Challenges posed by the MDR legislation and EUDAMED

How is new legislation affecting hospitals?

From the 1st of January 2020, every hospital in the Netherlands is responsible for registering the product data of every implant used in an operation. The implant data needs to be put in the Electronic Patient File and needs to be sent to the National Register of Implants (LIR / Landelijk Implantaten Register). The patient must then also be given a so called ‘implant card’ which contains all the necessary product information. Those are just some of the consequences of the Dutch Wkkgz-law (Quality, Complaints and Health Care Disputes Act) that came into effect earlier. On the European level, similar legislation will take effect on May 26th 2020. We call this Implant Register the EUDAMED: the European database on medical devices.

These kind of organizational changes will require a lot of resources from hospitals. Accessing the right product information means hospitals need to start working with GDSN data pools and that product information needs to meet GS1 data standards. It’s a entirely new but very important process. How this exactly works is one of the topics we cover in our ‘webinar: ‘Working with GDSN data, GS1 standards and MDR’.

The purpose of the National Implant Register is to increase patient safety which comes at no surprise if you think about just some incidents in recent years that have had a major impact on public health. The most well-known example are the problems happening with leaking breast prostheses, but there were also irregularities with stents and pelvic floor mats. In order to be able to inform patients in time of any complications, the implant registration has been created.

To ensure that the registers and databases are always completely correct and up-to-date, healthcare providers or healthcare institutions – that is to say hospitals and private clinics – are now legally obliged to register this data and submit it to the national implant register.

So how does the process work?

A patient goes to a hospital or clinic for surgery. The doctor uses an implant. Whoever does the administration – whether it’s the doctor, an assistant,  nurse or administrator – registers the implant in the patient file. By transmitting the data on the implant registered in the patient file via a link, the care provider ensures that the implant is added to the National Implant Register and – if necessary – can be linked to the patient. If something is wrong, the hospital or clinic can contact the patient quickly. And patients can now be helped even faster.

What does this mean for your hospital?

What should you do with this as a hospital? How can you act quickly and appropriately? View our webinar and find out immediately how you as a hospital can respond quickly to this legislation.