Berater für internationale Zulassung
Medical 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.
DetailsSpecial authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…
DetailsIf a medical device does not (or no longer) meets the FDA’s requirements, manufacturers, distributors, and importers must recall it. This applies in particular if the device presents a hazard. In this article you will learn,
DetailsThe MDR and IVDR use the terms device category and generic device group without fully defining them. ISO 13485:2016 introduces the medical device family. Finally, the MDCG uses the term device range. The definitions of these terms determine the allocation of UDIs and the sampling of product files during certification. Therefore, it is important for…
DetailsThe authorization of medical devices in Japan is a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world. This article will tell you about the requirements you have to meet and the best way to overcome the hurdles.
DetailsThe CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health. This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in China. You will…
DetailsAbbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
DetailsIn a guidance document, the FDA explains how to implement a software change in a regulatory-compliant manner. It describes when you need a new 510(k) submission (Premarket Notification) and when you “only” need to document the changes.
DetailsThe FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsThe FDA requires a Design History File DHF in 21 CFR Part 820 (these are the “Quality System Regulations”). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two “files.”
