What exactly is a medical device?
You've probably heard it mentioned before: a medical device. But what exactly does it include? Well, that's quite a broad term. Think instruments, devices, software, implants, or even medical device cleaners. As long as something is intended to help diagnose, treat, prevent or support disease or disability, it quickly falls into this category.
A plaster, wheelchair, heart valve or even an app that can predict disease - these are all examples. It all revolves around what it is intended for, or the ‘intended use’ according to the manufacturer. This is usually on the label, in the manual or in advertising.
What has changed because of the MDR?
Since 2021, European regulations around medical devices have been tightened with the MDR (Medical Device Regulation). This means stricter rules for manufacturers and healthcare providers. For example, manufacturers must now provide more evidence that their devices are safe and effective, especially if they fall into a higher risk class.
In addition, the term ‘medical device’ has been expanded. For instance, apps that predict disease based on DNA information are now also covered by the MDR.
What does this mean for healthcare providers?
For healthcare organisations, it mainly means extra attention when selecting and purchasing devices. You want to be sure that everything meets the MDR requirements and that the product is a good fit for what you need. And yes, that CE mark is still important in this respect.
Furthermore, the MDR calls for better monitoring of devices, even after they are already in use. This is called post-market surveillance (PMS). In short: manufacturers should continue to check whether their products work properly and are safe, even after they have been put on the market. To do this, they often need information from healthcare providers. So if you notice something during use, it's a good idea to report it. This is how manufacturers and healthcare providers work together on the safety and quality of devices.
Crafting yourself? Beware!
Some healthcare providers make their own devices, for example special braces or software for patient care. This is still allowed, but only if there is no comparable product for sale. And even then, the device must meet the safety requirements of the MDR. You have to document it well and keep track of how it works. Should something go wrong, you must be able to explain it.
What if something goes wrong?
Suppose something goes wrong with a device. Then it is important to report it to the manufacturer immediately. You are also obliged to report serious incidents to the Healthcare Inspectorate. This way, you help to solve problems quickly and prevent risks to others.
The role of manufacturers
Manufacturers have been given additional obligations with the MDR. They must appoint someone to monitor compliance and have a proper plan for post-market surveillance. They must collect data on how their devices perform in practice and take action on it when necessary.
In addition, all devices are given a Unique Identification Code (UDI). This helps with product retrieval and traceability, for example in the event of a recall.
Good to know: there is a European database, EUDAMED, where you can find information on approved devices. Useful if you want to know whether a product complies with the MDR.
In conclusion
So the MDR brings quite a few changes. It requires healthcare providers to be more conscious about the selection, procurement and use of medical devices. But in the end, the goal is clear: to ensure safe, reliable devices that both healthcare providers and clients can rely on.
