News about GMP/cGMP


Implementation of the EU MDR/IVDR: USA also raises concerns

According to RAPS, a US-statement to the Committee for Technical Barriers to Trade of the World Trade Organization (WTO) from 24 July 2019, raises concerns regarding the implementation of the new European Medical Devices Regulation (MDR) and the Regulation on In Vitro Diagnostics (IVDR). The MDR is already due to enter into force on 26 May 2020, the IVDR in 2022.

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.


RAPS: Newsportal

WTO: News