The Medical Device Regulation (MDR) is an EU regulation that manufacturers who wish to place medical devices on the market in the EU must comply with. It also affects distributors and importers of these devices as well as notified bodies.
Regulation (EU) 2017/745 on medical devices, which is the official title of the MDR, came into force in 2017 and applies since May 26, 2021.
The Medical Device Regulation has been amended several times. You can find the consolidated version of the MDR in German and in English. These also contain the transitional periods that were extended in March 2023.
Manufacturers of in vitro diagnostics should read the article on the IVDR.
This article on the MDR provides you with an initial overview of the Medical Device Regulation. The video linked therein presents the EU Medical Device Regulation in just a few minutes. You will also find:
If you are not a medical device manufacturer, you should start with these pages:
At the bottom of this keyword article, you will find all other articles on the MDR.
Do you still have questions about the MDR and its implementation? You can get answers in our free micro-consulting.
Download the free starter kit. It gives you an overview of the regulatory landscape and shows you the 6 steps to “approval” of your medical device. It also contains the MDR checklist as a PDF and in DOCX format!
The video training courses at our Medical Device University show you step-by-step how to create your technical documentation and QM system in a lean, fast, and MDR-compliant way. Over 100 templates and sample documents are available for download.
In this way, you create the prerequisites for approving your devices quickly and safely and launching them on the market.
The experts at the Johner Institute can help you verify and validate your devices:
Benefit from the know-how of our regulatory affairs experts to
Contact us immediately so we can clarify together how you can quickly and efficiently meet the regulatory requirements of the MDR and bring your devices safely to market.
Both European and U.S. regulations place requirements on the labeling. However, the two legal systems do not understand the term entirely identically. Even the spelling differs: labeling in the USA, labelling in Europe. In this article, you will learn what you need to keep in mind in each case when it comes to labeling. Speaking…
DetailsThe European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid. 1.…
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.