MedTech Europe seeks regulatory changes and has urged the European Commission to act in a swift way and offer regulatory relief to the device as well as diagnostic industries, the trade group said on September 23, 2025.
Working along with 35 national associations, MedTech Europe has asked the commission to make three changes by the end of 2025 or early 2026. The request for short-term action happens to include a call for a delay to device re-certification in order to avoid a prominent bottleneck.
In a news that has indeed become a major highlight, MedTech Europe seeks regulatory changes and wats the officials to execute changes while at the same time working on certain longer-term reforms, which include the creation of a governance structure in order to oversee the notified bodies.
It is well to be noted that a consultation that closed in March 2025 went on to reveal the extent of dissatisfaction with the European Union regulations on medical devices as well as in vitro diagnostics. The respondents have gone ahead and termed the regulations as unreasonably complicated and terrible for EU patients and doctors, and they even addressed it as a mess. In response, the officials recently started a call for evidence in order to inform the changes to MDR as well as IVDR.
Apparently, in an open letter to the European commissioner for health and food safety, MedTech Europe has gone on to welcome the plans to alter the legislation, provided that the reforms go on to deliver a regulatory system that happens to be efficient, adaptable, innovation-friendly, and, of course, well governed.
Still, the trade group sees a need for the EU authorities to advance reforms simultaneously with the actions that are going to offer a more immediate relief device when it comes to device and diagnostic industries. The request for immediate action happens to include a call for targeted postponement when it comes to recertification needs for devices that happen to be already certified as per the regulations pertaining to medical technology.
Apparently, the EU has already postponed aspects in relation to MDR and IVDR in response to the warnings, which state that tight timelines can as well force products to come off the market. MedTech Europe now witnesses yet another bottleneck for devices, which happen to be due to shift to the regulations by 2028, and is calling for a deferment to make sure of a continued and consistent availability.
Besides, the trade group also wants the authorities to publish an implementing act that harmonizes the rules when it comes to notified bodies. MedTech Europe is seeking the act to set maximum timelines related to evaluation, define the scope in terms of changes to get notified, eradicate any sort of duplication of vigilance review, and help with early talks with manufacturers so as to lessen the burden as far as re-certification is concerned.
Interestingly, the trade group’s other short-term request happens to be for the commission to begin planned pilots in terms of regulatory pathways for pediatric and orphan as well as breakthrough fast and regulated pathways into the reforms of MDR along with IVDR.
In addition to this, certain other requests when it comes to longer-term reforms go on to include the creation of a single as well as an accountable governance structure in order to oversee the notified bodies. MedTech Europe remarked that the structure should ensure that the CE-marking system happens to be efficient as well as competitive across the world.
