DAkkS: The German Accreditation Body
The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
Declaration of Interest
A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence. This article is about declarations of interest in a clinical context.
DetailsArtificial intelligence in medicine
More and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
Closed-loop systems in medical devices
Medical devices are increasingly based on closed-loop systems. These “closed-loop systems” are already mentioned in the Medical Device Regulation (MDR). One example is a system consisting of an insulin pump controlled by a device with a glucose sensor. In this article, you will learn what closed-loop systems are, where they are used in medicine, and what…
DetailsSupplier evaluation – supplier selection – supplier audits
The MDR and IVDR, as well as ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection, and supplier monitoring. This article not only gives you an overview of the regulatory requirements. It also gives you tips on how to implement them and tells you when a supplier audit is necessary.
DetailsMedicinal product or (substance-based) medical device?
The classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences. This classification is so demanding that there are regular disputes with authorities and notified bodies, and in 2023, even the European Court of Justice had to rule on the matter. This article helps manufacturers, authorities, and…
DetailsImporters: What do the MDR and IVDR actually demand?
The EU regulations the MDR and IVDR set out precise requirements for importers. And they also define who is an importer. Bringing a device into the EU does not always constitute an import. And, furthermore, companies that import medical devices don’t just have to meet the requirements established for importers.
DetailsRisk-Based Approach
Many authorities and regulations refer to a risk-based approach (RBA) but do not define the term or provide examples. This article provides an overview of how risk management and ISO 13485 interact and what a risk-based approach is and gives specific advice on how
DetailsDistributor requirements (that also affect the manufacturers)
The Medical Device Regulation (MDR) has significantly increased the requirements for distributors. Learn to understand these requirements to avoid multi-year custodial sentences threatened in the event of infringement. This article also considers extensive guidance issued by the Irish regulator.
DetailsMaintenance and service of medical devices
The terms maintenance, preventive maintenance, restoration, inspection, service, and safety inspections are not synonymous. But they all refer to activities in the life cycle of medical devices that serve the objective of ensuring the safety, performance, and effectiveness of these devices even after they have been placed on the market. Manufacturers and operators must meet…
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