The Medical Device Coordination Group (MDCG) of the European Commission issued a position paper urgently calling manufacturers to transition to the Regulations and submit their application for their medical devices certification without further delay.
With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has significantly changed.
However, data provided by notified bodies shows limited progress in terms of applications submitted and certificates issued, being the situation even more worrisome for IVDs. While only around 8% of IVDs required notified body involvement for conformity assessment under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), this proportion is around 80% under the IVDR.
Manufacturers should keep in mind that the duration of the conformity assessment process once the application is submitted to a notified body currently takes longer than under the former directives. Notified body data reveals that a significant number of manufacturers’ applications are incomplete, potentially causing delays in the certification process. Given the established deadlines by the Regulations, manufacturers are strongly advised to intensify their efforts for an early transition and avoid further submission delays, as this could result in bottlenecks in notified body workflows and potential shortages of products in the market.
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