The latest to take aim at the EU regarding the pace of MDR implementation were delegations from the USA, Canada and South Korea at the WTO Goods Council meeting on 8/9 July 2019.
According to notes of the meeting: “The EU risks disrupting its US$ 125-billion medical device market and harming patients’ access to medical technologies amid the backlogs and uncertainty arising from the implementation of new regulations”. The US said they were concerned about the insufficient number of notified bodies and the lack of availability of implementing regulations. They urged the EU to delay implementation for three years to allow industries to adapt.
While acknowledging the concerns, the EU responded saying that there are plans for transition mechanisms such as the possibility for manufacturers to use old certificates under previous regulations until May 2024.
In a submission to the WTO Committee on Technical Barriers to Trade dated 18 May 2019 (G/TBT/W/654), the EU said, “There are no grounds for the time being to explore any amendment to the transitional periods of the two Regulations. The EU is fully committed at this stage to ensure that the new system is introduced with no delay, to ensure a higher level of patient protection.”
Australia’s TGA also stated that they were aware of concerns over the possibility of insufficient notified bodies being designated by May 2020 and were “monitoring the situation”. TGA recognises CE marking for access to the Australian market.