The regulation of medical devices and in vitro diagnostics (IVDs) in the European Union (EU) has undergone substantial changes in recent years.
The Medical Device regulation (MDR 2017/745) and IVD regulation (IVDR 2017/746) were introduced in response to advancing technologies and rapid industry growth. The regulations came into effect in May 2021 and 2022, respectively, and at the time marked a significant strengthening of safety and quality requirements for both medical devices and IVDs.
Implementation has proved challenging with widespread feedback from industry highlighting disproportionate costs, high administrative burden, and overall regulatory complexity as some of the key factors which are potentially limiting patient access to essential and innovative medical devices and impacting the EU’s competitiveness in this field. In response to this feedback, the European Parliament called for an urgent need to revise the MDR and IVDR in October 2024, with the aim of supporting continued growth and development within the sector.
The European Commission (EC) has since proposed targeted amendments to both regulations, which were published on 16 December 2025. The proposals aim to streamline both regulations by reducing unnecessary complexity and costs for manufacturers and notified bodies without lowering safety requirements, thereby creating a more reliable and robust system and making it easier to bring devices to market.
The proposed amendments are centred around key topics with the main elements of the proposals detailed below:
Key Topic: Simplification and Proportionality
- Person responsible for regulatory compliance (PRRC): The detailed qualification requirements for the PRRC and the obligation for small to medium-sized enterprises (SMEs) to have an external PRRC ‘permanently and continuously’ available are removed.
- Validity of certificates and recertification: The maximum period of validity of five years for certificates of conformity is removed meaning that recertifying devices will not be required. Instead, notified bodies will conduct periodic reviews proportionate to the device risk during the lifetime of the device.
- Clinical evidence, non-clinical data and clinical data: The range of data which may qualify as clinical data is widened to include other clinical experience published in peer-reviewed scientific literature. The conditions for relying on the clinical data of an equivalent device are also made more flexible, with the requirement to have a contract in place with the manufacturer of the equivalent device removed. Furthermore, the possibility to demonstrate a device’s safety and performance based on non-clinical data alone is expanded to include performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modelling or simulation and pre-clinical evaluation.
- Well-established technologies (WET): A definition for the term ‘WET’ is introduced expanding the current list of these devices which are subject to lighter conformity assessment requirements. WET devices are defined as those with simple, common, and stable designs, no previous safety issues, well-known clinical performance characteristics and have been on the market for a number of years.
- Classification Rules: Device classification rules under the MDR are adapted to allow for lower risk classes for certain devices, such as reusable surgical instruments, active implantable devices, and software.
Key Topic: Reduction of Administrative Burden
- Periodic Safety Update Report (PSUR): The frequency for updates to PSURs is reduced to a biennial cycle for higher risk devices (Class C and D for IVDs and Class IIb and III for medical devices) after the first year. For lower risk medical devices (Class IIa), an update of the PSUR is only required when new information is available.
- Reporting timeline of certain serious incidents in the framework of vigilance: The timeline for manufacturers to report serious incidents which are not related to public health threats, death, or serious deterioration of health will be extended from 15 days to 30 days.
- Changes after Certification: For changes after certification regarding the quality management system or the approved device, notified bodies shall clearly distinguish between changes that do not need to be reported, those that need to be reported without requiring prior approval and those that require prior approval before implementation. Where changes require prior approval, the notified body and manufacturer should agree on a predetermined change control plan enabling the manufacturer to implement changes in accordance with the plan without prior notification.
Key Topic: Innovation and Availability of Devices for Special Patient Groups or Situations
- In-house devices: The conditions for in-house devices (those manufactured and used only within health institutions) are made more flexible, allowing the transfer of these devices to another legal entity if this is in the interest of public health or patient safety. In addition, the condition requiring that no equivalent device is available on the market is removed for IVDs. Furthermore, in-house device exemption is extended to laboratory-developed tests used exclusively for clinical trials.
- Conformity assessment procedures for breakthrough devices or orphan devices: The proposals envisage minimal obstructions to pathways for breakthrough and orphan devices. It is proposed that the criteria and conformity assessment procedure for breakthrough technologies and orphan devices are defined within the regulations and, if the criteria are fulfilled as determined by an expert panel, manufacturers will have access to advice from the panel regarding the clinical development strategy of the device. Breakthrough and orphan devices will be subject to prioritised conformity assessment procedures and the possibility of a rolling review to reduce assessment timelines. In addition, certificates of conformance can be issued based on limited clinical data if the benefit outweighs the risk.
- Regulatory sandboxes: The proposals detail that regulatory sandboxes, which offer a controlled environment to develop, test, validate and use innovative products or technologies under regulatory supervision, may be established to address the needs of emerging technologies.
- ‘Grandfathering’ of legacy orphan devices: Legacy devices CE marked under the former directives that meet orphan device criteria may continue to be placed on the market beyond the transitional periods.
