As the European Union implements new Medical Device Regulations, it may pose some obstacles for manufacturers.
According to a press release from the European Community, the following will be covered by the new regulations:
In line with the current system, all medical devices, in vitro diagnostic medical devices and their accessories fall under the new regulations. In addition, certain aesthetic products such as coloured contact lenses or equipment for liposuction that need to be just as safe as existing medical devices will also be covered.
Under the new Regulations, both medical devices and in vitro diagnostic medical devices are divided into four risk classes. Depending on the risk class of the product, a different conformity assessment procedure is foreseen before the product can be placed on the EU market. In case of medium or high risk classes, Notified Bodies might be involved in the process.
The new regulations also include setting up a database named (EUDAMED) by spring of 2020 that will contain “a living picture” of the lifecycle of all products being available on the EU market. Additionally, the regulations includea device identification system based on a unique device identifier (UDI) that will allow easier traceability of medical devices and an implant card that will contain information for a patient about implanted medical devices that will make information easily available and accessible for the particular patient.
The change in regulations is one of the single largest regulatory changes in the EU in decades. The impact will be felt by any medical-related manufacturing organization doing business in the EU and will take several years to be fully implemented. However, there is an indication that some manufacturing organizations will need to reclassify some of their medical devices.
The new regulations include four device classifications (I, IIa, IIb, and III). The classifications are: non-invasive devices, invasive devices, active devices, and a broad category for extraordinary devices not fitting within the first three categories.
Organizations will also need to conduct rigorous post-market oversight. This will be due to increased focus on the use and efficacy of the devices including unannounced audits, product sample checks and product testing. Annual safety and performance reporting by device manufacturers will also be required by the regulating body.
As the changes are implemented, medical device manufacturing organizations need to keep a close eye on how the regulations are being rolled out and what modifications will force changes, more education and/or a different approach to the product.