The Medical Device Regulation (MDR) is the latest European Union directive that governs how medical devices are produced and distributed in Europe. It has been legally mandatory since May 2021, for any business that is creating medical devices and wants to distribute them in Europe. This regulation was designed to increase medical devices' safety, performance, and overall quality. The EU MDR introduces new requirements as well as modifies previous ones. Read on to find out what changes it has brought to the table for MedTech companies.
Before the EU MDR medical devices in the European market were controlled by the Medical Devices Directive (MDD). When it was first introduced, its purpose was to align laws relating to the production of medical devices in the EU. This previous regulation had many inconsistencies since each country within the European Union was responsible for devising its own laws to implement the guidance contained in the directive. Therefore, the EU MDR was created, to have a cohesive, strict regulation for medical devices in the EU. The EU MDR includes a new EU database (EUDAMED) for medical devices to which the public will have full access.
What’s new in the EU MDR?
Overall, this new regulation encourages a product life-cycle approach for the production of medical devices using a comprehensive Quality Management System. So, 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 at the same time providing the highest quality and safest product for patients and end-users.
Knowing which devices fall under the EU MDR is important to know if your organization and product line is affected. Given that this new regulation extends to non-medical products it covers both embedded and standalone software. Furthermore, it is important to know which types of devices fall under the EU MDR exemption list. Depending on which type of medical device you work with, i.e., your device classification, you may be exempt from certain processes.
The changes brought on by this new regulation are wide-range and present manufacturers with significant challenges- but also opportunities when it comes to ensuring the integrity of product development.
As stated previously, the EU MDR focuses heavily on risk reduction in the development and marketing of medical devices. Article 10,2 of the regulation requires manufacturers to establish, document, implement and maintain a product safety risk management system. In summary, you need to reduce any risk associated with the device as much as possible.
With the EU MDR new classification rules have been implemented that change how certain types of devices are scrutinized and now capture certain devices within the requirements that were previously not included. These include certain products for aesthetic procedures such as injectable fillers, and liposuction equipment just to name a few.
Also, this Medical Device Regulation now includes special rules for software (that could be used in clinical observation) to provide diagnosis, active implantable devices, and others.
Notified Bodies (NBs) are conformity assessment bodies (e.g. BSI, TÜV SÜD, etc.), which offer medical device companies a review of all aspects of their product development and quality processes, including the final product itself, to ensure compliance with EU MDR requirements, and to maximize patient safety.
The EU MDR has required NBs to re-apply for designation and they will be subject to increased oversight going forward. This requirement has caused capacity issues within the system, which resulted in some manufacturers rationalizing their product ranges where the cost of achieving compliance makes retaining them uneconomic.
For more information on the exact contents of this new regulation and the best approaches to the EU MDR download our free white paper!