Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.
A ‘Label’ is the identity of the product.
It allows the identification of specific devices on the market and facilitates their traceability.
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MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions
For the end user's safety and to place the Medical Innovation on the market, a manufacturer has a legal obligation to maintain design control files.
Understanding the Design File and the process of compilation.
Meaning of General Safety and Performance Requirements (GSPRs) and the checklist.
European Database on Medical Devices