Regulatory Services (Medical Devices) statement on Russia 11 March 2022

The Regulatory Services Division of BSI Group regretfully has had to make the decision to discontinue its services in Russia. Be reassured that we will regularly review the region's situation and may adjust our proposed action according to developments as they arise.

This decision has not been made lightly. Unfortunately, the circumstances, which are outside of the control of our Russian clients as well as that of BSI, have rendered it impossible for us to continue as a conformity assessor of medical devices to the extent necessary to permit surety that we are safeguarding the welfare of patients, wherever they may be.

Russia

BSI will inform all clients in Russia that all contractual relations will be terminated at the notice date of Thursday 10 March 2022.

BSI has communicated with all medical device clients who have sites within Russia, but where the legal manufacturer is based outside of Russia. We are seeking clarity from such clients concerning their relationship with those sites in view of the challenges of maintaining appropriate oversight of certificates.

To check the validity of certificates, please visit the webpage: https://www.bsigroup.com/validate-bsi-issued-certificates.

However, we confirm that we have terminated certificates in Russia from 10 March 2022.

Communications

We have confirmed our actions to both our regulators and our accreditation bodies.

As you can understand, this is a fluid situation, and we will adjust our plans as events develop. If you have any questions or concerns, please email GlobalMedical.DeviceMarketing@bsigroup.com.

We thank you for your support during this challenging time. British Standards Institution, Regulatory Services.

British Standards Institution, Regulatory Services