ISO 13485/EU GMP Guideline Part I Matrix exclusively for delegates at the GMP & GDP Forum
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Combination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. On the one hand, the pharmaceutical legal requirements regarding marketing authorization and GMP must be complied with. On the other hand, the legal requirements for medical devices must also be taken into account. The quality regulations for medicinal products are fixed in the EU in the EU GMP Guidance Part I. For Medical Devices the ISO standard 13485 is relevant. How to bring them together?
Here ECA´s ISO 13485 vs EU GMP Guidance (Part I) Matrix helps a lot. It shows where the requirements in ISO 13485 are comparable to those in the GMP Guide and where they are not.
Participants of the ECA's GMP & GDP Forum, from 24-26 June 2025 in Barcelona, will receive the matrix, along with many other ECA Good Practice Guides, exclusively for download.