Claiming equivalence with a device that is already CE marked can help medical device companies save time and money. But scandals with devices including hip replacements and breast implants have shown why the industry needs to pay careful attention when making these claims.
The MDR is being introduced in May 2021 to ensure medical devices sold in the EU have high levels of quality and safety. Every device on the market needs to be CE marked under the new regulation, which introduces sweeping changes to many aspects of the approval process. One way manufacturers can reduce the amount of work involved in achieving a CE mark under the MDR is by claiming equivalence with another product, as it will save them from performing costly clinical studies.
Compared with the Medical Device Directive (MDD), the MDR requires more substantiated evidence that a product is equivalent, which is harder for manufacturers to achieve. The Medical Device Regulations will require that technical, biological and clinical characteristics are shared when claiming equivalence to another device. So, if you are comparing two devices with the same characteristics, but made from different materials, that won’t cut it. There is therefore a greater need for a robust literature search, gap assessment and there may be a requirement to perform further clinical studies.