As the world faces the COVID-19 pandemic together, we would like to reassure you that BSI has been taking extensive actions to find ways of working in this difficult time. 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 own people and clients first.
As an Auditing Organization, Conformity Assessment Body and Notified Body, we must work with our Competent Authorities in both the UK (MHRA) and Netherlands (IGJ), and our global accreditation bodies to ensure our actions are effective, efficient and legal.
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 see the latest document from the Medical Device Coordination Group (MDCG) regarding the situation: https://ec.europa.eu/docsroom/documents/40705. We recommend you read the document and consider how this affects your organization.
What impact will this have on you as a manufacturer?
Notified bodies have a finite resource for auditing activities, which is already stretched due to the requests for early renewals under Directives, implementation of the IVDR and MDR. We are prevented from utilizing remote auditing for certain types of audits, for example, unannounced audits and special audits, which require on-site assessment (such as the verification of implementation of specific corrective actions, which can only be assessed on-site). BSI is receiving a high number of requests to defer audits to the end of 2020; this will cause a significant resource constraint in Q4 of 2020 and have a substantial knock-on effect in 2021. Ultimately, this may result in BSI being unable to book you in for a deferred audit on your preferred date. This may also impact your ability to transition to IVDR/MDR in a timely fashion.
If you cannot support/host an audit within your stipulated regulatory timeline, certificates may be suspended, and your products will need to be removed from the market.
We ask you to place your audit schedule as a top priority within your organization when you look at your current resource planning. You risk having to remove your devices from the market if you do not meet the regulatory requirements of your products and systems.
If you currently have an audit booked in with BSI and you want to discuss the specifics, please contact the Coronamitigation@bsigroup.com email in the first instance.
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.
Yours sincerely,
Gary Slack
Global Senior Vice President Notified Body
