On 16 December, the European Commission presented a proposal to reform the regulatory framework governing medical devices and in vitro diagnostic medical devices (IVDs). The initiative responds to widespread concerns raised by the industry in recent years, including lengthy, costly and unpredictable certification processes that risk hindering innovation and competitiveness without delivering proportionate benefits in terms of patient safety.
The Commission’s stated objective is to make the system simpler, faster and more effective, while maintaining high standards of patient health protection. At this stage, the initiative remains a proposal that will need to be examined by the European Parliament and the Council and may be amended during the legislative process. As a result, entry into force should not be expected before the end of 2026.
Despite the uncertain timeline, several of the proposed measures deserve immediate attention from manufacturers, distributors, healthcare operators and all stakeholders across the value chain.
Medical software: potential revision of classification rules
One of the most significant aspects concerns medical software. The Commission proposes to revise Rule 11 of the MDR, potentially expanding the scope of software that may be classified as Class I and therefore reducing the need for assessment by a Notified Body. This change could also have important implications for the interaction with EU artificial intelligence legislation, limiting the number of AI-based medical software products that would be classified as “high risk”.
Certifications: greater flexibility on validity periods
Under the current framework, certificates issued by Notified Bodies are valid for a maximum of five years. The proposal would remove this rigid cap, paving the way for a more flexible system and potentially reducing the burden associated with periodic re-certifications, while preserving continuous oversight of device compliance.
Electronic instructions for use: broader adoption for IVDs
The Commission intends to expand the use of electronic instructions for use (eIFUs) to include IVDs intended for near-patient testing, provided they are for professional use only. This represents a further step towards digitalisation and the reduction of logistical and environmental burdens.
International cooperation and regulatory convergence
The proposal strengthens the EU’s commitment to global regulatory cooperation by promoting initiatives such as the Medical Device Single Audit Program (MDSAP). Participation in internationally recognised audit schemes could facilitate simultaneous access to multiple markets, including the United States, Canada, Japan and Australia.
In-house devices: more flexible rules
For devices and IVDs manufactured and used within healthcare institutions, the Commission proposes a less rigid approach. In particular, the transfer of such devices would be permitted in specific circumstances, such as for reasons of patient safety, public health or the management of public health emergencies. With respect to IVDs, the proposal also envisages the removal of the requirement that no equivalent alternative device be available on the market.
Regulatory sandboxes for emerging technologies
Another noteworthy development is the introduction of regulatory sandboxes: controlled environments, supervised by competent authorities, in which companies may develop and test innovative technologies, including in real-world conditions, for a limited period and within a structured regulatory dialogue.
Dedicated pathways for breakthrough and orphan devices
The proposal introduces specific criteria for highly innovative (“breakthrough”) devices and devices intended for rare conditions (“orphan” devices). Where certain clinical and public health impact requirements are met, Notified Bodies would be required to prioritise conformity assessments, including through rolling review mechanisms. Manufacturers would also benefit from access to expert support in defining clinical and performance evaluation strategies.
Clinical investigations and performance studies: targeted simplification
Finally, the Commission proposes to streamline procedures for clinical investigations and performance studies, particularly where the risk to participants is limited. Key developments include:
• a single coordinated authorisation procedure for combined medicinal product–device studies;
• for IVDs, exemptions from prior authorisation for studies involving routine blood draws and simplified requirements for companion diagnostics using leftover specimens.
Looking beyond the proposal
In parallel, the Commission has also published a draft implementing regulation on quality management and procedural requirements for Notified Bodies, aimed at harmonising costs, timelines and levels of transparency across conformity assessment processes.
Conclusion
Although still at a preliminary stage, the direction of travel is clear: greater proportionality, enhanced regulatory dialogue and a framework designed to support innovation without lowering safety standards. For companies operating in this sector, now is the right time to begin assessing the strategic implications of these potential changes and to prepare accordingly.