EU State aid

State aid is essentially a publicly-funded gratuity to an entity for the purposes of activity for which there is a potential or actual market, and the aid is capable of affecting inter-State trade (see further, What is State aid).

The EU State aid rules (Articles 107 to 109 TFEU) give the European Commission (Commission) wide powers to investigate and order the recovery of illegally granted economic assistance which distorts the market in favour of the recipients of such assistance.

Economic assistance in any form whatsoever (ie an exemption from or reduction in the normal level of tax, loan or guarantee by the State), which is specific or selective in that it benefits certain undertakings or the production of certain goods, has routinely been considered to be State aid by the Commission and the EU Courts.

If a measure amounts to State aid and it is not notified to, or approved by, the Commission before it is put into effect, it will be unlawful. Some exemptions and exclusions apply and these are subject to detailed guidance from the Commission.

When does a measure amount to State aid?

State

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MedTech Europe leads industry call for EU to provide medical device regulatory relief by early 2026

MedTech Europe, together with 35 national associations, has urged the European Commission to take swift action on regulatory challenges affecting the medical device and diagnostic sectors. While EU officials are already collecting evidence to support future reforms of the medical device and in vitro diagnostic regulations, which are meant to simplify and improve efficiency, the signatories of the open letter argue that immediate relief is also essential. They call for a combination of short-term measures alongside longer-term legislative reforms. In particular, the letter asks for an implementing act to standardize the work of notified bodies, pilot projects for regulatory pathways covering orphan, pediatric, and breakthrough devices, and a targeted delay of re-certification requirements for certain products. According to MedTech Europe, harmonizing rules for notified bodies would help reduce duplication, speed up assessments, and ease the overall regulatory burden. The proposed postponement of re-certification deadlines is seen as necessary to avoid bottlenecks that could disrupt the supply of devices ahead of 2028. Looking further ahead, the associations want amendments to both MDR and IVDR that reflect the specific needs of each sector, alongside the creation of a single governance structure to oversee notified bodies and the CE-marking system, which they consider vital to the future of European medical technology regulation.

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