PPE Legal Series

BSI CE Notified Body Number changes and how it affects procurement and certification for PPE manufactured in 2020

For those of you, buying or sourcing PPE (especially the 3M 9300 series masks) in Europe, a very subtle change has occurred in the CE (Notified Body) numbers of the FFP1, FFP2 and FFP3 Masks and other PPE, if the CE certificate of that product was coming from BSI The British Standards Institute).A copy of this guiding article on CE Mark Number changes of PPE, with specific reference to 3M 9332+ masks has been discussed here in our new Business Legal Advice Website.

In our continuing series of such articles we will assist our readers and potential law clients in understanding how to understand 3M documentation especially LOT certificates and to check it for validity.As 3M masks have formed the majority of our procurement legal advice queries, we truly hope this information will be of use to buyers seeking genuine masks out there.

Meanwhile did you know the following fact?

There are over 50 EU Notified Bodies in total that can certify to the Medical Device Directives. However, not all of these Notified Bodies can certify to all categories of medical device products. Products holding a CE mark from any of the designated Noti ed Bodies can be marketed to patients, pharmacies, clinicians and other healthcare professionals in any EU country.

Nando is the Data Base of all Notified Bodies.

Visit the Nando Website to see the accurate list of designated Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/

 

The Josh and Mak Team
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