15 unchanged sentences
The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.
−Removed: These may include the requirement of prior authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee.
+Added: These may include the requirement
+Added: of prior authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee.
This process can be expensive and time-consuming.
3 unchanged sentences
Updates were made and annual Notified Body inspections assessing compliance of the quality system to the MDR have been ongoing since 2020.
−Removed: An application was
−Removed: made for Barostim to comply with the general safety and performance requirements of the EU MDR.
+Added: An application was made for Barostim to comply with the general safety and performance requirements of the EU MDR.
Final approval and certificates of compliance for both the technical file and quality system were issued on April 9, 2025.
9 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.