MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

MDCG has published a new guideline, this time concerning third country IVD manufacturers who intend to place their SARS-CoV-2 tests on the EU market.
We have summarized the most important facts for you in the flowchart below.

Do not forget about labelling: You need to ensure good quality of translations of your IFU and label into all official languages required by the Member States where you make the device available and especially where it will reach the final lay user.

If you need a Notified Body for your IVDR regulated tests, hurry up! As mentioned before only six NBs have been designated so far for IVDR. Since the number of devices needing NB involvement has increased dramatically, reviews by notified bodies are a bottleneck for the IVD community.