Clinical evaluation: you can easily avoid these misconceptions and mistakes
This article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them.
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.
ISO 10993-17: What the standard has changed and now requires from manufacturers
The 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.
DetailsThe Clinical Evaluation Plan
Including 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…
DetailsSBOM: Software Bill of Materials
Laws 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.
DetailsGLP – Good Laboratory Practice
GLP (Good Laboratory Practice) defines requirements for a quality assurance system for non-clinical health and environmental safety tests. It also describes the organizational procedure and conditions under which laboratory tests are planned, carried out, and monitored. GLP also covers the record and reporting of. In this article, you can read which requirements medical device manufacturers…
DetailsIT security for legacy devices
Understandably, 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…
DetailsWhat manufacturers need to know about legacy devices
Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…
DetailsRisk management plan: The most important advantages
The risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article
DetailsPost-Market Clinical Follow-up: Best Practices for PMCF
How to meet PMCF regulatory requirements as quickly as possible Post-Market Clinical Follow-up is increasingly being criticized by the notified bodies. And this is after the manufacturers have successfully mastered the hurdle before: the initial clinical evaluation. This article provides manufacturers of medical devices with
DetailsWhen can clinical studies be avoided for devices with artificial intelligence?
For manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
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