The ongoing saga of the in vitro diagnostics regulation – EURACTIV

The In Vitro Diagnostics Devices Regulation follows the path of its sister regulation on medical devices as the European Commission has extended the implementation guidelines for both legislations due to delays in compliance.

The Commission released on Tuesday (23 January) a proposal to review the timelines for companies to comply with the regulation to ensure availability and avoid shortages. While EU institutions and stakeholders agree with the extension the reasons for the difficulties in adherence to the rules create disagreements.

In-vitro diagnostic (IVD) medical devices are tests used on biological samples to determine the status of a persons health, ranging from self-tests for pregnancy to diagnoses performed in clinical laboratories.

The medical devices and in vitro diagnostics regulations entered into force in 2017 and applied in May 2021 and 2022, respectively. However, the transition is taking longer than expected, forcing the Commission to propose new timelines.

We consider that the sector needs a bit more time to comply with the new with the new rules, a Commission official told journalists during a briefing.

The need to extend the deadline was already brought up during the Health Council in December, where France presented a note to the Council warning about the slow implementation and the risk of shortages, which Austria, Belgium, the Czech Republic, Finland, Germany, Ireland, Italy, Luxembourg, and the Netherlands supported.

The note identified the main issues as: on the one hand, to the systems ramp-up and to the requirements and timeframes necessary to designate NBs [Notified Bodies] within this new framework and, on the other hand, to a lack of foresight on the part of some manufacturers.

Notified bodies are the organisations designated by a member state to assess product conformity before being placed on the EU market, a process that all medical devices must undergo under the new legislation.

Currently, there are 12 NB designated for in vitro diagnostics and eight more are expected to start their work in the next months, which according to the Commission is sufficient for the number of assessment requests they receive.

While the Commission does not consider this to be a problem, data from October shows that manufacturers submitted 335 applications for high-risk in vitro diagnostics and notified bodies have only issued 109 certificates.

Medtech Europe, the EUassociation for medical technology, told Euractiv that the small amount of notified bodies is not their only problem.

There are also inconsistencies in the implementation of the regulatory framework, such as variance among the Notified Bodies, as well as variance between official guidance and the legal basis of the regulation, a Medtech spokesperson explained to Euractiv.

Uncertainty for the companies

The other tricky aspect that explains the delay in the compliance of the new rules is the difficulties this creates for the manufacturers.

We also see from our data that while big manufacturers tend to be compliant already with the new requirement, its more challenging for the SMEs, the Commission official added.

In the case of high-risk IVDs, SMEs account for a big part of manufacturing, and their capacity to adapt to new regulations is more limited and can take longer.

The bigger issue that we also identified is not only the availability of the capacity but also the readiness of manufacturers, the official explained, adding that there is still limited awareness of the new requirements among smaller producers.

With this extension, the Commission said it wants to support the manufacturers to facilitate the transition, for which they are also proposing non-legislative initiatives such as materials to simplify the understanding of the rules and additional funding for specific devices.

Medtech Europe also addressed this issue, explaining that there is a lack of transparency regarding the information that will be expected from the companies during the certification process.

The timelines for conformity assessments and requirements over the certificate lifetime are often unpredictable and inefficient, posing a financial and resource challenge for companies, the association added.

According to the medical devices association, these deficiencies render the regulatory framework unpredictable, complex, slow, and costly, hindering medical technology innovation within the EU market.

The new extension will guarantee manufacturers approximately two additional years until the rules start to apply, moving the deadline to 2027 for high individual and public health risk devices and 2029 for lower-risk devices.

[Edited by Zoran Radosavljevic]

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The ongoing saga of the in vitro diagnostics regulation - EURACTIV