Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.
Author: Pharma Intelligence
Published: 02 August 2019
Number of pages:2
The shortage of EU notified bodies is causing extended delays in testing medical products before they can go on the market. Part of the problem is related to Nando’s tardiness in updating their databases when new notified bodies have already been designated. The European Commission has stated, as of August 2019, that there are four new notified bodies available, though Nando has registered only two. There is a large volume of new products that need to be tested before the new MDR regulation begins to apply in May 2020. As such, new notified body appointments by Nando are urgent.
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