Recently, the Australian TGA criticised the lack of Notified Bodies in Europe (we reported). Now the FDA mentioned this aspect as well. The authority is also critical of the timely introduction of laws to ensure compliance with the new product standards.
As reported by RAPS, the US are calling for the implementation of the MDR and IVDR to be postponed by three years. This should enable American exporters to adapt to the new requirements. If this is not possible, the EU should allow the sale of legacy products, which are currently considered safe, until 2024. Furthermore, the Notified Bodies are to be asked to prioritize medical devices requiring a new certification over those in need of a recertification.