufacturers, distributors or even patients can report incidents or serious risks directly to the competent authority and also to the manufacturer. Hungary and Lithuania require health service providers to appoint a designated person to report incidents. Health service providers and manufacturers maintain a system of incident reports as part of their quality management system. Manufacturers should also report any field safety corrective action and affected users and customers should be notified by a safety notice from the manufacturer or its authorized representative.

It is important to note that a report of an incident by the manufacturer to the competent national authority does not constitute an admission of liability for the incident or its consequences. The manufacturer should immediately investigate the incident, evaluate the risks and take the necessary corrective action. Failure notification can result in fines being imposed and even suspension or restriction of distribution of the device.

Notifying the relevant authorities has been almost entirely digitized, with most forms capable of submission electronically. In most countries, incident reports must be sent not only to the governing authority but to other members of the medical device supply chain: manufacturers, product representatives, healthcare providers and even users of medical devices, where necessary.

In Central and Eastern European countries the vigilance system on a national level is controlled by the competent national authorities. Local authorities assess the safety of use, efficacy and quality of medical products, implementing surveillance and inspections. Authorities can monitor investigations, involve experts, take samples, enter and inspect premises, impose sanctions if necessary and may take any further action that might be necessary to supplement action by the manufacturer.

The competent authority of a given member state must notify the Commission and other member-state competent authorities of any life-threatening situations resulting from medical device incidents, as well as restricting circulation of devices. State organizations are required to keep databases of incidents for subsequent reporting to the Commission.

The competent authorities in CEE countries provide information received from the manufacturer and notified bodies to EUDAMED, the online Commission database. With mandatory use of the databank, authorities can gain rapid access to information on incidents and vigilance data as well. Currently the database is not publicly accessible, but the Commission plans to expand EUDAMED and extend database access to non-European regulators. Boosting information exchange will increase transparency in the field of medical devices. In turn, this may result in faster identification of potential risks and prevent repetition of incidents.

Special thanks to our summer trainee Kristopher Doodha for his collaboration.


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