The Medical Device Regulation (MDR) is the latest European Union directive that governs how medical devices are produced and distributed in Europe. It was designed to increase the safety, performance, and overall quality of medical devices on the continental market. If you are in the business of creating medical devices, MDR compliance is now legally mandatory since May 2021. MDD compliance is no longer enough, as the MDR introduces brand new requirements as well as modifying previous ones. Read on to learn more about the EU MDR, who it applies to, what kind of devices it covers, what’s new in comparison to the MDD, and tips for achieving compliance!
Medical device regulation in Europe
Until 2021, medical devices in the European market were regulated by the Medical Devices Directive (MDD). First introduced in 1992, the MDD’s purpose was to align laws relating to the production of medical devices in the EU. This directive contains 23 articles and 12 annexes, coming to a total length of 60 pages. With the MDD, each country within the European Union was responsible for devising its own laws to implement the guidance contained in the directive. As a result, there were many inconsistencies and loopholes which some took advantage of, leading to risky products entering the market. In order to protect patients and operators from faulty medical devices, a new directive was needed. That’s why (amongst other reasons) the EU decided to create a much stricter standard known as the EU MDR, or European Union Medical Device Regulation.
What exactly is the EU MDR?
The European Union Medical Device Regulation (EU MDR) is a new directive that has fully superseded its predecessor, the MDD (Medical Devices Directive). Fully applied from May 2021 after some COVID-19 related delays, the MDR is much more complex and detailed compared to the MDD. To give you an idea: compared to the MDD’s 23 articles, 12 annexes, and 60 pages, the MDR boasts 123 articles, 17 annexes, and a whopping 175 plus pages. With that in mind, It’s no wonder that medical device manufacturers are nervous about meeting the requirements of this new directive.
The EU MDR is also a binding legislative act. That means that unlike the MDD’s guidance, which was up to interpretation and individual implementation of EU member states, the EU MDR was designed to be a set of direct regulations which industry players legally have to comply with if they want to bring their products to the European market… and keep them there. Compared to the MDD, the EU MDR focuses more on retaining approval than getting it in the first place. It also puts a higher emphasis on risk management, safety, oversight, and using data, as well as routine maintenance evaluations that are required in order to retain approval.
Who does the EU MDR affect?
It’s important to understand what kind of organization the EU MDR affects as well as who in the organization needs to be concerned with EU MDR compliance. According to the regulation itself, if you are “a manufacturer, authorized representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices” then the EU MDR applies to you and you need to know how to comply with it.
Within the organization, many departments and disciplines are affected as well. While some might think that MDR compliance is limited to QA, compliance, engineering, and manufacturing functions, it’s actually the whole business that is affected by MDR:
- The leadership team needs to ensure compliance by investing in qualified talent, as well as the right processes and procedures
- The finance team needs to figure out the budget in a way that supports compliance
- HR needs to make sure personnel have the right training and qualifications to manage these issues.
All in all, implementing EU MDR in a business relies on all the functions within the organization working together to achieve compliance.
What devices does the EU MDR cover?
It is vital to be aware of which devices fall under the EU MDR in order to know if your organization and product line is affected. This is especially critical now given that the scope of MDR is much bigger than its predecessor the MDD, and even extends to non-medical products. Some examples of non-medical products it extends to are contact lenses and condoms. In addition to that, EU MDR doesn’t distinguish between embedded and standalone software – both are covered in the new regulation.
So without further ado, the MDR defines the term “medical device” as:
“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:”
- Diagnosing, preventing, monitoring, and treating diseases
- Diagnosing, preventing, monitoring, and treating injuries or disabilities
- Investigating, replacing, or modifying part of a person’s anatomy, physiology, or pathological process or state
- Providing in vitro examinations of human specimens like organ, blood, and tissue samples
- Controlling or supporting contraception
- Cleaning, disinfecting, or sterilizing aforementioned devices
Another reason why it’s important to know which type of devices fall under the EU MDR is exemptions. Depending on which kind of medical device you work with, i.e. your device classification, you may be exempt from certain processes.
What’s new in the EU MDR?
Overall, the new EU MDR encourages a product life-cycle approach for the production of medical devices using a comprehensive Quality Management System (QMS). This means that rather than focusing on the pre-approval stage of medical device manufacturing, it focuses on how to retain approval and keep it on the market, while providing the highest quality and safest product for patients and end-users. The shift to a life-cycle approach requires significant changes to the ways organizations have operated on the EU market until now.
In terms of key changes to the contents in comparison to the MDD, here are a few of the ones you should be aware of when it comes to the EU MDR:
- An extended medical device definition scope which now includes software as well as aesthetic products
- Increased requirements in the areas of clinical evidence and technical documentation
- Post-market surveillance requirements that were not present in the MDD
- Increased responsibilities when it comes to economic operators (distributors, importers, etc).
These are just a few examples of the types of new requirements the MDR contains; all of them have a significant impact on how manufacturers produce their medical devices, evaluate them, go to market, and monitor how they do from that moment on. For more information on the exact contents of EU MDR as well as actionable compliance tips, check out our detailed white paper!