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Since 26 May 2021, the European Union’s Medical Device Regulation (MDR) is fully applicable, replacing the Medical Device Directives which have been around for almost three decades. The ideal moment for a deep dive into official regulations for medical products, how they work, and what this MDR means. For you as a user of medical devices, but also for us as your manufacturer.
Healthcare and technology have gone hand in hand for centuries. Prostheses are as old as time, microscopes have been around since the 1600s, and the 19th century saw the introduction of the stethoscope and x-ray images. Looking at more recent times, we could write a volume as thick as your high-school dictionary about the advent of the internet and its impact on healthcare, but we’ll spare you of that.
Still, going digital is one of the most steady and impactful evolutions that happened during the last decades in healthcare. And that brings along both opportunities and challenges.
Today, we’re at a turning point. Many medical organizations have embraced innovations such as electronic records and administration, digital operating rooms and radiology through medical displays.
On the other hand, a second wave of technological innovation is coming up quickly, with artificial intelligence, blockchain, voice search, and virtual reality being some hot terms that raise lots of heated discussions today. These are counted on to streamline operations even further, reduce costs, and offer better and more personalized care – both physical and mental.
Many governments have installed regulatory frameworks for medical products. Their reasons for doing this can be boiled down to the following two:
Two of the best-known authorities regulating medical devices are the American Food and Drug Administration (FDA) and the European Commission (EC). Their regulations often serve as standards for other countries. This last one, the European Commission, is now applying a thorough revision of its existing legislation regarding medical devices. Let’s take a look at what that means!
For the last 25 years, Europe’s medical devices market has been regulated by the Medical Device Directives (MDD). Even though they have been updated a few times to stay in tune with new developments, they have now been replaced by a new Medical Device Regulation (MDR). Here are some short takeaways about the MDR:
Safety runs like a thread through the EU’s Medical Device Regulation. Of course, a medical device must be physically safe: it cannot be toxic or dangerous – or this must at least be known to those getting into contact with it.
With medical devices getting connected and software solutions being developed and used for medical use, ‘security’ has become an increasingly important term to consider as well. Security refers to protecting data that is stored, ensuring patients’ and employees’ privacy rights. For example, systems collecting personal information should already be complying with the General Data Protection Regulation (GDPR). In addition to this, the MDR states that cybersecurity should be taken into account from early development of a device and throughout its entire lifecycle. It cannot be stated enough that connected medical devices must be digitally secure.
Good point, dear reader. All Barco medical products have been certified and comply with the new MDR.
Our radiology displays, QAWeb Enterprise and Intuitive Workflow Tools are already MDR-certified as Class IIa, in line with the MDR’s rule 10. Their product information has been reviewed and cleared by independent medical and technical experts and is audited yearly. In other words, we ensure diagnostic confidence and peace of mind for our users.
In case you have any question, don’t hesitate to reach out to us 😉.