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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Neither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devices. However, manufacturers should be aware that a lot of legal regulations entitle injured persons to claim compensation if a defective medical device causes harm to a patient, user, or third party. Liability may result, for example,…
DetailsAnytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will give you answers and present the seven steps to quickly place your devices on the market in compliance with the law.
DetailsSwitzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland. However, since May 26, 2021 (for medical devices) and May 26, 2022 (for in vitro diagnostic devices | IVD medical devices), manufacturers from Switzerland as well as manufacturers from other markets (e.g., the EU)…
DetailsBrexit was completed in January 2021. What was a cause for celebration for some means an additional burden for many – including medical device manufacturers. For manufacturers, it is important to understand which regulatory requirements they will have to fulfill and which transition periods they will benefit from if they want to continue selling their…
DetailsPeople often talk about the approval of medical devices, even if something else is meant – sometimes a certificate of conformity, sometimes a “clearance,” sometimes a successfully completed conformity assessment procedure. Terms like “MDR approval” are even misleading. This article clarifies what a medical device approval means and when manufacturers need one in the first…
DetailsA lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
DetailsManufacturers of medical devices, as well as manufacturers in all other life science sectors, such as the pharmaceutical industry, are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures. Keeping track of…
DetailsMedical device and IVD manufacturers must distinguish the concepts of “abnormal use,” “foreseeable misuse,” “errors in normal use,” and “misuse.” This is a prerequisite for understanding and complying with ISO 14971 and IEC 62366 requirements. Even the measures that manufacturers must take depend on the type of use.
DetailsThe Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should place their class 1 medical devices on the market in order to comply with the MDR. The title of the document is “Guidance Notes for Manufacturers of Class I Medical Devices”. This article provides a summary of the document and gives…
DetailsChemical characterization according to ISO 10993-18 is a central component of the biocompatibility evaluation according to ISO 10993-1 and, thus, a prerequisite for the approval of medical devices. It is used to identify unknown substances in medical devices to carry out a toxicological risk assessment. This article provides an overview of
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