Industry Proposes MDR Virtual Audit Solutions While Commission Remains Silent On Topic
EU-permitted notified body virtual audits should be extended to include those done under the Medical Devices Regulation so the sector can benefit fully from the one-year delay to the full application of the Medical Devices Regulation despite COVID-19 obstacles, says industry.
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While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.
With new EU medtech regulation in place, demand for qualified and well-trained staff at notified bodies is at an all-time high. As an abundance of new auditors are faced with a steep learning curve ahead, moves are afoot to harmonize practices.