Roland chung
Trusted Information Resource
Hello,
The EU MDR states “It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.” However, “sufficient levels of access” is not explicitly defined. Should manufacturers have access to the technical documentation for any claimed equivalent?
Best regards, Roland
The EU MDR states “It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.” However, “sufficient levels of access” is not explicitly defined. Should manufacturers have access to the technical documentation for any claimed equivalent?
Best regards, Roland