NEW YORK (360Dx) – After a five-year long delay, officials in Europe are set to vote on new regulations governing in vitro diagnostics there.
The Council of the European Union will vote on the new measures on March 7, followed by a vote by the European Parliament. The new rules for IVDs, first proposed in 2012, were released last week along with a similar set of regulations for medical devices. If adopted, which is expected, the new IVD rules would take effect in 2022, while the new regulations for medical devices would take effect in 2020.
Among other things, the regulations set to create stricter enforcement of post-market monitoring of faulty products, increase protection of patients in clinical trials, and increase data requirements for study sponsors.
In its document the Council of the European Union said that changes to existing IVD rules are needed "to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation."
In a statement, the council further said the new regulations are focused on modernizing existing legislative framework "for the marketing of medical devices and to overcome legal gaps." The changes "should further strengthen patient safety, notably through the introduction of more stringent procedures for conformity assessment and for post-market surveillance and through requirements on manufacturers to general clinical data providing evidence on safety, performance, and any undesirable side effects. They should also allow rapid and cost-efficient market access for innovative medical devices."