Berater für EMV und elektr. Sicherheit
The system architecture describes the components of a (medical) device and how these components interact with each other via interfaces. For standalone software, the system architecture and software architecture coincide. 1. Documentation of the system architecture a) Notation language The documentation should reveal the individual components and their interaction. It has been proven that using…
DetailsThe European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid. 1.…
DetailsMost manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. This also applies to medical device manufacturers, for example. 1. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. Standards are documents written by national or international standardization commissions…
DetailsDirective 2014/53/EU (Radio Equipment Directive (RED)) applies to devices that use Wi-Fi or RFID, for example. Medical devices that send a radio signal because they connect to the internet or are operated remotely also need to demonstrate conformity with the RED before being marketed. In this article, learn more about 1. Applicability of the RED…
DetailsMedical devices are increasingly based on closed-loop systems. “Closed-loop systems” are also mentioned in the Medical Device Regulation (MDR). In this article you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how you can save several hundred euros buying the…
DetailsThe EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies, 1. Background a) Objective With the Battery Regulation, the EU aims to modernize the legal framework for batteries. The regulation is a response to calls for a comprehensive revision and expansion…
DetailsCombination products consist of the combination of a medical device and a medicinal product. Since both medical device and medicinal product law could be applicable here, there are some special features that must be taken into account for products of this type. In this article, you learn more about 1. What are combination products? a)…
DetailsASCA 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…
DetailsThe term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article. 1. Case distinctions for medical device PCs Case A: Standalone software is delivered If you as a manufacturer only supply…
DetailsSwitzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland. However, since May 26, 2021 (for medical devices) and May 26, 2022 (for in vitro diagnostic devices | IVD medical devices), manufacturers from Switzerland as well as manufacturers from other markets (e.g., the EU)…
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