Carolyn, in this case I would recommend you become familiar with Articles 48-52 of the Medicinal Products Directive (2001/83/EC) which describes the requirements of a 'Qualified Person' and related activities (including testing of the medicinal product per batch, which must occur in the EEC - and as I'm sure you are familiar is a major point of consternation in the UK following Brexit). It sounds like this is what they are requesting, and is a significant additional hurdle for a device manufacturer as there are no analogous requirements for devices.
I take it that this is a case where the medicinal product function is 'ancillary' to the device (as covered in MDR Article 1(8)). In case you haven't already it would also be useful for you to familiarize yourself with the EMA consultation procedure for the medicinal product portion of the product.
Best of luck!
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
firstname.lastname@example.org+1 301 770 2920
JoinMy RAPS DashboardLearn More