Different rules for homemade medical devices
If you produce medical devices in your care facility, the rules that apply to you are less strict than those for regular manufacturers. You have to meet the new conditions for medical devices produced and used in care institutions. You will find these conditions in article 5 of the MDR and IVDR. For example: you have to draw up a declaration that there is no equivalent alternative on the market. If you fail to meet these conditions, the stricter rules for manufacturers apply to you.
These rules also apply when you produce software, like medical apps.
Inform your patients if there is a problem
All medical devices must carry a unique device identifier (UDI). When a patient uses a medical device with this unique barcode, it is immediately clear to everyone which one it is. You must keep a register of all UDIs issued for high-risk implants. That way, you can easily track a patient who uses a certain type of implant.
The MDR does not prescribe how to register the UDIs. The National Implant Register Act (Wet Landelijk Implantaten Register, LIR) does. The LIR (in Dutch) states that you have to save the UDI information in the patient file and in the National Implant Register. Failure to do so may result in a fine.
New implant rules
Under the new regulations, you have to provide more implant data to the National Implant Register. The overview of implants that have to be registered in the LIR (the inclusion list, in Dutch) has been extended to all implantable devices (class III implants), with a few exceptions.
Give your patients the implant card
All implants come with an implant card, issued by the manufacturer. You must give this implant card to your patient. Put the patient’s data on the card first. Other information on the implant card is:
- the implant data, including the UDI;
- the manufacturer’s data.
Patients must have access to additional information about the implant. For instance on the manufacturer’s website, or on the personal health portal.
National Implant Register (LIR)
The National Implant Register Act states that you have to provide data on certain implants in a client’s medical file. You provide these data to the LIR, see this factsheet (in Dutch).
Gather information in the EUDAMED databank
EUDAMED is the European database for information on medical devices and manufacturers. You will have access to the same public parts of EUDAMED as patients. This might prove helpful if you are trying to gather information on medical devices in the purchasing process. EUDAMED has not been released for public access yet. It is expected to come into service in May 2022.
Tell manufacturers about your experiences
As care provider or institute, you have to inform manufacturers of your experiences with medical devices. They in turn have to conduct post-market surveillance.
Do you need help implementing the new in vitro diagnostics regulation? Ask your umbrella organisation what it can do to assist you.
In vitro diagnostics may be in shorter supply
Because of the stricter regulations, some in vitro diagnostics may not be readily available after the transition. If you purchase or use in vitro diagnostics, you would do well to start talks with your suppliers in time to find out if the availability of the products you need will be affected, or even stopped; for instance because the manufacturer has to start using different materials for their production.
In some cases, there will be a transition period during which previously marketed products may still be sold and bought.
Other consequences of the new medical devices regulation
The new MDR and IVDR have more consequences for you:
- the prerequisites for care institutes producing medical devices have changed;
- the demands for clinical research have become stricter;
- new rules have come into effect for re-processing single-use medical devices and cosmetic devices.