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.
In Article 120, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs. A flow chart in chapter 2 of this article…
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…
DetailsClinical affairs managers play an essential role in demonstrating the safety, performance, and benefits of a medical device. They operate at the interface between science and regulation. This article sheds light on the multifaceted role of these experts: tasks and challenges, as well as earning and career opportunities. 1. Tasks of clinical affairs managers Clinical…
DetailsPDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides 1. PMDS: Functionalities and requirements Patient data management systems (PDMS)…
DetailsThis article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them. The five most common misconceptions Misconception 1: A class I device does not require a clinical evaluation This is wrong. All medical devices must meet the essential requirements of the MDR (formerly…
DetailsThe ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help. 1. Context of ISO 10993-17 1.1 The…
DetailsIncluding a free download of the chapter structure for the Clinical Evaluation Plan The Clinical Evaluation Plan is one of the most complex documents in the technical documentation. Alongside the Clinical Evaluation Report, the Clinical Evaluation Plan (CEP) is the document most frequently criticized by notified bodies. Even experienced clinical experts typically need 60 working…
DetailsManufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…
DetailsLaws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons. 1.…
DetailsUnderstandably, laws and standards also require IT security for legacy devices. However, the way in which these requirements are formulated often leads to confusion. For example, legislators and standard committees have been unable to agree on common definitions. One definition refers to the IT security of legacy devices, another to the IT security of old…
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