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!
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 07-Dec-2022 04:25
From: Carolyn Melvin
Subject: QP Style Declaration for Medical Device Combination Product CTD Submission
We are a medical device manufacturer and are preparing our MDR submission of a Class III combination product and are required to submit a declaration of GMP compliance of the active substance in the format of the EMA QP Declaration. As a device manufacturer we do not have (or require) a QP, however, we are debating how to make an appropriate declaration. We have purchased a GMP audit report from a third party for the active substance manufacturing sites, which also hold a CEP. Is this sufficient to cover our responsibilities as a device manufacturer? Does anyone know what the level of liability is for the Quality Manager signing the declaration? Has anyone had wording approved already by a medicines agency?
Any comments appreciated.
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Carolyn Melvin
Livingston
United Kingdom
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