In a statement to the World Trade Organisation (WTO) Committee on Technical Barriers to Trade, the delegation of the United States (US) has raised concerns about the implementation of the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR).
They have recommended a delay of three years to allow US exporters to adapt to the new requirements. In the statement, the US say they “support the development and enforcement of a well-defined medical device regulatory system which assures the safety and performance of medical devices”, however their industry is perturbed by the potential reduction in access to the EU’s $125billion device market, 16% of which is made up of US products.
The US industry has two main concerns. Firstly, there is an insufficient quantity of Notified Bodies (NBs) to perform certification activities. According to DG GROW, the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, no more than 12 of the 58 NB’s currently accredited under the old directives will be designated as operational under the MDR/IVDR by the end of 2019. This would not provide enough capacity to ensure continued regulatory approvals by May 2020 for MDR and May 2022 for IVDR.
Secondly, the US is concerned that the EU has not drafted enough implementing acts needed to maintain the products standards necessary for compliance with MDR within the deadline. Only 2 of the 18 proposed regulations have been issued, therefore EU standardising bodies are limited in developing the standards the industry needs to comply with MDR/IVDR.
The US have also stated that warehouse provisions are insufficient and the grace period intended to provided transitional relief is not long enough. They feel the grace periods are insufficient, as the “CE mark” product registrations which are compliant with the old directives may expire before the end of the grace period, in May 2024.
If the three-year delay is not feasible, the US has urged the EU to ask the NB’s to give priority access to the testing and certification of new products, which required testing for the first time, over products being re-certified to the new requirements. They have also requested that legacy products, which are currently deemed safe, be sold on the market until 2024.
To view the full statement, click here.