EC Cautions on MDR/IVDR Impact on Device Availability

Regulatory NewsRegulatory News | 17 June 2019 |  By 

In a factsheet posted Monday, the European Commission (EC) acknowledged that the EU’s medical device and in vitro diagnostic regulations (IVDR) “could have consequences for the availability of medical devices for health institutions,” with the potential for some devices to "become temporarily unavailable."

The 7-page factsheet highlights the anticipated potential consequences from changes to the risk classifications of devices and IVDs, as well as the wider scope of both MDR and IVDR.

“For instance, manufacturers may choose to stop the production of certain medical devices,” the EC said. “Furthermore, if certain medical devices do not get their certificates on time these products may become temporarily unavailable. Ask your suppliers to inform you in good time about the availability of the devices you need.” The instructions apply to all EU health care professionals and health institutions.

Manufacturers, however, began making decisions around the production of a product and certificates issued since the 2017 publication of MDR and IVDR, which marked the 3-year and 5-year transitions for the application of the new regulations, respectively.

Gert Bos, executive director and partner at Qserve consultancy, recently spoke to Focus about the lack of coordination on devices across the EU. “Nobody knows if and what products will remain available to health care providers as there is no EU-wide portfolio coordination taking place,” he said.

The EC noted that MDR reclassifies devices and has a wider scope than the current device directive. And the wider scope of IVDR will result in about 85% of all IVDs being subject to notified body (NB) oversight, up from 20% under the current directive. Yet while two NBs have been designated against MDR so far, and the EC still expects to designate 20 NBs under MDR by year’s end, no NBs have been designated for IVDR.

Some NBs are dropping off too. One of the four NBs in the UK recently announced it will not to apply to be designated under MDR or IVDR.

The EC factsheet briefly explains the grace period that allows certain devices to be placed on the market up until 27 May 2024 and made available until 27 May 2025, to allow certain devices to coexist under the current directives or the new regulations with equal status under EU law.

“Devices that are in stock in health institutions can still be used after 2025 until they reach their expiration dates,” the EC said. But the grace period does not apply to class I devices. Devices that are subject to the clinical consultation procedure per MDR Article 54 cannot be placed on the market prior to the establishment of expert panels, while the market placement of class D IVDs is contingent on setting up reference laboratories.

The factsheet also describes new obligations applicable to health care professionals and health institutions, how these relate to manufacturers’ obligations and vice versa. An intersection between the obligations on both concerns the role of unique device identifiers (UDIs), which span across the device ecosystem for easier traceability and identification.

“For class III implantable devices, health institutions shall store—preferably by electronic means—the UDI of the devices they have supplied or with which they have been supplied,” the EC says. “MDR and IVDR invite member states to encourage and to require health institutions to store and keep the UDIs of the devices with which they have been supplied. Also, member states shall encourage, and may require, healthcare professionals to store and keep the UDIs of the devices with which they have been supplied.”

In addition to UDIs, new obligations on certain health care professionals and health institutions also relate to in-house devices, custom-made devices, the reprocessing of single-use devices and clinical investigations or performance studies.



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