The listing issue with the CE authority is not one of whether to...

The listing issue with the CE authority is not one of whether to allow listing, but into which category should the product go. It is technically an implantable device but does not stay implanted as it is absorbed - hence the difficulty in classification. The CE Authority have form on dithering with this issue in the specialty area of Ophthalmology with Viscoelastic (an implantable 'device' that does not stay implanted post surgery). They will be consulting expert panels etc etc,

It will get sorted, and whether it is a category 8 or 12 will not make any difference to listing but may impact re-imbursement in other markets (and ultimate pricing).

Buderim Neophyte