Recently, the European Commission published a proposal for changes to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This proposal reflects ongoing efforts to improve how these regulatory frameworks operate in practice. It is important to note that the text as published is an early draft. It is very unlikely to become law in its current form. The proposal will be reviewed, amended, and negotiated in the EU legislative process.
Manufacturers should not treat this as a set of final rules. However, it is useful to be aware of the direction in which regulators are thinking. Staying informed now can help companies plan ahead and avoid surprises later. MDS is closely tracking these developments and ready to support clients with interpretation and planning.
Background for the Proposal
The Commission’s proposal is described as a targeted revision of MDR and IVDR. It does not aim to replace the regulations. Instead it seeks to respond to implementation challenges that have emerged since these rules came into effect. Key concerns have included unpredictable timelines for certification, high administrative burden, constraints on notified bodies, and risks to device availability in the EU market.
The proposed changes reflect these themes and aim to improve clarity, predictability of outcomes, and efficiency of regulatory processes. They also express a continued commitment to patient safety and device quality.
Areas Covered by the Proposal
Adjusting Compliance Requirements
The draft proposal includes revisions to how certain regulatory requirements are applied. For example, it suggests modifications to the role and oversight expectations for the person responsible for regulatory compliance. The text also proposes changes to certificate validity to support a more continuous evaluation of risk and performance rather than fixed time periods.
If these changes are adopted, they could make compliance more proportional to product risk and lifecycle stage.
Reducing Administrative Burden
The proposal aims to reduce some administrative workload for manufacturers without reducing safety oversight. Examples include clearer procedures for notifying changes to devices after certification, more widespread use of digital tools for documentation, and increased acceptance of remote audits.
These measures are intended to direct regulatory effort toward areas that most affect patient safety and device performance.
Supporting Innovation and Availability
Another theme in the proposal is improving conditions for innovation and product availability. It introduces pathways that could benefit breakthrough and orphan devices. There are also proposed mechanisms to monitor and manage device shortages at the EU level.
Maintaining access to important devices in the EU market has been a concern, especially for legacy and niche products. The proposal attempts to balance regulatory rigour with practical availability.
Governance and System Coordination
The draft text strengthens coordination mechanisms within the EU regulatory framework. It suggests clarified procedures for device classification, more consistent use of expert panels, and dispute resolution paths between manufacturers and notified bodies.
These changes aim to reduce inconsistency and improve predictability for regulated parties.
What the proposed Annex changes could mean for technical documentation
Several of the most practical implications of the proposal sit within the Annex revisions, which directly affect how technical documentation is structured and assessed.
In particular, the proposal points toward:
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GSPR (Annex I)
Clearer integration of cybersecurity, software integrity, and lifecycle risk management into safety and performance requirements. This reinforces the expectation that GSPR justification is supported by ongoing risk management and post-market data, not only pre-market evidence. -
Clinical evaluation (Annexes I and II)
A more proportionate and flexible approach to clinical evidence, with explicit recognition of a broader range of data sources. At the same time, expectations remain high for traceability and alignment between clinical evaluation, intended purpose, and risk management. -
Post-market surveillance (Annex III)
Stronger emphasis on continuous, risk-based lifecycle oversight, with documentation designed to improve coherence rather than volume. -
Notified body assessment (Annex VII)
More proportionate, risk-based review practices, with clearer expectations around assessment depth and ongoing surveillance.
While these Annex changes are still at proposal stage, they already highlight the importance of clear, integrated documentation where GSPR, clinical evaluation, and post-market activities consistently support one another.
What This Means Today
At this stage, no immediate action is required. The proposal will change as it goes through legislative review and negotiation. It will be subject to amendment by the European Parliament and Member States.
However, manufacturers should be aware of the general direction of the proposal. Doing so can inform regulatory strategy, risk planning, and long-term compliance road maps. Engaging with regulatory partners early helps companies position themselves to adapt if requirements evolve.
How MDS Can Help
At MDS, we follow regulatory developments closely. We interpret proposals and offer practical guidance to help companies understand what changes could mean for their products and compliance plans.
If you would like to discuss the possible impact of these proposed MDR or IVDR changes on your device portfolio or regulatory strategy, we are ready to support you.
Stay informed. Stay prepared. Contact us at Kristian@mdsdenmark.dk or schedule a consultation via Book a Meeting. We are here to help you navigate potential changes in the regulatory landscape.