Emerging Regulatory Challenges

Regulation (EU) 2017/746 (IVDR) sets a new milestone in the regulation of IVD medical devices but also creates new regulatory challenges for manufacturers who are now required to fully revise their quality management system and technical documentation for all products. With the new rule-based classification system, IVD devices will be classified into four risk classes which demand much higher documentation effort than before. Thus, new processes have to be implemented to address requirements such as unique device identification, performance evaluation or post-market surveillance.

How we help you

We accelerate your pathway to certification and market entry. With our renowned and proven expertise in clinical affairs, post-market surveillance and quality management, we ensure your IVD product is compliant to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). From creating performance evaluations and planning post-market surveillance activities to analyzing technical files and supporting your product lifecycle, our experts help you with individually tailored services to address your current and future regulatory needs.


We also provide seminars, training and workshops, both on-site and online, about the latest updates on the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, harmonized standards and guidelines. Contact us for further details.


Please contact us if you want more information or a non-binding offer on our IVD device services.