Key Topic: Predictability and Cost-Efficiency of Certification
- Conformity assessment procedures: Conformity assessment procedures are streamlined with reduced involvement of notified bodies in the conformity assessment of lower and medium risk devices (Class IIa and IIb and Class B and C) and the requirement for notified body involvement for Class A sterile IVDs removed. In addition, no systematic technical documentation assessment of representative devices will be required during surveillance activities. Furthermore, the possibility for notified bodies to conduct audits remotely instead of on-site and to conduct surveillance audits every two years in the absence of any safety concerns (in justified cases) is introduced.
- Clinical evaluation consultation procedure (CECP), performance evaluation consultation procedure (PECP) and early advice: The scope of the CECP for medical devices will be limited to Class III implantable devices, whilst the PECP for IVDs is removed and replaced with the introduction of early advice from expert panels for Class C and D IVDs.
- Notified body fees: Fee reductions of at least 50% for micro enterprises and manufacturers that apply for conformity assessment of orphan devices and at least 25% for SMEs will be introduced.
Key Topic: Coordination within Decentralised System
- Designation and monitoring of notified bodies: The assessment of applications from conformity assessment bodies and the designation/notification of notified bodies will be streamlined with the involvement of joint assessment teams composed of appointed experts who will be involved in the monitoring of notified bodies at least every two years.
- Dispute resolution mechanism between manufacturers and notified bodies: A clear dispute resolution mechanism between manufacturers and notified bodies is introduced with the authority responsible for notified bodies taking an ‘ombudsperson’ role.
- Enhanced role of external expertise available to the regulatory system: The role of expert panels and their composition are broadened. The expert panel will provide scientific, clinical, technical, and regulatory advice to the Commission, Member States, the Medical Device Coordination Group (MDCG), notified bodies and in certain cases to manufacturers.
- Support from EMA for the coordination of competent authorities: The EMA will provide scientific, technical, and administrative support for the coordination among national competent authorities in areas such as borderline and classification, to strengthen cooperation between national authorities and ensure a uniform application of the MDR/IVDR. Support by the EMA will also be provided to SMEs.
Key Topic: Further Digitalisation
- Digitalisation of compliance tools: The possibility to provide the EU declaration of conformity and certain information on the label in digital form is introduced. In addition, the submission of all documents and information under the MDR/IVDR electronically will be mandated.
- Digitalisation of conformity assessment: The possibility for manufacturers to draw up technical documentation, reports and other documents in digital form is introduced.
Key Topic: International Cooperation
- International cooperation and reliance mechanisms: International regulatory cooperation is strengthened through participation at International Medical Device Regulators Forum (IMDRF) and in the Medical Device Single Audit Programme (MDSAP) and global regulatory convergence through bilateral or multilateral reliance mechanisms or programmes is introduced.
Key Topic: Interplay with Other Union Legislation
- Combined studies involving medical products, medical devices and/or IVDs: A single application for combined studies with a coordinated assessment in accordance with Article 14c of the Clinical Trials Regulation (as amended by the EU Biotech Act) is introduced.
Key Topic: Artificial Intelligence
- Artificial Intelligence Act (Regulation (EU) 2024/1689): To prevent overlap between the MDR/IVDR and Artificial Intelligence Act and simplify the regulatory framework for artificial intelligence-enabled devices, the application of the Artificial Intelligence Act is limited to those provisions stated in the MDR for medical devices and IVDR for IVDs.
The next steps:
The EC opened an initial eight‑week consultation period in January 2026, which was originally set to close in March 2026 but has been extended on a daily basis until the adopted proposal is available in all EU languages.
Once the consultation period has ended, all feedback received will be summarised by the EC and presented to the European Parliament and Council with the aim of feeding into the legislative debate on the final text. Further updates to the regulations are therefore expected before the final text is adopted.
The expectation is that the new regulations will enter into force in 2027, however, the formal timelines have not been published to date.
Conclusion
Overall, the proposals aim to address the issues in the current EU medical device and IVD legislation that have affected innovation and availability of devices, without lowering patient safety standards. The new legislation looks to enhance the EU’s competitiveness and provide a clear and predictable regulatory framework with a focus on proportionality enabling faster access to essential devices.
How can S-cubed help you?
S-cubed can provide comprehensive support across quality and regulatory functions for both medical devices and IVDs, for example in the implementation or maintenance of compliant Quality Management Systems (QMS), provision of quality and regulatory audit services, training and developing quality agreements. Our expertise extends to regulatory affairs in the EU and UK covering regulatory strategies, device classification, technical documentation generation and submission, clinical investigation applications, and support with post-market surveillance activities and lifecycle management to ensure continued compliance.
We can keep you informed on the latest developments of the proposed EC targeted amendments to the MDR and IVDR.
Any Questions?
If you have any questions on this topic or want to reach out regarding your own device development programme, please don’t hesitate to get in touch. You can contact us here, via email (info@s-cubed.co.uk), and telephone (S-cubed Ltd: +44 1235 77 22 60).