What do MDR & LIR legislations mean for hospitals, healthcare institutions, and manufacturers?

The main differences between MDR and LIR

The MDR and LIR legislations surely will be no stranger to you. But what do they mean, and what are their differences? The MDR (Medical Device Regulation) is European legislation and covers all classes of medical devices. The National Implant Register (LIR) is Dutch legislation and only covers implants. If you are a manufacturer, healthcare institution, or hospital in the Netherlands, you must comply with both legislations. Different provisions apply depending on the position you occupy. Attention! As a hospital, you can also be a manufacturer if, for example, you manufacture your own medical devices using a 3D printer.

What do the MDR and LIR legislations mean for a hospital, or a healthcare institution?

As of January 1, 2020, every hospital in the Netherlands is responsible for registering the product data of every implant used in surgery. The implant data must be entered into the electronic patient dossier (EPD) and sent to the National Implant Register (Dutch abbreviation: LIR). This must be done automatically via a link to the EPD, or manually via a web portal. SRC-PIM can be used in both cases.

The patient must therefore be provided with a so-called ‘implant card’, a printed paper containing all the necessary product information. These are just a few of the consequences of the Dutch Wkkgz (Quality, Complaints, and Care Disputes Act), of which the LIR is a part.

So what data do you need to register as a hospital or healthcare institution?

In the EPD:To the patiënt:To the LIR:
Manufacturer’s nameProduct nameProduct typeSerial or lot numberDate of implantationIf applicable: date of implant removalManufacturer’s nameProduct nameProduct typeSerial or lot numberDate of implantationHealthcare provider designation (location)Product Type & Product NameManufacturer’s designationUnique designation (UDI)Lot number (batch) & Serial numberDate of implantationIf applicable: date of removal or date of death of the patient

And how do you get all this product data in the right place, all the time?

This kind of organizational change requires a lot of effort from hospitals and healthcare institutions. Gaining access to the right product information will mean that hospitals will have to work with GDSN data pools and that product information delivered by manufacturers must comply with the GS1 data standards. For these organizations, this is an entirely new but very important process. How all of this exactly works is what we covered in our webinar: Working with GDSN data, GS1 standards, and MDR. Watch it here.

On a European level, similar legislation to LIR will enter into force on 26 May 2021. The product data will have to end up in the European database, called EUDAMED: European Database on Medical Devices.

What is less known is that hospitals are not only customers but will also be considered manufacturers under the MDR when they produce medical devices themselves, for example with a 3D printer.

In that context, they will also have to publish product data under certain conditions (by Article 5 of the MDR and IVDR), just as other manufacturers have to. Publication of such product data can take place from SRC-PIM as well. So with SRC-PIM you can not only receive but also publish product data.

What do the MDR and LIR legislations mean for a manufacturer?

To increase patient safety, implants should be easily detectable after surgery. Therefore, LIR legislation aims to ensure the traceability of an implant to a patient should the patient need this information.

That’s why manufacturers are required to provide their medical devices with a uniform identification code and to send these product data to the LIR. Thanks to the identification code and the associated product data, hospitals and healthcare facilities can have all the correct data at their disposal and also put it in the EPD, send it to the LIR, and communicate it to the patient. SRC-PIM lets your own ERP talk to the GS1 data pool to which your product data has to be sent. This way, your item data will not be sent to GS1 until it has been checked, validated, and approved. That’s what we call the First Time Right principle.

Which implants are we talking about?
To get a complete overview of the inclusion list of implants affected by LIR, which need to be entered in your ERP when you’re using them, please have a look at the website of Nictiz (Dutch).

The MDR requires manufacturers to place an UDI (identification code) on all packaging of medical devices (and in vitro diagnostic medical devices) and sometimes also on the medical device itself. In addition, manufacturers are obliged to provide the medical product data in Eudamed, the central European database, and assigning a Basic UDI-DI is required to identify a product family. For this purpose, GS1 has the standard GMN (Global Model Number) available. As of May 26, 2021, the legislation applies to all Class III medical devices.

Receiving and publishing product data via the GDSN-network 
So is your organization behind on getting your product data in order? Or do you not yet comply with the obligation to receive or send product data via GDSN, for example, if you, as a hospital, also produce medical devices yourself using a 3D printer?

Then we have a unique offer for you. Book our free workshop now, which normally costs € 1.879 and discover how to get your medical device item data in order. Get in touch with us via sales@src.nl or click through below this blog.  

After a session with our expert, we will provide you with extensive advice and a clear plan of action tailored to your organization. So you can get off to a good start right away!

Want to learn more? Read our other blogs on this topic: