(ref.: EU Commissions Explanatory Memorandum in the new MDR and IVDR proposals)
Looking for cost-saving opportunities for manufacturers is a good idea. It should be noted that these cost savings will apply to all manufacturers, and not only to EU-based companies. However, these cost savings should not come with an unacceptable reduction in safety oversight. The reduction of Notified Bodies involvement would not have a major impact on reducing costs for manufacturers: compliant manufacturers still have to perform the relevant verification and validations, including clinical evaluations of their devices and show written evidence that medical devices are safe and effective. The costs associated to these activities will not change with the new proposal and encompass the majority of design and regulatory affairs costs for a manufacturer. It is not possible to pinpoint a real average cost of regulatory compliance, as each company produces different MDs that come with different requirements. All figures in that sense are voluntarily misleading to distort the debate and drive discussions on costs to sideline safety.
