Pathways to IVDR readiness and continued compliance

Are you ready to meet upcoming IVDR deadlines?

The In Vitro Diagnostic Medical Devices Regulation (IVDR) has officially replaced the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD), becoming applicable on 26 May 2022. Since this date, all ‘new’ IVDs, i.e. devices not previously covered by a certificate or declaration of conformity issued under the IVDD, must comply with the IVDR.

Regulation (EU) 2024/1860 amending Regulations (EU) 2017/746 (IVDR) was officially published in early 2024. While the transitional provisions have been extended for legacy devices, the deadlines for lodging formal applications under the IVDR are approaching rapidly.

In response to the increasing demand, Notified Bodies (NBs) have significantly expanded their capacity with more designations and additional technical and administrative staff. However, NBs are urging manufacturers to submit Technical Documentation applications as soon as possible. Delaying submissions until closer to the deadlines may result in reduced capacity and longer processing times.

While current capacity is not yet a barrier, the slow roll out of harmonized standards and guidance continues to pose challenges and risks to commercialization efforts. A recent survey by Team NB highlighted that while the completeness of submissions has improved, 75% of submitted files still lack critical information, leading to delays as additional data is requested before assessment can begin.

How Beaufort can help

The deadline for Class D devices is now less than a year away (26 May 2025), and for Class C and Class B along with Class A sterile devices, the deadlines are just under two years and three years, respectively.

At Beaufort we specialize in guiding you through the complexities of IVDR implementation. Our team offers:

• Expert interpretation of IVDR requirements
• Comprehensive gap analyses and compliance planning
• Drafting and reviewing of Technical Documentation for all product classes
• Assistance in responding to Notified Body comments

We will provide you with a clear, actionable roadmap to ensure your products meet the new timelines and leverage current Notified Body capacity effectively. Let us help you navigate these regulatory changes with confidence and efficiency.

EU Regulation Updates

Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amended Regulations (EU) 2017/745 and (EU) 2017/746.  Key updates include:

• Extension of Transitional Provisions: While there is an extension of IVDR compliance dates for certain in vitro diagnostic medical devices (Class C and B legacy devices), others (Class D legacy devices) have earlier compliance deadlines. Of note there are new eligibility criteria related to the transitional periods with their own deadlines.
• Gradual Roll-out of Eudamed: The EU-wide database on medical devices will have a gradual roll-out. Certain modules will become mandatory for use before all six modules are fully operational.
• Obligation to Inform Authorities and Economic Operators: Manufacturers have an obligation to inform authorities and downstream economic operators in case of an interruption of the supply of devices. This requirement is set to begin in January 2025.

The amendment provides additional time for some IVD manufacturers to transition to compliance with the IVDR. However, the eligibility conditions to make use of the transitional provisions may present challenges as they require manufacturers to meet specific deadlines for quality management system compliance and notified body applications.