Your path to class IIa.
In order to ensure the marketability of health applications 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 with systemic risks, which provide information for diagnosis and therapy, are generally assigned to risk class IIa. Decisive for this classification are the regulations of the medical device law and thus in the future particular the Medical Device Regulation (MDR). We analyze your product and show you possibilities how to position your 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 entire certification process, from the creation of the intended purpose to the conformity 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, significantly increased requirements are placed on the clinical evaluation of your product in particular. QuR.digital can support you in meeting these requirements.