CVRx, Inc.

Previous wording

As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements must be based on, among other things, the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence. This assessment must be based on clinical data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated or (3) both clinical studies and scientific literature. With respect to active implantable medical devices or Class III devices, the manufacturer must conduct clinical studies to obtain the required clinical data, unless reliance on existing clinical data from equivalent devices can be justified. The conduct of clinical studies in the EEA is governed by detailed regulatory obligations. 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.

Current wording

As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements must be based on, among other things, the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence. This assessment must be based on clinical data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated or (3) both clinical studies and scientific literature. With respect to active implantable medical devices or Class III devices, the manufacturer must conduct clinical studies to obtain the required clinical data, unless reliance on existing clinical data from equivalent devices can be justified. The conduct of clinical studies in the EEA is governed by detailed regulatory obligations. These may include the requirement

Previous wording

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. We are required to continue to submit updates for any substantial changes to the design, manufacturing or quality system for assessment against the MDR requirements. Annual audits by the Notified Body are required to verify that we continue to meet the MDR requirements. The current integrated platform technology, Barostim is approved under the MDR. Barostim Legacy is not approved under MDR, but can still be sold under the Active Implantable Medical Device Directive (“AIMDD”) 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.

Current wording

Regulations in the EU were updated to require compliance to Regulation (EU) 2017/745 on Medical Devices (“MDR”). Additional amendments to the regulation have delayed required implementation dates to December 31, 2027. Compliance with the new regulation required extensive updates to the quality system and device technical file documentation to new requirements. Updates were made and annual Notified Body inspections assessing compliance of the quality system to the MDR have been ongoing since 2020. 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. We are required to continue to submit updates for any substantial changes to the design, manufacturing or quality system for assessment against the MDR requirements. Annual audits by the Notified Body are required to verify that we continue to meet the MDR requirements. The current integrated platform technology, Barostim is approved under the MDR. Barostim Legacy is not approved under MDR, but can still be sold under the Active Implantable Medical Device Directive (“AIMDD”) 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.