August 11, 2023
Recent surveys of the European in vitro diagnostic industry indicate an ongoing risk of device shortages as too few manufacturers certify their products to the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Alarming results of surveys performed by MedTech Europe, the European Commission (EC), as well as Competent Authorities (CA) such as the Dutch Health and Youth Care Inspectorate (IGJ), foresee shortages of IVDs on the European Union (EU) market if manufacturers do not start transferring to Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices as soon as possible.
As we previously wrote, the IVDR significantly changes the risk classification of IVDs in the EU. Under the European In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD), only seven percent of all IVDs required Notified Body involvement; under the IVDR, Notified Body requirements will apply to 84% of all IVDs.
Lack of prior Notified Body involvement
As such, the majority of IVD manufacturers marketing their devices in the EU have never had Notified Body involvement under the IVDD, and therefore may experience difficulties and/or underestimate the time it takes to compile technical documentation aligned with the strict requirements of the IVDR.
Results of the IGJs survey (link in Dutch) showed that currently there are 20% of respondents indicating no plans to transition to the IVDR. This implies that shortages are unforeseeable. In addition, the majority of manufacturers surveyed (more than 50%) have either not started transitioning yet or are still working on it (22% had not decided).
Competent Authorities step up IVD market monitoring
The Dutch Competent Authority has indicated actively monitoring and naming bottlenecks within the EU and contributing to a solution to avoid discontinuation of healthcare as a result of possible IVD shortages. The regulator will also start surveillance at IVD manufacturers, which other EU Competent Authorities are expected to carry out as well according to their responsibilities that follow from Articles 96, 97, and 104 IVDR.
But in the end, it will require joint effort from all parties involved realize a rapid transition to the IVDR and avoid device shortages in the EU.
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