5 unchanged sentences
Compliance with these requirements was a prerequisite to affixing the CE mark to Barostim.
−Removed: To demonstrate compliance with the Essential Requirements and obtain the right to affix the CE Mark to Barostim, we underwent a conformity assessment procedure, which varied according to the type of medical device and its classification.
+Added: To demonstrate
+Added: compliance with the Essential Requirements and obtain the right to affix the CE Mark to Barostim, we underwent a conformity assessment procedure, which varied according to the type of medical device and its classification.
Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer could issue an EU Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements, a conformity assessment procedure required the intervention of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments.
7 unchanged sentences
The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.
−Removed: These may include the requirement
−Removed: 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 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.
8 unchanged sentences
The current integrated platform technology, Barostim, is approved under the MDR.
−Removed: Barostim Legacy is not approved under MDR, but can still be sold under the Active Implantable Medical Device Directive (“AIMDD”) approval through 2027.
+Added: Barostim Legacy is not approved under MDR, but can still be sold under the Active Implantable Medical Device Directive approval through 2027.
Failing to continue to comply with applicable foreign regulatory requirements, including those administered by authorities of the EEA countries, could result in enforcement actions against us, including refusal, suspension, or withdrawal of our CE Certificates of Conformity by our Notified Body (the National Standards Authority of Ireland), which could impair our ability to market products in the EEA in the future.
4 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.