Avoid the five most common mistakes when submitting a Premarket Notification (510(k))

The 510(k), also known as “Premarket Notification”, is one of the most common procedures for the authorization of medical devices in the USA. The concept is based on demonstrating equivalence with a predicate device (equivalent device). But the same mistakes, which can result in the entire 510(k) authorization failing, are made time and again. It…

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Post-Market Surveillance and monitoring of devices on the market

Post-Market Surveillance (PMS) is a proactive and systematic process to derive necessary corrective and preventive actions (CAPA) from information about medical devices already placed on the market. We have created a Post-Market Surveillance checklist for you. With this checklist, you can find out whether you meet the regulatory requirements of the MDR for Post-Market Surveillance…

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MDCG 2020-6: Clinical data requirements for legacy devices

Currently, manufacturers of legacy devices can keep their devices on the market without demonstrating conformity under Regulation 2017/745 on Medical Devices (MDR). However, manufacturers will have to provide the necessary clinical data by the end of the transition period at the latest. The requirements for clinical data that can be used to demonstrate conformity have increased enormously under the MDR. Furthermore,…

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The Machinery Directive: Which parts apply to medical devices?

The Machinery Directive (2006/42/EC) is generally applicable to machines of all types. However, the directive can also be relevant for medical device manufacturers: both the MDR and the IVDR refer to it. If the Machinery Directive comes into play, requirements that go beyond those of the MDR and IVDR apply. Therefore, this article will give you an…

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ISO 20417:2021 – Finally some clear requirements for accompanying information

ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer establishes requirements for the general information that manufacturers have to supply with their medical devices and IVD devices. The authors have succeeded in presenting the criteria in a clear and comprehensible manner. ISO 20417:2021 is also on the list of standards to be…

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Substance-based medical devices: What you need to do now in order to continue marketing your legacy device under the MDR

Manufacturers of substance-based medical devices such as seawater nasal sprays, mucous membrane-soothing cough syrups, or osmotically active laxatives face several challenges once the Regulation (EU) 2017/745 (MDR) came into force: This article illustrates what can be done to overcome the regulatory hurdles and ensure the marketability of your substance-based medical devices beyond the transition periods.…

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Verification and validation of IVD medical devices

IVD medical device validation confirms the device’s medical purpose. IVD medical device verification, on the other hand, proves whether the IVD works as intended. In this article, we provide a five-step guide on how to carry out the verification and validation of your IVD medical devices in a targeted manner and without unnecessary effort. We…

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INMETRO and ANATEL certification: A requirement for authorization in Brazil?

When ANVISA registration is no longer sufficient As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device. Manufacturers should be aware of the cases in which they must…

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