Simona sak
Starting to get Involved
Dear Experts,
We performed a clinical investigation outside the EU (India) for initial CE marking of a product class I. This was conducted in accordance to ICH-GCP guidelines, schedule Y and its amendments, Declaration of Helsinki (Brasil, 2013) and the applicable regulatory requirement.
Now the product is a class IIa according to MDR and is under review by our NB and I have the following question from them: Why the data of Indian study population is transferable to European population. What analysis should I provide in this case please knowing that we conducted many PMCF studies in EU also?
Thanks in advance
We performed a clinical investigation outside the EU (India) for initial CE marking of a product class I. This was conducted in accordance to ICH-GCP guidelines, schedule Y and its amendments, Declaration of Helsinki (Brasil, 2013) and the applicable regulatory requirement.
Now the product is a class IIa according to MDR and is under review by our NB and I have the following question from them: Why the data of Indian study population is transferable to European population. What analysis should I provide in this case please knowing that we conducted many PMCF studies in EU also?
Thanks in advance
