European Commission proposes reforms to MDR and IVDR

The EU Commission published a reform proposal on 16 December 2025 in which the rules on medical devices and in-vitro diagnostic medical devices (IVDs) are to be simplified at EU level. The proposed changes aim to reduce bureaucracy and lower the burden on economic operators. The most important changes are summarised below:

I. Adaptation of classification rules

The classification rules are to be adapted. In future, certain devices (for example reusable surgical instruments and medical software) are to be placed in a lower risk class. This will markedly reduce the costs and time spent on conformity assessments. Software in particular is mainly to be attributed to class I, making it easier to market.

II. Simplified compliance requirements

The duty to designate a “person responsible for regulatory compliance” (PRRC) is to be eased. The Commission’s proposal looks to discontinue the detailed qualification requirements for PRRCs. For small companies, the obligation to have a PRRC in the organisation “permanently and continually” is to be replaced by the less strict requirement to only keep this person “available”.

III. Extended certificates of conformity and leaner processes

In future, certificates of conformity are no longer to be subject to strict time limits, but will be reviewed through regular, risk-based audits.

The conformity assessment procedure itself is also to be streamlined. The involvement of notified bodies in assessing the conformity of low- and medium-risk products is to be reduced. The procedure is also to be simplified by allowing notified bodies to replace on-site audits by remote audits. Unannounced audits should only be carried out for cause.

IV. Digital processes and documentation

As in many areas of law, the EU Commission is also seeking to step up digitalisation in relation to medical device and in vitro diagnostics law. For example, the plan is that it should be possible to document conformity assessment procedures digitally. Instructions for use for medical devices are also to be made available digitally. Under certain narrow exceptions in Implementing Regulation (EU) 2021/2226, it is already possible to make instructions for use of medical devices available in a form other than paper. This possibility is to be extended in the reform proposal.

Since medical devices and IVDs with AI components may also be subject to the AI Regulation (EU) 2024/1689 (AI Regulation), the intention is to ensure that relevant testing requirements under the AI Regulation can be integrated into the MDR processes in order to avoid separate, parallel structures under the MDR and AI Regulation.

V. Other simplifications and reductions in red tape

The European Commission’s proposal aims to reduce the bureaucratic burden, while preserving a high level of protection for patients in various areas. The proposed reforms summarised below have the aim of reducing bureaucracy:

• Reporting requirements will be made more practical: the time limit for reporting serious incidents will be extended from 15 days to 30 days (with exceptions, e.g. in the event of death). This will give manufacturers more time to properly investigate and assess complex cases.
• Moreover, when repackaging and relabelling products, the requirements to report these activities and to present a certificate from the notified body before placing the item on the market are to be removed.
• Rules relating to “in-house devices”, i.e. products that are exclusively manufactured and used in healthcare institutions, are to be made more flexible. These institutions will also be able to transfer in-house devices to other healthcare institutions on certain conditions.
• A definition for well-established technology devices is to be introduced. These products are to benefit from easier market access.
• Criteria and simplifications for conformity assessments are to be introduced for new breakthrough devices (BtX) and orphan devices for the first time.
• Regulatory sandboxes are to be established to test new technologies. These are temporary, strictly monitored test frameworks in which individual requirements of the MDR or IVDR can be temporarily adapted or waived for a specific product or technology in order to test innovations.

VI. European Medicines Agency to be strengthened

The European Medicines Agency (EMA) is to play a central coordinating role in relation to the MDR and IVDR, support national authorities, monitor bottlenecks and coordinate information obligations. Besides this, it is to monitor shortages of medical devices and IVDs.

VII. Key takeaways

All in all, the proposal represents a pragmatic approach to promoting innovation and eliminating red tape without significantly compromising levels of protection. However, its impact in practice will only be determined by how it will actually be formulated and whether it is implemented efficiently. The reforms give companies the opportunity to refine their processes and realign their strategy.

For economic operators, this ultimately means:

• closely monitoring the legislative process and implementation stages; paying attention to consultations.
• simulating reclassifications and their consequences for clinical evidence, technical documentation and costs at an early stage.
• adapting quality management, vigilance and reporting processes (including documentation of extended testing periods).
• seeking agreement with notified bodies (e.g. on audits, remote audits and long-term assessment plans).
• preparing digital documentation and delivery processes (e.g. instructions for use and conformity procedures).
• checking AI products for duplicate requirements under the MDR, IVDR and AI Regulation and adapting compliance strategies.
• examining the opportunities offered by regulatory sandboxes for innovative projects.