Background

The European Commission (EC) has committed to reassessing the MDR and IVDR as they exist today. Last month they formally launched the initiative, noting the next step is to analyze stakeholder feedback (including responses gathered through other channels, e.g., the European Parliament).

The reason for the initiative is, since their publication dates:

The EC has been implementing short-term measures to help ease market access, such as expanding the list of Well-Established Technologies (WET), rolling EUDAMED out in phases, as each module is ready for deployment, and allowing e-IFUs for all professional use medical devices. However, an underlying, permanent solution is required to effect real change.

Have Your Say: MDR/IVDR Revision

On 8 September 2025, the Commission published its formal notice opening the feedback period (Document Ares(2025)7425764) and launched a Call for Evidence to gather stakeholder feedback: HERE

All interested parties may provide feedback between 8 September 2025 and 6 October 2025 (midnight Brussels time): HERE

For manufacturers, this consultation is a structured opportunity to address the impact of the MDR/IVDR’s regulatory burdens, especially those affecting small-to-medium enterprises (SMEs) and low-to-medium-risk devices.

After the feedback period closes, the Commission will move to outline proposed revisions. With Commission adoption expected for Q4 2025, a draft amended regulation is likely to follow soon after the consultation ends.  

Overview: Targeted revision of the EU rules for medical devices and in vitro diagnostics
Type of Act: Proposal for a regulation
Commission Adoption: Planned for Q4 2025
Problem the initiative aims to tackle: While the overall objectives of the MDR and IVDR are shared by all relevant actors, various stakeholder groups and institutional actors consider that a lack of sufficiently predictable timelines for the certification process and diverging practices across the EU are undermining the efficiency of the process to obtain the CE marking.   Moreover, several requirements under the Regulations are seen as disproportionate to the actual risks presented by the devices, which results in unnecessarily high costs and burdens. Overly onerous requirements may prompt manufacturers, especially SMEs, to discontinue the supply of devices or delay their launch, with potential negative impacts on the level of patient care and public health. They may also negatively impact the competitiveness of the EU medical device market compared to other jurisdictions around the world.   Unless new EU action is taken, it is expected that these problems will continue to have a considerable impact on the medical device market and, consequently, on the care of patients in the EU.
What does the initiative aim to achieve and how: The initiative aims to simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework. More specifically, the initiative aims to: -reduce the administrative burden including reporting obligations; -enhance the predictability and cost-efficiency of the certification processes of notified bodies; -make the conformity assessment requirements more proportionate, especially for low- and -medium-risk devices and those that cater to special patient needs; -enable further digitalisation; -streamline procedures including those on governance; -enable the EU medical device sector to benefit from international cooperation including reliance, where appropriate; -better align the regulatory framework with other relevant legislation
Impact Assessment: The initiative will address the issues identified in the targeted evaluation. The revision would consist of targeted simplification measures, which are without viable alternatives, that seek burden reductions and greater predictability of the legislative framework. The initiative is not intended to modify the objectives of the legislation, thus ensuring the continued availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare. In this context, an impact assessment will not be carried out. Instead, the proposal will be accompanied by an analytical Commission staff working document, clearly explaining the proposed measures and presenting the underlying evidence, analysis and stakeholders’ views, as well as estimating the potential cost savings.
Consultation Strategy: Through the consultation activities, the Commission aims to collect the views and insights of relevant stakeholders on the objectives and the likely cost savings of the proposed targeted revision. These will complement evidence already collected in the context of the targeted evaluation. The consultation strategy aims to ensure that all the stakeholders concerned will have an opportunity to express their views and share evidence. The consultation process will include the following actions: – A Call for Evidence for interested parties to provide feedback in any of the 24 EU official languages (available on the Have Your Say platform). – Targeted consultation activities, e.g. survey(s), workshops, dedicated meetings.   A public consultation will not be carried out. There will be a particular focus on involving SMEs. The main stakeholder groups identified include: – the competent authorities in EU Member States and EEA states; – independent third-party bodies that assess the conformity of medical devices (‘notified bodies’); – economic operators, and the associations representing them, active in the field of medical devices; – healthcare professionals, and the associations representing them; – patients and consumers, and the associations representing them; – civil society organisations; – independent experts from academic and research institutes; – experts on regulatory affairs, and the associations and companies; – the general public; – European bodies, including the European Medicines Agency; – international intergovernmental organisations and international associations; – non-EU/EEA countries In line with the European Commission’s Better Regulation policy to develop initiatives informed by the best available knowledge, we also invite scientific researchers, academic organisations, learned societies, and scientific associations with expertise in medical devices, to submit relevant published and pre-print scientific research, analyses and data. We are particularly interested in submissions that synthesise the current state of knowledge in the relevant field(s).   Input received from stakeholders will be taken into account during the preparation of the targeted revision and will be reflected in the Commission staff working document.