The European Commission on Monday proposed changes to simplify medical and in-vitro diagnostic regulations. The proposals, which were praised by industry group MedTech Europe, aim to simplify the regulations by reducing administrative burdens, encouraging coordination among regulatory bodies and including more provisions for devices intended to treat rare diseases.
“This revision is a long-awaited and necessary step to fix parts of the EU regulatory system that are clearly not working for patients, innovators and healthcare providers,” MedTech Europe CEO Oliver Bisazza said in a statement on Tuesday.
The European Commission expects overall cost savings of about 3.3 billion euros per year from the revision. The next step is to submit the legislative proposals to the European Parliament and the Council for adoption.
Key changes
The European Commission said the proposals are intended to address “unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.”
Some of the key changes include simpler rules for medical devices and timelines for conformity assessments to speed up device access. The European Medicines Agency will also have a stronger role, which the Commission hopes will strengthen coordination across the European Union.
One proposal would significantly alter how medical devices with an artificial intelligence component are regulated. Currently, medical devices that use AI in the EU are beholden to the AI Act and could be regulated as high-risk AI systems. The proposal would limit the scope of the AI Act that applies to devices.
The revisions would also lower the risk classifications for certain devices, such as for reusable surgical instruments or accessories for implantable devices. Laboratory developed tests would be exempt from certain requirements if they are used exclusively for clinical trials.
The changes include provisions for orphan devices, which are used to diagnose or treat rare conditions. Under some conditions, manufacturers would be allowed to market orphan devices that were lawfully marketed previously without needing to do a conformity assessment. According to the text, transitioning to MDR and IVDR from the previous regulatory framework has „led to the discontinuation of certain devices intended for small groups of patients, as the costs for the transition made it economically difficult for manufacturers to undertake conformity assessment.”
The proposal also calls for notified bodies to prioritize orphan devices or breakthrough devices.
“The proposed introduction of pathways for breakthrough innovation and orphan devices is critical for more rapid access to needed, safe and effective technologies,” MedTech Europe wrote.
The lobbying group supported improvements in governance and system resources, but said the proposal missed the opportunity to provide a single governance structure. MedTech Europe also emphasized that legislators should not lose focus on amendments to IVDR, which were included in the same proposal.
Future of MDR
MDR and IVDR went into effect in 2021 and 2022, respectively. However, a transition period has been extended to 2027 or 2028, depending on a device’s risk class, to give manufacturers time to come into compliance.
The regulations were intended to replace a framework dating back to the 1990s, due to concerns about safety issues and insufficient data on medical devices, according to a targeted evaluation of MDR and IVDR.
An early concern was a lack of notified bodies to conduct conformity assessments of devices before they can receive a CE mark. As of October 2025, 51 notified bodies had been designated, according to the evaluation.
The European Parliament in 2024 called for reforms to MDR and IVDR, and MedTech Europe called for regulatory changes by early 2026.
