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 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.
DetailsThe 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…
DetailsThe 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.
DetailsMany 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
DetailsThe 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.
DetailsThe 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…
DetailsMedical writers have a firm place in the ecosystem of medical device and IVD manufacturers. This article clarifies
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…
DetailsThe “design verification” requirement is not just a requirement of the FDA. This article describes what “design verification” means and which regulatory requirements medical device manufacturers should fulfill.
The EU’s in vitro diagnostic medical device regulation (IVDR) affects many medical laboratories, although the regulation does not define or use the term “medical laboratory.” Which laboratories are affected? What other laws do the laboratories have to comply with? And how should they ensure compliance with all these requirements? This article provides answers.
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