We want to inform you that BSI will be implementing critical microbiology regulatory changes under the EU Medical Devices Regulation (MDR), In Vitro Diagnostics Regulation (IVDR) and Medical Device Single Audit Program (MDSAP). The impact is summarized for you:
- Guidance from our Netherlands (IGJ) and UK (MHRA) Competent Authorities now requires microbiology technical assessments for applications of ALL sterile Class III, IIa, IIb devices under the MDR.
- Within BSI for existing clients adding MDSAP certification, we accepted the results of microbiology audits that were within 12 months of initial Stage II or upgrade audit as part of the initial MDSAP certification audit. For subsequent audits in the cycle, these audits were typically conducted independent of the date and scope of the QMS audits. The program now requires the QMS audits to take microbiology findings into account. As a result, BSI will typically conduct microbiology visits before the QMS audit to minimize the impact on clients ability to handle multiple audit streams. Therefore, we will transition the microbiology audits to occur at initial Stage II or upgrade audit and then at a reduced frequency of every three years at recertification covering all manufacturers’ sterilization methods.
Manufacturers with sterile medical devices under IVDR/MDR/MDD/IVDD
When implementing the regulations, the depth and range of conformity assessment activities for sterile devices require significant additional resources for manufacturers. To align with the overriding changes, the frequency of onsite microbiology audits will adjust from biennial visits to a visit every three years to match ISO 13485 and MDSAP certification cycles.
Existing BSI clients will transition their microbiology visits to recertification over the next three years. This change will also include MDD, AIMD, IVDD, and standalone ISO 13485 certifications.
Under the regulations (IVDR and MDR), microbiology technical file assessments for all sterile Class IIa, IIb, and III will align with current Technical Documentation submissions at the time of application and future sampling. (Exception for Class III custom implants which require onsite visit).
What does this mean for MDSAP certification?
For MDSAP clients, there will be a transition period to align the microbiology/quality management system (QMS) audits. The microbiology audit cycle will move to upgrade (if applicable) and recertification year.
There may be a delay in your microbiology audit if the current biennial schedule does not align with the recertification year or if the audit cycle was interrupted by Covid-19 pandemic. Once aligned, the next microbiology audit will be on a three-year cycle.
We will continue to inform you of any changes, which might affect certification and encourage you to visit our website regularly for the latest information. We ask you to place your audit schedule as a top priority within your organization when you look at your current resource planning.
If you currently have an audit booked in with BSI and you want to discuss the specifics, please contact us at Microbiology@bsigroup.com.
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 during these uncertain times.
Global Head of Microbiology