With the IVDR Regulation (EU 2017/746), the conformity assessment of IVD devices has become significantly more demanding. Increased requirements for documentation, performance and risk management mean that preparation for certification is more critical than ever.
In this context, one key approach stands out: structured dialogue between the notified body and the manufacturer.
What does structured dialogue mean in practice?
Structured dialogue with a notified body is structured communication aimed at clarifying IVDR requirements, ensuring that applications are of sufficient quality and readiness, and identifying gaps before the actual assessment. It gives the manufacturer a clearer overall understanding of what conformity requires for their specific product. This is particularly important in the current regulatory environment, where requirements are both extensive and open to interpretation.
Structured dialogue with a notified body is a way to structure the certification process step by step and identify risks early, supporting preparation for the entire IVDR process.
A clear distinction: not consultancy
It is important to understand what structured dialogue is not.
It is not a consultancy service.
It does not include instructions on how to meet the requirements.
It does not influence the future certification decision.
The discussion focuses on which requirements must be met – not on how they should be implemented. Responsibility for selecting solutions and meeting the requirements always remains with the manufacturer.
Why is structured dialogue critical right now?
During the IVDR transition period, the greatest challenge is not the existence of the requirements themselves, but their correct interpretation and timing. According to internal analysis, many projects are delayed precisely because the requirements have not been structured early enough, the readiness level of the documentation is unclear, or critical gaps are identified too late.
Structured dialogue helps reduce these risks by bringing structure and transparency to the process.
SGS Fimko acts as a notified body under the IVDR (Notified Body 0598), which means that the dialogue takes place directly with the organisation carrying out the assessment.
Benefits for the manufacturer
- improve certification readiness
- reduce iteration rounds during the process
- clarify the interpretation of requirements
- support schedule management
The key point is that it does not speed up the process through a shortcut, but rather reduces delays caused by errors.
Summary
Structured dialogue is a key tool for successful IVDR certification. It helps manufacturers understand the requirements correctly, prepare more effectively and manage the risks of the certification process.
In the current IVDR environment, where requirements are extensive and timelines are critical, this can be a decisive factor for market access.
Start structured dialogue with SGS Fimko today. Contact us: IVD.devices.fimko@sgs.com
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
