Medical Writer: What this role must accomplish
Medical writers have a firm place in the ecosystem of medical device and IVD manufacturers. This article clarifies
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.
Tip
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.
Gaining an insight into the Medical Device Regulation
Medical device manufacturers
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:
- the most relevant requirements of the MDR
- the structure of the regulation
- further information, e.g., on the transitional periods
Other stakeholders
If you are not a medical device manufacturer, you should start with these pages:
- Requirements for distributors
- Requirements for importers
- Information for hospitals and other operators
- Requirements for manufacturers of specific devices without an intended medical purpose (Annex XVI devices)
At the bottom of this keyword article, you will find all other articles on the MDR.
Support with the implementation of the MDR
a) Free offers
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!
b) Videos and e-learning
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.
c) Verification and validation
The experts at the Johner Institute can help you verify and validate your devices:
- Usability tests
- Penetration tests
- Electrical safety and EMC tests
- Biocompatibility tests
- Clinical evaluations and reviews
d) Consulting
Benefit from the know-how of our regulatory affairs experts to
- determine your regulatory strategy and classify devices,
- create technical documentation (TD),
- set up QM systems (QMS),
- review TD and QMS and prepare for and accompany audits and reviews, and
- simplify post-market surveillance.
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.
Clinical validation: A definition
The term “clinical validation” is also frequently used in the context of medical devices. For example, the German Federal Ministry of Education and Research (BMBF) has published a guideline on the clinical validation of innovative medical technology solutions (only available in German). The FDA also refers to clinical validation. What is clinical validation? What distinguishes…
DetailsClinical investigations of medical devices under the MDR – The regulatory pathway
The requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here.
MDR transition periods
In Article 120-123, 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…
DetailsLaboratory products for “Research Use Only” (RUO) – often a dangerous claim
Manufactures 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…
DetailsOrphan medical devices: Hope for the weakest?
Orphan medical devices are medical devices (and IVDs) for small patient groups. The development of these niche products is often not profitable for manufacturers. As a result, particularly vulnerable groups, such as children, do not always receive adequate medical care. This article shows possible solutions and classifies the guideline MDCG 2024-10.
DetailsSSCP – Avoid redundant work on the “Summary of Safety and Clinical Performance”
The SSCP (Summary of Safety and Clinical Performance) is not the only report that the MDR requires from many medical device manufacturers. In terms of content, the SSCP even overlaps with the PSUR and the PMS reports. The IVDR places almost identical requirements on the SSP (Summary of Safety and Performance). How do all these…
DetailsInstructions for use for medical devices and IVDs in the EU
Poor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use. This article will…
DetailsSystems and procedure packs
The 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.
DetailsClinical affairs manager in the medical device industry
Clinical 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.
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