A decision is soon expected on a corrigendum initiated in May by the European Commission (EC), to extend the existing transition period for certain class I reusable devices, including some software, that are being up-classified.
Class I devices currently make up 40% of all medical devices. Reusable class I devices, such as surgical instruments and endoscopes, will be classified higher by the incoming Medical Device Regulation (MDR), exposing them to an increased level of scrutiny and introducing new regulatory oversight. The aim of the proposed extension is to ensure patient safety by allowing a focus on certification of high-risk devices and reducing the risk of a shortage in supply of class I reusable devices.
The expected undersupply has been foreseen due to a reduction in the number of Notified Bodies (NB) and the delay in designation of NB’s under the MDR. This would lead to a lack of capacity for NB’s to assess Class I reusable device applications within the deadline, on top of all the other devices currently approved under the outgoing Medical Device Directive (MDD), inhibiting them from being placed on the market before the current May 2020 deadline.
The complex development process for most medical devices, combined with the new regulatory requirements and Notified Body approval, is likely to make the transition complicated and lengthy for most device manufacturers.
The corrigendum is now with European Parliament, and if passed, would give manufacturers of these devices an additional four years breathing space, to comply with the MDR. A decision is expected in the coming months.
Regulis is closely following the implementation of the MDR/IVDR to identify emerging compliance challenges and provide strategic support for device manufacturers, to ensure preparedness and a smooth transition.