TEAM-NB To Roll Out Evidence Of Compliance With Extended MDR Period Rules 'Soon'

Questions about how manufacturers are going to demonstrate their legacy products may remain on the EU market beyond the former 24 May 2024 deadline have abounded. One vital instrument to demonstrate ongoing compliance is soon to be available.

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Key Document Allowing Manufacturers To Benefit From Extended Transition Periods In Wings

EU notified body association, TEAM-NB, has approved the so-called Notified Body Confirmation Letter. This is a critical element for manufacturers of legacy products to be able to demonstrate that they are entitled to benefit from the extension of the MDR transitional period (as introduced recently in amending regulation, 2023/607. (Also see "MDR Amending Regulation Officially Published And Already In Force" - Medtech Insight, 20 March, 2023.)

It is due to be made available on the TEAM-NB website “soon.”

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