Your path to class IIa
In order to ensure the marketability of health apps and other digital medicine products within the EU in the future, approval as a medical device has become practically inevitable. The certification process according to risk class IIa has to meet the same requirements as the certification according to risk class I. However, the involvement of a Notified Body is now mandatory and, especially in the context of clinical evaluation, significantly more demanding requirements must be met. Together with our partners, QuR.digital guides you safely and purposefully through the certification process.
Step 1: product analysis
Products without systemic risks, which do not provide inrofrmation for diagnosis or therapy, are generally assigned tp risk class I. This classification is based on the regulations of the medical device law and thus in future particular the Medical Device Regulation (MDR). We analyze your product and show you possibilities hpw tp üpsition yoour product in the best possible way within legal framework.
Step 2: Certification Support
Based on the completed product analysis, QuR.digital accompanies you through the enture certification process, from the creation of the intended purpose of the confortmity procedure by a notified body. Together with our partners, QuR.digital supports the certification process so comprehensively that, as a result, sustainable marketability as a medical device of risk class Iia can be guaranteed.
Step 3: Clinical Evaluation
Within the scope of certification according to risk classes IIa/IIb, significantly increased requirements are placed on the clinical evaluation of your product in particular. QuR.digital can support you in meeting these requirements with the "Digital-Active-Study" (DAS).