Berater für internationale Zulassung
In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485. 1. QMSR: The amendments to 21 CFR part 820 This is because the FDA decided on February…
DetailsFor many manufacturers of medical devices, an FDA inspection is associated with great stress. Many companies are aware of the possible consequences, such as a public warning letter and even criminal prosecution. But they often don’t know how to avoid these consequences without shutting down the entire company for days. This article shows how This…
Details1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes. a) Determination of the classes The FDA no longer defines three “Level…
DetailsThe EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet. 1. Placing on the market: Basics a) Definition…
DetailsDefining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers. Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers. 1. What does a regulatory strategy determine? a) Background Manufacturers of medical devices must comply…
DetailsThe term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, however, define what “substantial equivalence” is. Sounds complicated? Demonstrating equivalence is by no means only relevant in the FDA context. That’s why this article provides clarity – especially but not…
Details510(k) clearance is the primary procedure for obtaining marketing clearance in the United States. It is also referred to as Premarket Notification (PMN). This article provides a quick overview of the procedure and the documents that must be submitted. 1. General information on the 510(k) clearance by the FDA In contrast to the European jurisdiction…
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. 1. What is an importer?…
DetailsThe EU Medical Devices Regulation (MDR) regulates not only medical devices but also devices without an intended medical purpose, e.g., liposuction devices, breast implants, and colored contact lenses. In December 2022 – four and a half years after the MDR was published – the EU regulated the necessary details with two Commission Implementing Regulations (2022/2346 and…
DetailsMedical device certification, MDR certification, CE certification. These are terms that are used frequently. But is there even such a thing as medical device certification? This article answers the question. 1. Summary The short answer is: There is no formal medical device certification, CE certification, or MDR certification. However, manufacturers do require certifications or certificates.…
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