The COVID-19 pandemic causes travel and other restrictions leading to delays of initial certification audits under the Medical Device Regulation. The situation has been worsening during the past 6 months. If the current situation continues, COCIR expects delays in product launches (or even shortages) for certain imaging, electromedical, radiotherapy and software devices next year. This is especially concerning as the pandemic situation is worsening.
COCIR is making a concrete recommendation toward EU institutions to allow conducting initial certification audits remotely by using the latest digital technologies. Access to the recommendation in Related Files