Minimum MDR and IVDR capped QMS audit durations

BSI has been delivering In Vitro Diagnostic (IVDR) and Medical Device Regulation (MDR) quality management system (QMS) audits for over a year. Our operational teams have been gathering feedback on the processes and timelines. The increase in regulatory requirements has led to significant increases in the number of regulatory checks required for QMS audits under the Regulations.

We have therefore had to reassess our audit duration calculation framework to ensure we maintain robust audits. We have found that we may not reasonably cover all the necessary checks and conduct a full recertification audit of your QMS in the current time frames.

New minimum audit durations from 1 July 2021
BSI will move to a minimum timeframe of two-and-a-half days (excluding offsite planning and reporting time) to complete a stage 2 or recertification audit at IVDR/MDR legal manufacture sites from 1 July 2021. It is necessary to set this as a minimum in order to cover all applicable regulatory requirements of the quality management system regardless of the level of outsourcing. This is necessary to meet the requirements outlined in IAF MD 9:2017 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) and IAF MD 5:2019 Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems.

Where can I find more information?

• IAF MD9 reference document
• IAF MD5 reference document

Who can I contact for further information?
If you have questions or concerns, we recommend using the free material referenced. If you still have questions, please contact your BSI Client Manager.