EU Battery Regulation: What medical device manufacturers need to know
The 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,
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Combination products: Applicable law and regulatory requirements (EU law)
Combination 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
DetailsASCA: 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.
DetailsIEC 61010-1 and IEC 61010-2-101: Requirements for IVD medical devices
The IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…
DetailsHarmonized standards: Evidence for medical device manufacturers
Most 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.
Switzerland: What (IVD) medical device manufacturers should be aware of
Switzerland 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)…
DetailsClosed-loop systems in medical devices
Medical devices are increasingly based on closed-loop systems. These “closed-loop systems” are already mentioned in the Medical Device Regulation (MDR). One example is a system consisting of an insulin pump controlled by a device with a glucose sensor. In this article, you will learn what closed-loop systems are, where they are used in medicine, and what…
DetailsSystem architecture (not only) for medical devices
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.
Systems and procedure packs
The 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.
DetailsRadio Equipment Directive (RED) for networked medical devices
Directive 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
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