The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
RegDesk Regulatory Roundup
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
BfArM Guidance on Fast-Track Process for Digital Health Applications: Evidence – Positive Care Effect
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
The article describes in detail the further quality requirements imposed with respect to digital health applications intended to be marketed and used in Germany.