Quality & complianceOfficial

Dutch inspectorate flags Funke Medical mattress extensions over classification, labelling and IFU failings

🇳🇱 IGJ · Tue 10 Nov 2026

IGJ says an inspection found the products were not classified as medical device accessories and were sold without correct labelling or a compliant IFU, risking use errors.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning concerning Funke Medical GmbH's mattress extension, known in German as Matratzenverlängerung. The notice is dated 10 November 2026; the attached PDF is titled with 11 November 2026.

According to the inspectorate, an inspection established that the products had not been classified from a regulatory standpoint as accessories for medical devices. They were also sold without a correct label and without an instructions for use (IFU) that complied with requirements.

IGJ says these shortcomings can lead to use errors. As an example, it cites the risk of body parts becoming trapped. The source does not specify which user groups or settings are affected, nor how many units were sold.

The manufacturer's field safety notice (FSN) is dated 15 October 2026. The IGJ page links to a four-page PDF of the warning but the summary text does not describe any corrective actions, affected batches or countries beyond the Netherlands.

IGJ's page explains that manufacturers must monitor devices after they reach the market and improve them where needed. Where users face a risk, the manufacturer must act and inform users and the inspectorate through a field safety notice.

What it means for your team

  • Teams handling accessories or add-on products should check that their regulatory classification is documented and that the products are treated as medical device accessories where applicable.
  • Review labels and IFUs for conformity; the notice shows that gaps in these can themselves trigger a safety warning, not only technical defects.
  • Quality and vigilance teams should read the full FSN PDF for the specific actions requested, as the summary gives no details on scope or corrective measures.
  • Distributors and care providers in the Netherlands using mattress extensions may wish to check whether they hold the affected product.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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