Ann: Appendix 3B, page-17

Need to be congnisant that CE mark in relation to the 'device' consists of radioactive payload, the impantation vehicle, the processes around the procedure, the manufacture, transportation, and storage of the payload, and the protocols and quality controls around the same.

12-16 weeks is based on information pertaining to the average medical device approval. This is not clamp, or similar. You only have to look at the faulty PIP breast implant scandal to know that BIS is not going to rush approval for an impaltable radioactive device...