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Stuart attends MDSAP Forum in Germany

By July 2, 2024No Comments

BIVDA’s Regulatory Affairs Manager, Stuart Angell, headed to the MDSAP Forum. This is an annual 5-day event set up for the Regulatory Authority Committee (RAC) of the Medical Device Single Audit Programme (MDSAP) to liaise with each other.

This is the first year that this forum was opened up to industry (for days 2 and 3) and the Auditing Organisations (Notified Bodies) who support the MDSAP certification process. This year the event was held at the TUV Nord facilities in Essen, Germany.

The attendance of industry was widely welcomed, and will become a common part of the forum going forward. BIVDA will continue to play a role in providing industry feedback from our members on the possible utilisation of MDSAP in the UK, EU and continued use in the existing jurisdictions.

During the course of discussions, it was generally agreed that MDSAP had been successfully implemented in the initial countries, with many observers (WHO, Singapore) and affiliates beginning to utilise some elements of MDSAP certification and reports as evidence for meeting local QMS requirements. It was also widely accepted that the utilisation of the programme allows faster access to key jurisdictions, allows multi-agency support and communication, and allows possible harmonisation of regulations.

However, challenges remain regarding operational efficiencies. This is largely due to divergence, and interpretation, of regulation between jurisdictions, consistency of AO and centralisation of documentation. Further discussions continued on days 4 and 5 to identify strategies which improve efficiencies. It is important efficiencies are improved first before expanding the jurisdictions, as it may otherwise result in an overly burdensome process leading to delays and additional auditing time/costs.

Ben Kemp