Two great blogs by my colleagues Stefan Menzl and Giovanni DiRienzo on a topic which I feel has sort of "slipped by un-noticed" by many in the medical device world as we prepare for MDR!
MDCG 2020-12 makes it plain that for "combination products" (i.e. medical devices with ancillary medicinal substances or containing animal tissue) WILL have to re-do the consultation procedure with the Competent Authorities [CA] (or EMA) when they move from MDD to MDR. This COULD mean adding many months (7 minimum) to the timeline for getting initial CE Marking for such products under MDR!
- Do you have such products?
- Have you built this extra time into your timelines for converting your portfolio from MDD to MDR? It could mean the timeline from submission to the NB to approval is 12-24 months or so, not the 6-9 months many manufacturers are hoping for/expecting!
Now, it should be said in the case of no changes/minor changes, the MDCG 2020-12 does make it clear there is some wiggle room for the CA to "expedite" the review, so the consultation process may not add 7-12 months, but much less - but what IS clear now is that a consultation process WILL occur (so each RA team will have to assess how risk adverse they want to be with their estimates for product approval timing under MDR, which will impact launch strategy in Europe).
Furthermore, as my colleague Stefan Menzl points out, rule 14 explicitly removed the “liable to act on the human body” text, so many more devices (even with a molecule or two of medicinal substance within them) will now become device-drug combination devices and, therefore, will be subject to the consultation procedure and the additional time for initial CE Marking under MDR.
- Does this apply to your medical device?
- Have you built this into your regulatory strategy for Europe?
Food for thought. Well worth reviewing these blogs, and the MDCG 2020-12, to determine the impact on YOUR device.