Hello,
We are trying to develop an evidence generation strategy for some future products (likely a IIb or III) to launch under MDR. There are some uncertainties on the level of evidence, and bridging to existing products, as well as some non-related clinical design questions. Under MDR there are expert panels for assessment of clinical evaluations (Article 106), and as I understand it they can be consulted for IIb/III in advance for advice on clinical evidence generation (article 61)
I was wondering whether any of expert panels as defined in Article 106 of MDR have been established. If not, is there a date for when they are to be formed? Have the different medical fields been defined?
Best regards
Ben
We are trying to develop an evidence generation strategy for some future products (likely a IIb or III) to launch under MDR. There are some uncertainties on the level of evidence, and bridging to existing products, as well as some non-related clinical design questions. Under MDR there are expert panels for assessment of clinical evaluations (Article 106), and as I understand it they can be consulted for IIb/III in advance for advice on clinical evidence generation (article 61)
I was wondering whether any of expert panels as defined in Article 106 of MDR have been established. If not, is there a date for when they are to be formed? Have the different medical fields been defined?
Best regards
Ben