MDD in 2018 - Company with no previous EU approval

#1
For a company that is seeking approval in the EU for the first time (e.g. no MDD certificates but going straight to the MDR), is it still worth going for the MDD certificates right now? Otherwise, this company will have to wait until mid 2019 to receive approval. They would like to get into the EU market as soon as possible. Are there companies still certifying to the MDD in 2018? if so, what would be the transition timeline for them?
 

FoGia

Involved In Discussions
#2
The MDD certificates will still be valid under MDR (until they expire), so in theory you can market the product until 2024-2025 but there are a few constraints that apply, the most important one being that there must be no significant changes in the design and intended purpose of the device and that the manufacturer can't change of notified body, so you better make sure that the NB will still be around (not all NB have applied for designation under MDR). Post-market surveillance under MDR for these devices is the same as for devices cleared in the frame of the MDR.
Another practical consideration relates to the NB's workload, 2018 should still be achievable but NBs will be working full steam on MDR filings from summer 2019 onward, that won't leave much room for MDD filings.
 

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