In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
DetailsThe MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsThe Health Insurance Portability and Accountability Act (HIPAA) is a US law that establishes requirements for processing protected health data. Institutions that collect or process these data in the USA and their subcontractors must comply with HIPAA if they want to avoid sanctions. For European companies in particular, HIPAA is a regulation that is difficult to understand…
DetailsWe have known how vulnerable IT security is in the healthcare sector since February 2016, when the IT infrastructures of many clinics were brought to a standstill by a simple virus attack. As a result, the authorities are paying closer attention to ensuring that not only clinics but also manufacturers guarantee the IT security of…
DetailsThe regulations relevant to usability engineering require formative evaluations.
The MDR and IVDR require either a “Post-Market Surveillance Report” or a “Periodic Safety Update Report” from medical device manufacturers. The Periodic Safety Update Report is abbreviated as “PSUR”, the Post-Market Surveillance reports as “PMS report”.
DetailsThe MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsBoth IEC 62304 and the FDA require integration tests.
The digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes
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