Will additional IVDR requirements limit the release of new CE-marked products in the future?

Исследователь смотрит на пробирку с жидкостью
IVDR certainly raises the bar higher for manufacturers to introduce new IVD products in the European Union. Nonetheless Beckman Coulter Life Sciences is establishing the processes required to meet the new requirements, and we have a robust pipeline of next generation products in development. We anticipate no significant change to our plans to continue introducing new, high-quality CE-marked products to enable our customers to deliver cutting-edge diagnostic services.