With MDR / IVDR implementation a regulatory paradigm shift is taking place. To highlight a few significant changes: the product scope has been expanded and more products must prove compliance with the regulations, like accessories and internet-based services. Furthermore, with the introduction of a new classification scheme (IVDR) and additional classification rules (MDR), reclassification must be carried out for all products. Advanced standards for clinical evidence to ensure safety and performance according to the specific device`s risk class have been established. Companies must also designate a ‘person responsible for regulatory compliance’ (PRRC). They must implement increased standards for post-market surveillance and obligatory vigilance in a life-cycle approach.
A more rigorous accreditation process and observation of Notified Bodies (NBs) also comes along with the MDR / IVDR implementation. More advanced control and scrutiny mechanisms are foreseen. Enhanced product individual device traceability via the implementation of unique device identifications (UDIs) and the launch of European Databank on Medical Devices (EUDAMED) – a unique, globally accessible platform that has been intended to continually collect individual safety and performance data of medical devices are additional fundamental changes. Moreover, there will be a basis for change for OEM (Original Equipment Manufacturer) and PLM collaborations. Suppliers and subcontractors will also need to increase scrutiny in their product distribution chain.
Identification of legal requirements qualifying your product production, documentation and monitoring is also needed to comply with the new framework.
Kalms Regulatory team offers to set up your regulatory compliance strategy to effectively manage your transition or initial certification. As a toolbox to rationalize the decision-making process, we perform a detailed gap analysis. That with its focus on all aspects of quality will result in a full picture and we will perform holistic project management with all relevant aspects.