Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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The Machinery Directive (2006/42/EC) is generally applicable to machines of all types. However, the directive can also be relevant for medical device manufacturers: both the MDR and the IVDR refer to it. If the Machinery Directive comes into play, requirements that go beyond those of the MDR and IVDR apply. Therefore, this article will give you an…
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…
DetailsISO 20417:2021 Medical devices – Information to be supplied by the manufacturer establishes requirements for the general information that manufacturers have to supply with their medical devices and IVD devices. The authors have succeeded in presenting the criteria in a clear and comprehensible manner. ISO 20417:2021 is also on the list of standards to be…
DetailsIEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic safety. The article also addresses the IEC 60601-1/AMD1/ISH1:2021 INTERPRETATION SHEET 1.
DetailsManufacturers of substance-based medical devices such as seawater nasal sprays, mucous membrane-soothing cough syrups, or osmotically active laxatives face several challenges once the Regulation (EU) 2017/745 (MDR) came into force: This article illustrates what can be done to overcome the regulatory hurdles and ensure the marketability of your substance-based medical devices beyond the transition periods.…
DetailsIVD medical device validation confirms the device’s medical purpose. IVD medical device verification, on the other hand, proves whether the IVD works as intended. In this article, we provide a five-step guide on how to carry out the verification and validation of your IVD medical devices in a targeted manner and without unnecessary effort. We…
DetailsWhen ANVISA registration is no longer sufficient As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device. Manufacturers should be aware of the cases in which they must…
DetailsIf you have to conduct a clinical investigation for your medical device or clinical performance study for your IVD, you won’t be able to avoid sample size planning. And you will need to avoid the following two problems when calculating the sample size: Therefore, you need to accurately identify the exact sample size needed so…
DetailsThe same legal requirements apply to the clinical evaluation of software as to the clinical evaluation of all medical devices. This means that as a Medical Device Software (MDSW) manufacturer, you must prepare a clinical evaluation for your product just like any other manufacturer. A performance evaluation must be carried out for software that is an in vitro diagnostic…
DetailsA Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…
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