NEW YORK (GenomeWeb) – Two new sets of rules governing in vitro diagnostics and medical devices in Europe have passed, five years after they were first proposed.
The European Commission announced the passage of the rules today saying they will "establish a modernized and more robust [European Union] framework to ensure better protection of public health and patient safety."
The set of rules covering IVDs will take effect in 2022, while another set of rules covering medical devices will become effective in 2020.
The new rules, the EC said, will improve "market surveillance and traceability" and ensure that all IVDs and medical devices are designed "to reflect the latest scientific and technology state of the art." Additionally, they will create more transparency for consumers and certainty for manufacturers of such products, while strengthening international competitiveness and innovation.
Current regulations of the devices date back about 20 years, but variations in the interpretations of the rules and how they have been applied — as well as instances of product malfunctions — necessitated changes and updates to the rules, the EC said.
Changes included in the new regulations include a directive in which 4 out of every 5 IVD devices will need to be checked by a notified body before they are allowed on the market. Current regulation mandates only 1 in 5 devices need to be checked by a notified body. Also, a financial mechanism will be created to ensure that patients who have been harmed by defective medical devices will be financially compensated.
In addition, a simplified procedure will be created, allowing device manufacturers to register their product only once at the EU level.