The IVD Directive was published and came into force in the late 90’s, more than 20 years ago. It was considered suitable for the devices available at that time. After the 90’s, there has been a massive change in the IVD Industry with many new innovative technologies being introduced in the market. These new technologies have led to the launch of varied types of devices, for instance, cancer testing, genetic testing, companion diagnostics, predictive testing, and many more. In other words, the IVD Directive became outdated and did not cater to these new products.
Another major reason for this change was that there were many disgraceful events that rocked the medical device industry. Of particular concern were the hip implant and breast implants scandals. The first issue was about wearing away of the metals chromium and cobalt from hip implants and entering the blood stream causing metal poisoning. This has had far reaching effects on those patients who received these implants. The second issue was related to the manufacturer using silicone oil in the breast implant manufacture which was not of medical grade. The breast implants started rupturing prematurely causing scarring and inflammatory reactions in the patients who received them. Both these cases affected large number of patients and this led to public outcry over the events.
The aim of manufacturers and regulators is to provide devices that are safe, effective, and do not cause harm to the patients or users. The safety issues that occurred negatively impacted the faith of the European people on the medical device industry, as well as on the regulations in place to protect patients. The need for change and a strengthening of the IVDD was strongly felt by industry, the regulators, and the end-users. At about the same time that the MDD was to being revised to the MDR, the IVDD was also sought to be revised to address all the concerns over safety and effectiveness of devices and to keep it aligned with the MDR, other global regulations, and novel technologies.