“Don’t postpone the transition to IVDR”

Operators who have not yet started to adapt to the requirements of the new EU IVDR regulation are running out of excuses. This is the opinion of Helena Dzojic, Head of Unit at the Swedish Medical Products Agency, who continues to persistently spread her message: don’t postpone the transition.

The IVDR is the new regulatory framework for in vitro diagnostic medical devices that came into force in 2017, with many of the requirements applying from May 2022.

Currently, companies that have products certified under the old IVDD regulations need to comply with the new IVDR requirements by May 2025, May 2026 or May 2027, depending on the risk class to which the products belong. The new rules also include stricter rules for in-house manufactured products, which are commonly used in laboratory medicine.

Progress is slow, however. For a long time, the industry pointed to a lack of ‘notified bodies’ to certify diagnostic products, but this is no longer a valid excuse, according to Helena Dzojic.

“According to our data, the lack of capacity of notified bodies is no longer a problem, as it was some time ago. Now it’s more about raising awareness that you shouldn’t postpone the transition.”

The lack of capacity of notified bodies is no longer a problem

A common excuse she hears is that companies are hesitant about the costs.

“It’s an investment and meeting the new requirements will cost; we all know that. However, this industry has always focused on patient safety, so I’m sure they’re willing to pay to achieve that, but the decisions to start the transition need to be made - well, should have been made yesterday, actually.”

Otherwise, there is an obvious risk that many Medtech products will be taken off the market. A number of companies have already announced that they do not plan to IVDR-certify their entire product portfolio. Healthcare providers and labs need to keep track of this and review their supplier agreements, says Helena Dzojic.

The European Commission recently proposed extending the deadline for the transition period by two and a half years - a proposal that will now be reviewed by the Council of Ministers and the European Parliament.

“While there are strong indications that the proposal will be adopted, it is still necessary to raise awareness of the need for everyone to fulfil their responsibilities. The IVDR is there for a reason, and I think it is in everyone’s interest that patients get the right diagnosis, and consequently, timely treatment,” she says.

The EU Commission’s proposal and other news in the IVDR field are some of the topics Helena Dzojic will address as a speaker at the Lab & Diagnostics of the Future event, which takes place on 27 March at Life City in Stockholm.

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