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:
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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.
The MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsThe MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsThe digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes 1. Drivers of the digital transformation of notified bodies The period in which notified bodies, as an oligopoly, were allowed to pick and choose customers and determine prices and conditions is coming to an end.…
DetailsThe Medical Device Coordination Group (MDCG) is an expert panel required by the MDR and IVDR. The MDCG is sometimes confused with another coordination group or with expert panels. You can find out how these groups are differentiated here. Read this article to find out how you are affected by the output of the MDCG’s…
DetailsPost-Market Surveillance (PMS) is a proactive and systematic process to derive necessary corrective and preventive actions (CAPA) from information about medical devices already placed on the market. We have created a Post-Market Surveillance checklist for you. With this checklist, you can find out whether you meet the regulatory requirements of the MDR for Post-Market Surveillance…
DetailsCurrently, manufacturers of legacy devices can keep their devices on the market without demonstrating conformity under Regulation 2017/745 on Medical Devices (MDR). However, manufacturers will have to provide the necessary clinical data by the end of the transition period at the latest. The requirements for clinical data that can be used to demonstrate conformity have increased enormously under the MDR. Furthermore,…
DetailsBoth 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…
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