Approval of IVDs (in vitro diagnostic medical devices) in the EU

In vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards. 1. Significant steps for…

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Vigilance system

This article tells you which regulatory requirements you must fulfill, how a vigilance system differs from a system for post-market surveillance, and how you can set up and operate a vigilance system quickly and in compliance with the law. 1. Definition and objectives of vigilance There are legal requirements worldwide for monitoring medical devices on…

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Pass an FDA inspection with confidence

For 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…

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Product liability: medical device manufacturers pay attention!

Neither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devices. However, manufacturers should be aware that a lot of legal regulations entitle injured persons to claim compensation if a defective medical device causes harm to a patient, user, or third party. Liability may result, for example,…

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Regulation (EU) 2017/746: In vitro Diagnostic Medical Device Regulation (IVDR) – February 2024

The European In Vitro Diagnostic Medical Device Regulation (IVDR) must be followed by manufacturers who wish to place in vitro diagnostic medical devices on the market in the EU. The Regulation (EU) 2017/746 In vitro Diagnostic Medical Device Regulation (IVDR) regulates the entire life cycle of in vitro diagnostic medical devices (IVDs) in the European market. The IVDR came…

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Radio 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 1. Applicability of the RED…

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