Executive Summary

The proposed amendments to Regulation (EU) 2017/746 (IVDR) – rules on medical and in vitro diagnostic devices – introduce significant changes that mirror and complement the MDR (Medical Device Regulation) reforms while addressing specific challenges unique to the in vitro diagnostic (IVD) sector. These changes aim to reduce regulatory burden, enhance innovation, and ensure continued availability of critical diagnostic tests while maintaining high safety and performance standards.

IVDeology’s Managing Director, Stuart Angell provides a summary of key proposals included within this long-awaited proposed change, ranked as his personal top five:

The IVDR Challenge

The IVDR (In Vitro Diagnostic Regulation) became applicable on May 26, 2022, and has faced implementation challenges similar to the MDR, including:

Limited notified body capacity (only 19 notified bodies designated under IVDR)
High compliance costs, particularly for smaller laboratories and manufacturers
Risk of IVD diagnostic test shortages
Complex requirements for devices serving small patient populations
Challenges with performance evaluation requirements

Due to the challenges explored above, the European Commission completed a targeted review. The outcome is a series of proposals to reduce the burden of regulatory complexity under IVDR, published on the 16^th December 2025.

It is highly recommended that manufacturers read the full proposal – and the commission provided a very useful tabulated summary (well done!) to make the proposed changes more relatable and understandable.

Top 5 Major Changes to the IVDR

Simplified Classification and Conformity Assessment

For Class A Sterile devices, which currently are subject to conformity assessment by a notified body. Under the proposals, this requirement will now be removed. While there is a need to align to harmonised ISO standards including ISO13485, the removal of the conformity assessment pathway represents a significant time and cost saving.

Reduced Assessment Burden for Class B devices

In the spirit of a risk-based approach for device classification. The sampling of technical documentation by the Notified Body as part of the conformity assessment for Class B devices will be reduced to sampling one device file per manufacturer’s portfolio. While this will reduce cost and time of conformity assessment for manufacturers with multiple Class B devices, it does not really support small and medium manufacturers who are intending to bring their first device to the market.

(Personally, I would have preferred a reduced amount of technical documentation for a Class B device as well as reduced sampling.)

PRRC requirements for SMEs reduced

For Micro and Small Manufacturers, the need to have a Person Responsible for Regulatory Requirements (PRRC) continuously and permanently available has been removed. This will allow greater flexibility to appoint an external PRRC to support regulatory compliance. For SMEs, this will reduce the burden and cost of using an external regulatory consultant to support the PRRC role.

Flexibility of In-House Exemption

Under the IVDR, Health Institutions who develop their own in-house test (therefore outside the IVDR) have been limited by the requirement to not have an equivalent CE mark on the market. This condition has now been removed, allowing more freedom for the development of lab-developed tests (LDT). In addition, central laboratories manufacturing and using test exclusively for clinical trials are included in the scope of the in-house device exemption.

Extension of Vigilance Reporting

Article 82 of the IVDR states that the reporting of serious incidents must be reported within 15 days. Under the new proposals this have been extended to 30 days for cases where it is not related to public health threats, death or a serious deterioration in health. This gives manufacturers more time to effectively triage, assess and report some lower risk vigilance cases.

Timeline and Transitional Provisions

The proposal was published on the 16^th December 2025 with adoption expected Q2 2027. The regulation is expected to come into force shortly after, with a publication in the Official Journal of the EU (OJEU).

Next Steps

The IVDR amendments represent a fundamental shift toward a more proportionate, efficient, and innovation-friendly regulatory framework while maintaining rigorous safety and performance standards. While the proposal offers a number of benefits, the changes will not result in quick fixes of the current IVDR infrastructure and key challenges remain for industry in adopting IVDR. In the meantime, the existing IVDR transition timelines continue to progress.

Recognising that the EU CE-mark represents the gold standard for conformity assessment, and is utilised for international recognition in many key markets (including the UK, where the regulations are also changing in the coming months), it will be interesting to see how the global approach to IVDR regulation will shift.

IVDeology specialises in guiding IVD manufacturers through the complexities of regulatory compliance and quality management systems, including ISO 13485 standard implementation and certification support, IVDR compliance consulting, gap analysis and remediation, and ongoing QMS optimisation. With the right support, regulatory compliance transforms from a burden into a competitive advantage, helping you build a culture of quality, resilience, and continuous improvement that positions your organisation for long-term success.

Whether you’re starting from scratch, preparing for your first IVDR audit, or optimising an existing QMS, our experienced consultants bring deep expertise in both regulatory requirements and the practical realities of implementing sustainable quality systems. Get in touch to discuss your specific requirements and discover how our integrated services can support your IVD success story.