As compliance with Essential Requirement is necessary for establishing compliance of medical device with Medical Device Directive (MDD 93/42/EEC), Active Implantable Medical Device Directive (AIMDD 90/385/EEC) and In-vitro Diagnostic Directive (IVDD 98/79/EC). In the same way, with the enforcement of the European Medical Device Regulation EU 2017/745 and EU IVDR EU 2017/746; the medical device and In-vitro diagnostic device manufacturers are now focusing on EU MDR and EU IVDR compliance. One of the most important aspect of compliance is to ensure that the medical devices and IVD complies and conforms to the General Safety and Performance Requirements (GSPR).
In the EU MDR and EU IVDR, the requirements are expanded and detailed, however the topics are consistent with the previous directives. Some requirements are new which includes medical devices without a medical purpose and medical devices to be used by Lay person.
We at Maven, help you determine which of the new ‘safety and performance requirements’ will be considered as applicable, and to ensure an appropriate rationale for requirements deemed not applicable. The significant requirements will then be considered with respect to existing documentation, to identify gaps which may need to be addressed. Even for the most novel requirements, we shall advise you on how to clearly demonstrate compliance through testing, risk management, and other means. For the expanded labelling IFU requirements, we shall guide you to ensure that all required information is included.
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