Targeted revision of the MDR / IVDR: on 16 December 2025, the European Commission presented a proposal for a targeted revision of the regulations governing medical devices (MDR – Regulation (EU) 2017/745) and in vitro diagnostic medical devices (IVDR – Regulation (EU) 2017/746).
This proposal is formalized in the legislative text COM(2025)1023 final, published by the European Commission:
Source : https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
At this stage, the proposal is under examination by the European Parliament and the Council and is not yet applicable, in line with the European legislative process.
Why a targeted revision of the MDR / IVDR?
Since the MDR entered into application in 2021 and the IVDR in 2022, the European Commission acknowledges that implementation of the regulatory framework has generated significant operational difficulties, despite its initial objective of strengthening patient safety.
In its official proposal, the Commission explicitly highlights:
- a high level of administrative complexity,
- long and unpredictable certification timelines,
- limited capacity of notified bodies,
- and a particularly strong impact on SMEs, potentially affecting the availability of certain devices on the European market.
These challenges have also been raised by the medical device industry, notably MedTech Europe, which has called for a pragmatic improvement of the MDR/IVDR framework:
Source : https://www.medtecheurope.org/2025/12/16/revision-proposal-is-first-step-towards-fixing-europes-complex-medical-devices-diagnostics-rules/
The stated objectives of the MDR / IVDR revision
1. Simplifying certain regulatory requirements
The Commission clearly states that this revision is targeted and does not call into question the fundamental safety and performance requirements.
The objective is in particular to:
- reduce redundant administrative obligations,
- improve the proportionality of requirements based on device risk class,
- clarify provisions that currently lead to divergent interpretations between Member States.
These orientations are detailed in the official legislative proposal:
Source : https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
2. Strengthening the digitalisation of procedures
The proposal also places strong emphasis on modernisation and digitalisation of the regulatory framework in order to improve the efficiency of conformity assessment procedures.
According to the legal analysis published by Baker McKenzie, the revision notably aims to:
- reinforce the use of existing digital tools,
- improve information flows between competent authorities, notified bodies and economic operators,
- enhance the traceability of regulatory procedures.
This orientation is consistent with the Commission’s broader communication on modernising the European medical device regulatory framework:
Source : https://commission.europa.eu/news-and-media/news/commission-proposes-new-measures-improve-health-and-healthcare-sector-2025-12-16_fr
3. Improving the overall efficiency of the system
The European Commission also aims to improve:
- the predictability of assessment timelines,
- the harmonisation of practices between Member States,
- the consistency of decisions taken by notified bodies.
These elements are identified as key levers to facilitate access to the European market while maintaining rigorous scientific evaluations, as also highlighted by Baker McKenzie:
Source : https://healthcarelifesciences.bakermckenzie.com/2025/12/19/the-eus-2025-proposal-to-simplify-the-medical-and-in-vitro-diagnostic-devices-regulations-mdr-ivdr/
4. Maintaining a high level of patient protection
A central point of the proposal is the explicit maintenance of a high level of public health protection.
The Commission specifies that the revision:
- does not weaken clinical evaluation requirements,
- does not remove post-market surveillance obligations,
- does not reduce safety requirements applicable to medical devices.
These guarantees are clearly set out in the official Commission document:
Source : https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en
What the proposal does not do
According to the European Commission, this targeted revision:
- does not repeal the MDR or IVDR,
- does not modify device classification rules,
- does not remove existing clinical requirements,
- does not constitute a full overhaul of the regulatory framework.
These points are explicitly reiterated in the explanatory memorandum of the legislative proposal:
Source : https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
Regulatory status: where do we stand today?
At the time of publication of this article:
- the proposal has been formally presented by the European Commission,
- it is under examination by the European Parliament and the Council,
- no application date has yet been defined.
Conclusion – The BluePharm perspective
The targeted revision of the MDR and IVDR, presented by the European Commission in December 2025, reflects a clear intention: to improve the operability of the existing regulatory framework and reduce uncertainty for companies, while limiting delays that ultimately affect patients.
At the same time, the high level of safety and performance requirements for medical devices remains fully intact.
In this evolving context, manufacturers and medical device stakeholders must both continue complying with the current framework and anticipate future regulatory developments in a structured and measured way, without haste or over-interpretation.
At BluePharm, we support manufacturers, start-ups and medical device developers in the detailed analysis of European texts, the assessment of their concrete impacts, and the structuring of robust regulatory and clinical strategies, adapted to a constantly evolving regulatory environment.
Monitoring the evolution of the text, understanding what it changes – and especially what it does not change – is now a key challenge to securing projects and European market access.
