Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”
If a syringe without content is regulated as a device then why would prefilling the device with a drug change its regulatory requirements for registration/approval?
Can you identify your critical suppliers, link each to their respective product codes and registration status? Many medical device regulatory affairs teams struggle to connect these dots.
The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.