As it was reported in an earlier post in April, the application date of the Medical Devices Regulation was postponed by one year, i.e. until May 26, 2021. This postponement will not, however, have any impact on the date of application of the In-vitro Diagnostics Regulation, (EU) 2017/746, which becomes fully applicable as of May 26, 2022, when the transition period ends.
Whilst, for some manufacturers the new MDR provides for an additional time after the date of application allowing them to place certain products on the market for four years thereafter, in most cases, in 2021 and 2022 respectively, it will be a legal obligation of manufacturers to comply with the respective MDR and7or IVDR provisions. Hence, it is time for manufacturers to consider the requirements, which are fiercer than those currently in place.
As a first step, the amendments of the risk classes should be considered. As regards the product scope, the definition of medical devices and active implantable medical devices covered under the MDR is expanded to include devices which do not have a medical intended purpose, or are designed for the purpose of “prediction and prognosis” of a disease or other health condition. In the IVDR the scope will be expanded to cover diagnostic (including Internet-based) services, genetic testing and other tests which provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
Just as for the clinical evaluation for medical devices, manufacturers of IVD devices must accomplish a clinical performance evaluation as an evidence with respect to product safety and performance, corresponding with the respective risk class. In addition, clinical and performance data on potential safety risks must be collected continuously during the life cycle of the product.
As the UDI system is introduced for medical devices, but also for in-vitro diagnostics, the traceability of devices throughout the entire product life cycle and especially within the supply chain the law on medical devices is aligned with the law on medicines in which traceability has already been obligatory for quite some time, in accordance with the Falsified Medicines Directive 2011/62/EU.
Just as the MDR, the IVDR does not provide a “protection of the existing registration”. Hence, all approved in-vitro diagnostics must be reviewed under the terms of the IVDR requirements after the valid IVDD certificate expires and must be then re-approved.
Both the MDR and the IVDR require the identification of a “qualified person” /‘person responsible for regulatory compliance’ and request increased post-market surveillance authority by the Notified Body and continuous safety and performance reporting.
As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification; implementation of the outlined measures should commence well in advance of the implementation of the applicable Regulation(s).
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