The European Medical Device Regulation (MDR) is an extremely daunting set of rules for medical devices within the European Union. The MDR comprises more than 100 articles, making it virtually impossible for any person responsible for creating medical devices to simultaneously be an expert on the regulations enforced upon them. Understanding the ins and outs of the MDR is a full-time job in itself, so you can’t be expected to know each and every one of the articles and their specific details. But don’t worry, as an expert in language solutions in the medical device industry, United Language Group is here to guide you through it each step of the way.
Navigating the MDR: Categories of Regulation
Because the MDR is so long and complex, containing 123 articles, it can be beneficial to group categories of regulated activities together. For example, many articles within the MDR deal with the labeling of medical devices. Labeling can be considered a category where many separate articles can be grouped together for convenience and ease of understanding.
General manufacturing is another category we can use when examining the articles of the MDR. Steps such as importing and exporting are included under this umbrella. A device manufactured in the United States that will be brought to and used in Europe must comply with the standards of European MDR.
How can the articles of the MDR be organized to make them easier to understand?
While the official structure of the MDR makes it difficult to identify all the rules that apply to any given activity, our previous MDR webinars and e-book contain in-depth analyses of the MDR. They group the regulations’ various articles into the following categories:
- Articles related to labeling
- Articles related to general manufacturing of medical devices
- Articles related to different types of medical devices
Over the course of the next few weeks, ULG will be publishing articles to our blog that take a deep dive into specific categories of regulation within the MDR. These articles are aimed to help device manufacturers gain a broad understanding of the MDR and create a single resource for everything MDR related, so they can focus on developing medical devices rather than having to become an expert on the MDR rules themselves.
ULG also hosted a 3-part webinar series on the MDR in January and February. Additionally, ULG will be hosting a follow-up Q&A-style MDR webinar with MDR expert Ronald Boumans. You can request access to the 3-part series here.