Medical laboratories in the crosshairs of the IVDR. What to do?

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. 1. What…

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ASCA: Accreditation Scheme for Conformity Assessment

ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works. 1. ASCA – The basics a) Who is affected by ASCA? ASCA…

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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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