Tag Archive for: EU MDR

Earlier this year, the EU extended the deadline for companies until 2027 or 2028, depending on the device, to comply with the law requiring companies to recertify their products. This came amid reports from doctors that the new legislation was causing shortages of lifesaving equipment because small companies making devices for small numbers of patients could not afford the new compliance process.

While some companies say the products they have cut have no impact on patients or profits, others say some of the withdrawn devices are essential, and doctors agree.