The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve patient safety and strengthen regulatory supervision. It wouldn’t be far-fetched to say that the regulation had a significant effect on medical device manufacturers and markets around the world.
Now that the EU MDR is in place, medical device makers have to adhere to more strict requirements and undergo a much more complex regulatory process. In this article, we will look at a targeted approach to EU MDR, focusing on the basic and most important factors that EU MDR manufacturers have to know about in order to successfully tread the regulatory framework.
What is the EU MDR
So, what is the EU MDR, and why is everyone so hung up about it?
Well, the EU MDR regulation, or the Medical Device Regulation 2017/745, is a regulation that controls the entire process of medical devices and associated device manufacturing.
The EU MDR has control over almost everything medical device companies do. From their research to actually device manufacturing to quality management systems to placing the medical device in the market.
The EU MDR came into effect in May 2021, replacing the Medical Device Directive (MDD) and establishing harsher rules for European medical device producers. Since then, the regulation has been added to many other smaller declarations and guidance documents. The goal of the regulation was to promote medical device transparency, traceability, and patient safety throughout their lifespan.
One of the major differences between MDR and MDD is the more specific classification rules of the devices. The classification made manufacturing both easier and harder. On one side, now all regulations are based on which class the device is, so it’s easier to distinguish in between various requirements. On the other hand, higher-class devices have to jump through more hoops to get certified.
The EU MDR classifies medical devices into four categories based on their potential harm to patients. To get the conformity assessment mark, or CE mark as we like to call it, manufacturers must ensure proper categorization of their devices. Class I devices are the least harmful to the human body, while Class III devices are the most dangerous. Higher class devices have to get approval from a Notified Body: another thing the MDR added. There are also IVDs, or in vitro medical devices, which are regulated via the IVDR.
So, how do you prove that your device and the process that you have gone through comply with the MDR requirements? Well, you show the documents to prove it!
Compliance with the EU MDR involves submitting a considerable number of technical documents demonstrating the safety and performance of your medical devices. This paperwork should include an exhaustive overview of the device, its intended function, clinical evaluation, risk management, and plans for post-market surveillance. Moreover, it is extremely important to build a strong Quality Management System (QMS) that is in accordance with the norms and standards of the legislation.
Clinical Data (Clinical Evidence, Post-Market Surveillance, and others)
Conducting meticulous clinical investigations to determine the safety and performance of medical devices is an essential component of EU MDR compliance. To show that their device works in accordance with its intended use and is safe, manufacturers must collect clinical evidence, including clinical studies and post-market surveillance data. Not to mention, they have to go through the existing studies supporting and against their medical device technology and create a systematic literature review. Furthermore, the EU MDR puts a great emphasis on proactive post-market monitoring to monitor device performance, detect adverse events, and ensure continued safety and efficacy.
Unique Device Identification (UDI)
Another new concept the EU MDR introduced is the unique identifier (UDI). This system increases traceability and post-market safety monitoring of individual medical devices. From now on, manufacturers must issue one unique identification number to each medical device they produce and enter that data in a UDI database. This allows for more efficient product recalls, more supply chain transparency, and easier reporting of adverse events. Ideally, you can use just the device number to locate the device.
Manufacturers have to know their supply chain and verify that their suppliers and subcontractors meet EU MDR criteria. You have to develop strong partnerships and quality agreements with suppliers in order to keep control over the whole production process and guarantee the end product’s quality and safety. After all, the MDR requirements are there to ensure quality. If the medical devices’ quality is not up to the state of the art, then it is all for nothing.
Getting approved by the Notified Body is required for all higher-risk medical devices. Notified Bodies are independent bodies (or professional organizations) appointed by EU member states to evaluate medical device compliance with the EU MDR. Before you can get a conformity certification for your products, you have to pick and apply for a Notified Body based on its experience, capability, and designation scope.
The implementation of the EU MDR includes a transition period to allow manufacturers to adjust to the new regulations and transfer from MDD (the previous system). However, to avoid non-compliance, it is important to start right away. You will have to do a lot of work in a short amount of time, meet deadlines, and maintain market access.
The EU has a lot of manufacturers trying to place their devices in the competitive market. This huge number has created some blockage in the system. Plus, some manufacturers are still working to get their CER ready. So, the EU decided to put in an extension to the transition period to help smoothen the process.
What is EU MDR vs. FDA?
The EU MDR stands for the European Medical Device Regulation. The regulation controls the manufacture and distribution of medical devices sold in the EU.
The FDA stands for the Food and Drug Administration. It controls the production and distribution of several products, including medical devices, in the USA.
Is EU MDR replacing the current MDD?
Yes. The MDR replaced the MDD.
What is the MDR regulation in Europe?
This regulation controls the manufacture and distribution of medical devices across the EU and ensures the best device quality and safety.