NIS-2 on cybersecurity: It’s probably affecting you!

The NIS-2 (Network and Information Security) Directive is a European directive (Directive (EU) 2022/2555) that sets minimum standards for cybersecurity within the EU. Does this directive also affect IVD and medical device manufacturers? If so, what does it require, and what should manufacturers do? This article provides answers. 1. What NIS-2 is about a) Objective…

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Clinical investigations of medical devices under the MDR – The regulatory pathway

The requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here. 1. Clinical investigations of medical devices a) Definition and objectives According to the MDR, a clinical investigation is During clinical…

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NMPA Usability Guidance: How to fulfill the requirements

The NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are. 1. Whom the NMPA Usability Guidance concerns a) Included and…

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MDSAP: Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit.  Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…

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