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).
BSI operates two full scope Notified Bodies, which cover all NBOG codes for the Medical Device Directives (MDD, AIMD, and IVDD):
|Notified Body Number 0086||Notified body number 2797|
Kitemark Court Davy Avenue Milton Keynes MK5 8PP
|BSI Group The Netherlands B.V. Say Building|
John M. Keynesplein 9
1066 EP Amsterdam
During your checks, please make sure that the manufacturer or their distributor presents BSI NB 2797 certificate(s) accompany the document.The certificate will generally be presented by the following accompanying letter from a legitimate manufacturer or their distributor.
A proper BSI NB 2797 certificate is important as it shows that the manufacturer has completed the proper process of migration of the enclosed CE certificate(s), originally issued by BSI UK (0086) Notified Body to BSI Group The Netherlands B.V. which is a European Notified Body designated in The Netherlands for the following three directives: MDD (93/42/EEC), AIMDD (90/385/EEC) and IVDD (98/79/EC).The migrated certificates retain their original certificate references to ensure traceability on the BSI website and to maintain full visibility of the significant history of the previous certification changes for the product or product family concerned. This also means that the manufacturer registered with the new BSI Group The Netherlands B.V will maintain and continue with the full surveillance audit schedule set previously by BSI UK. The purpose of this maintained traceability ensures all regulatory requirements under the Directives remain valid and are assessed on an ongoing basis and manufacturers do not need to update their labelling immediately.
Example of CE Migration :As we have all seen everywhere on the Web, the typical 3M 9332+ mask images on e-commerce websites, show the CE 0086 (3M has its CE’s notified as BSI for its 9300 and other Euro models).
Case Study of BSI CE migration of 3M 9332+
Almost all of 2020 models (fresh production) for 3M 9332+ show the CE 2797 which is something many of our clients who were making bulk purchases of 3M 9332+ found confusing during the legal scrutiny of inspection reports of stock.Some clients even wondered in panic if they were buying counterfeit stock.
The most recent images from fresher batches of 3M 9332+below show the new CE 2797.
This information may also be important for you, if a potential seller is trying to hoax you into buying CE 0086 masks, representing them as ‘fresh production’.In our experience the 0086 LOTs are coming mostly from 2019 and the years previous to these, and that is one year missed on the 5 year shelf life of an average 3M Respirator.
This issue was addressed by our legal team and we truly hope that this exercise will allow our readers and potential clients to understand the need for having a proper legal team on board when buying such products.
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.