Novartis Inhaler is First Device to be Certified Under MDR

Regulatory NewsRegulatory News | 11 September 2019 |  By 

BSI’s UK notified body announced Wednesday that the Novartis Concept1 inhaler is the first device to be certified under the new EU Medical Devices Regulation (MDR).

While previously classified as a Class I device, meaning it did not need to be reviewed by a notified body, the inhaler is now a Class IIa device under Rule 20 of MDR, which requires the notified body review.

Gary Slack, SVP of medical devices at BSI said:  “As a result of being the first designated EU NB under the new regulation EU 2017/745, BSI already has an increasing number of conformity assessments, currently being reviewed for the new regulation covering a range of products including Class IIa, IIb and class III.  This will enable many more of BSI’s clients’ products to follow this initial product and to be amongst the first to access markets under the new legislation.”

As more notified bodies continue to be designated (just four have been designated so far but more are expected by the end of the year), they will increasingly see heavy workloads in certifying devices under MDR, with the tight timelines outlined in the regulation.

BSI said in a statement that it is focused on ensuring its first batch of MDR reviews is “robust and that we assess accurately to the Safety & Performance requirements of the new EU regulations.  Equally importantly, we are on a daily basis increasing the capacity of our reviewer teams; we now have significant capability with experienced very well trained, fully competent experts to undertake MDR reviews. We are confident we can support our large client base in both renewing existing MDD certificates and achieving MDR certification.”


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Tags: BSI, MDR, Novartis

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