In the MDR iceberg (3)

210 days for an opinion on device-drug products

Under the MDR as under the MDD, Products which are device-drug combinations (whatever the proportion of the drug) must obtain an ‘opinion’ from a medicinal products authority designated by a Member State or the European Medicines Agency. No change here from MDD to MDR.

In point of fact, there is an improvement in the MDR: the medicines authorities must give their opinion within 210 days from the receipt of all necessary documentation [MDR, Annex IX, 5.2(d)]. However, that improvement may well be short-lived. The text says ‘…from the receipt of all necessary documentation.’ It is entirely conceivable that on Day 209 the authority dealing with your device could write and request more ‘necessary documentation’, in which case the 210 days starts again.

Furthermore, for device-drug combination products which have been on the market for ‘n’ years with a flawless in-use performance, also need to meet the above requirements. Good-bye current device-drug combinations for at least 5 months.