Which action should a regulatory professional recommend for the launch of a new List B IVD?

Recommending to obtain Notified Body approval of the technical documentation and the quality system is essential because List B in vitro diagnostic (IVD) devices within the European Union require compliance with specific regulatory frameworks. List B devices, while they do not fall under the same stringent requirements as List A devices, still necessitate a certain level of oversight to ensure they meet the essential requirements outlined in the In Vitro Diagnostic Regulation (IVDR).

The involvement of a Notified Body provides necessary verification and validation of the technical documentation, which includes the product's design and development processes, as well as adherence to a quality management system. This step is crucial for achieving CE marking, which is mandatory for market access in the EU.

By securing Notified Body approval, the regulatory professional is laying a foundation that not only aligns with regulatory expectations but also enhances the device's credibility in the market. Establishing this certification can instill confidence in healthcare providers and patients regarding the device's safety and efficacy, which is particularly important in the competitive landscape of IVD products.