Medical Device and IVD Regulations are Changing. Here is What you Need to Know

The long march to new medical device and in vitro diagnostic (IVD) regulations in Europe is now in its final stretch. From 2020 to 2022, the European Union will bring into force rules that redefine what medical devices and IVDs are and how they are regulated both pre and post-approval.

The broadest changes concern how medical devices and IVDs are defined. In 2020, the definition of medical device will expand to take in non-medical and cosmetic products, such as contact lenses and epilation lasers. Two years later, officials will broaden the IVD definition to cover genetic tests that show how likely a patient is to respond to a therapy.

Those rules change the products covered by the regulations. Others reset how medical devices and IVDs are regulated. After 2020, developers of medical devices will need to clear a higher evidence bar to show their experimental products are safe and effective enough for widespread use. This will also affect existing products, the manufacturers of which will need to seek recertification.

Manufacturers will also face new, more stringent rules once they receive certifications. Devices will need to comply with a UDI — unique device identification — system designed to track and trace their movements along the supply chain. This will entail adding UDI information that is readable by people and computer systems to medical device labels and packages.

The European Union is also stepping up post-approval safety monitoring. Manufacturers will have to upload details of adverse events and other safety incidents related to their devices to a central portal.

From a quality control and assurance perspective, the specifics of the regulations include multiple other points of interest. The law mandates the employment of someone responsible for regulatory compliance who has certain qualifications, although it provides some flexibility for small firms to avoid overburdening them.