The European Commission wants to buy manufacturers time to comply with revised safety standards for diagnostic devices as a slower-than-expected transition to the new framework poses risks of shortages.
ADVERTISEMENTAn overhaul of the EU medical devices framework in 2012 was designed to revamp some obsolete rules dating back to the 1990s and improve safety and availability of these products.
Specific provisions were approved in 2017 for in vitro diagnostic medical devices, which range from glucose meters for diabetes monitoring to pregnancy kits, as well as tests to detect viruses such as HIV or coronavirus.
New requirements for in vitro medical diagnostics are formally to apply from May 2025 for high-risk tools and May 2027 for low-risk ones.
As the deadlines draw near however implementation of these rules has proven tricky with an estimated 15,000 applications to be filed for authorisation of new products and re-certification of those already marketed.
The EU executive decided to hedge by providing an extra two-and-a-half-year extension for in vitro diagnostics manufacturers to conform with the new rules, in a regulation presented on Tuesday (23 January).
Data collected by the Commission showed that market operators have not managed to take all the steps needed in time to place on the market their devices which now risk being discontinued or becoming unavailable.
“The proposal will provide relief for the sector, without compromising patient safety and care,” said EU Health Commissioner Stella Kyriakides, stressing that immediate action was needed to improve the availability of these medical devices.
An EU official told Euronews that this is not “a blank check” for companies as the extension is subject to conditions and that manufacturers must “also demonstrate a willingness to transition to new rules.”
Finding the root causes
This is not the first tweak to the initial plans for implementing the new framework as a longer transition for other types of medical devices was also proposed in January 2023.
The EU medical devices manufacturers association MedTech Europe stressed in a statement that this additional time must be used “to identify blockages and rectify existing issues.”
Together with the regulation, the Commission announced it will this year begin preparatory work for a targeted evaluation of the so-far bumpy legislation on medical devices.
“Going forward, we are determined to analyse the root causes that slow the transition and committed to take appropriate action,” said Kyriakides.
One of these causes is considered to be the lack of notified bodies organisations, which are those designated by member states to assess product conformity before medical devices are placed on the market.
There are currently only 12 bodies for in vitro diagnostics with eight more in the pipeline - a number that the commission considers sufficient to address growing demand.
The number of notified bodies is only one of the problems, however. “The biggest issue is the readiness of manufacturers - and this is particularly challenging for SMEs which are the largest producers of these devices,” said a commission official.
Some non-legislative initiatives accompany the proposed regulation in a bid to provide additional support and guidance to facilitate the transition.
A prior notice requirement was also included in the proposal with manufacturers and operators being asked to notify the competent authorities or the personal users of the devices six months in advance of a possible interruption of the supply.
Any requirement on manufacturers to notify critical device discontinuations should be kept as simple as possible to avoid imposing extra cost burdens, MedTech Europe said in a statement.
