Manufacturers of medical devices are required to heed the requirements of the MDR as of 26 May 2021, and manufacturers of in-vitro diagnostics are required to comply with the provisions of the IVDR as of 26 May 2022.
Devices in higher risk classes may still be covered by transitional periods in some cases, in which case they may still be placed on the market and supplied in accordance with the Directives previously in effect until the transitional periods expire.
The grace period is over
For devices in lower risk classes, specifically Class I medical devices and Class A IVDs, these transitional rules no longer apply.
In other words, these devices must (already) comply with the MDR and/or IVDR effective immediately!
But this is frequently not the case in practice. Market regulators and competitors have yet to respond in a systematic manner, likely due to the coronavirus pandemic as well as to their own need to obtain an overview of the “new” regulations and, in case of manufacturers, due to the need to ensure that their own products and production conform to the new regulations. However, these circumstances are now changing.
A wave of warnings is coming
The fact is that more and more companies, including non-European manufacturers, are not only familiar with the requirements of the MDR and the IVDR but are now in a position to manufacture and place their devices on the market in accordance with the new legal requirements. They have spent time and money to achieve this goal and rightly believe that they are at a disadvantage relative to competitors which have not made these efforts. These manufacturers are becoming more proactive and are no longer content with the ability to market their own devices as CE-marked medical devices. Instead, they are targeting competitors and competing products by issuing warnings, filing for temporary injunctions and making referrals to market regulators.
Surveillance authorities may prohibit distribution
At the same time, most competent surveillance authorities have adapted to the reality of the MDR and are no longer primarily concerned with conformity assessments for surgical masks and personal protective equipment. They too are increasingly “aiming” at verifying the compliance of Class I devices with the MDR: the focus is now on patches, tapes, heating pads, bandages, etc. as well as fascia rolls, ergonomic seat cushions and compression apparel. The list is endless.
The financial consequences for manufacturers of these devices, as well as distributors, are severe and may even be catastrophic in some cases: distribution of non-conforming devices may be prohibited by the authorities until compliance with the MDR is achieved and documented.
If they have not done so already, manufacturers of Class I medical devices and Class A IVDs should immediately concern themselves with the regulatory requirements for their devices and ensure their conformity before competitors and/or market regulators compel them to do so. Once competitors and the authorities are alerted to a lack of conformity, there will often be only enough time to mitigate the damages, but a self-determined course of action is no longer possible.back