The European Parliament has adopted tighter In Vitro Diagnostics (IVD) Regulations and Medical Device Regulations intended to improve the safety of these products for patients in the European Union (EU), while also adapting to the technological and scientific advances that have transformed the medical device sector over the last 2 decades. Under the new regulations, particular high-risk devices will undergo stricter premarket control; the rules will be strengthened for clinical evidence and diagnostic performance studies; and stricter requirements on the use of hazardous substances will be established. Additionally, the revised regulations bolster national supervision of the independent notified bodies that assess devices, and introduce a new identification system to improve traceability of devices, with the aim of enabling a swift response to safety concerns.
Along with aiming to protect patients in the EU, the new rules also strive to make it easier for manufacturers to navigate the regulatory process. Companies will only have to register their devices once at the EU level, rather than in all EU member states where their products are sold. Unlike the old IVD and medical device directives, the new regulations also apply directly to all EU member states, which will help eliminate varying conditions for patients and industry in different countries.
The updated regulations will take effect in 2020 for medical devices and in 2022 for diagnostics, while new requirements for notified bodies and the provisions of a new governance structure will kick in before the end of 2017.