A question to the group: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), "year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number". One of my colleagues (in another company) was told by their Notified Body (BSI) that it has been interpreted (by whom?) that this means the month and year needs to be embedded into the actual serial number, such as XXZZ00001 whereas XX: month and ZZ: year (or similar). We have never encountered this with our Notified Body (TUV). Our S/N's cross back to a SN log which will reveal the month and year of manufacture. Who is right? Does anyone know where this "official" interpitation is coming from? The rational behind it? Thank You Dick Grobner Medical Graphics Corporation 350 Oak Grove Parkway St Paul MN 55127 651-766-3395 651-766-3389 (fax) dick.grob...@medgraph.com
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