Medical Devices and COVID-19
As the world faces the COVID-19 pandemic together, we would like to reassure you that BSI has been taking extensive actions to safeguard its people by managing the risk of infection within our operations and wherever we work with our clients. These actions are in accordance with the World Health Organization (WHO), respective local government restrictions and/or prevention guidance.
Our priority is, and always has been, patient safety, and at this current moment, we are continuing to work within the relevant legal and regulatory frameworks to do everything possible to put the safety of patients, our clients and own people first.
As a notified body, we must work with our Competent Authorities in both the UK (MHRA) and Netherlands (IGJ) to ensure our actions are effective, efficient and legal. We continue to allocate significant resource to ensuring products that help to fight, detect or monitor COVID-19 are available as soon as possible within the existing regulatory framework and in response to any derogations.
As part of our resilience planning, we have instigated our business continuity and pandemic response plans and have introduced remote auditing wherever permitted. Our technical documentation reviews will be completed remotely whilst advice is to remain at home. We are also in discussions with both our Competent Authorities, the UK government and the EU, with regards to how we will manage this situation should it continue for a significant period, as well as any impact this may have on IVDR and MDR date of application timelines.
Please visit our online resource page where you will find the latest information from us; this page will be updated frequently and provides you with an accurate overview of BSI activities.
We are grateful for the amazing passion and commitment demonstrated by our team here at BSI and thank them for the additional effort and flexibility they have demonstrated over the last few weeks.
We are also grateful to have such understanding clients and ask for continued patience as we continue to do all we can to support each and every one of you.
Please stay in touch with your regular BSI contacts over the coming weeks, and we wish you and your families every safety and the best of health.
Senior Vice President Regulatory Services (Medical Devices)
Dr Manuela Gazzard
Group Director Regulatory Services (Medical Devices)