West Pharmaceutical Services AZ, Inc.

Regulatory PRRC. Ensure the product’s Technical Documentation and EU DoC are established and maintained to date. Ensure the product’s post-market surveillance and reporting obligations as outlined in the EU MDR are complied with and fulfilled. Ensure the investigational product conforms to the GSPRs apart from the aspects covered by the clinical investigation and that every precaution has been taken to protect the health and safety of the subjects.; Ensure EUDAMED accuracy

Quality PRRC. Responsible for the product’s conformity in accordance with the Quality Management System under which the product is manufactured before the product is released to the EU market; ensure the product’s post-market surveillance and reporting obligations as outlined the EU MDR are complied with and fulfilled.