Two new EU regulations were recently adopted to help regulate the over 500,000 types of medical devices and in-vitro diagnostic medical devices currently available in the EU. The medical devices regulation applies to the huge range of medical devices available – from relatively simple first aid technology such as sticking plasters, through drug delivery devices such as inhalers and insulin pumps, to intricate implanted devices such as pacemakers and larger devices such as x-ray machines. The in vitro diagnostic medical devices regulation covers devices for self-testing such as pregnancy tests or blood sugar monitoring systems for diabetics and complex laboratory equipment used to conduct tests such as HIV tests and cancer screening.
Previous EU legislation on medical devices comprised three Directives from the 1990s. These Directives were considered to be no longer fit for purpose following a few high profile incidents including the metal on metal hip replacement recall in 2010 and the ruptured silicone breast implants scandal in 2012. Consequently the EU decided to revise the medical device legislation to bring it up to date with technological and scientific developments and to restore confidence in the industry.
The new Regulations include a number of changes designed to ensure that all medical devices and in-vitro diagnostic medical devices on sale in the EU are safe and effective. Significant changes include:
- the coordination of clinical trials taking place in more than one EU member state to form a single assessment;
- stricter premarket testing and assessment for high-risk devices such as hip replacements, breast implants and pelvic meshes;
- placing Notified Bodies (such as the British Standards Institution, BSI) under increased scrutiny from competent authorities and giving them additional responsibilities, such as the right and duty to make unannounced inspections of manufacturing facilities;
- requiring manufacturers to have at least one appropriately qualified person responsible for regulatory compliance;
- extending coverage to include some aesthetic devices (such as coloured contact lenses) that have the same characteristics and risk profile as corresponding medical devices;
- introducing “implant cards” for patients with information about implanted medical devices;
- increasing transparency by creating a European Databank of medical devices and requiring manufacturers to collect and retain post-market clinical data to help identify potential safety risks;
- requiring devices to be fitted with a “unique device identification” so that devices can be readily identified and traced; and
- requiring manufacturers to provide financial compensation schemes that allow patients to be compensated if they are fitted with faulty devices even if the manufacturer goes bankrupt.
There is a transitional period of 3 years for medical devices and 5 years for in vitro diagnostic medical devices. Hence, medical device manufacturers and in vitro diagnostic medical device manufacturers have until spring 2020 and spring 2022 respectively to meet the requirements of the new Regulations. Medical devices that meet the current legislation are not exempt from the requirements of the new Regulations, although products placed on the market under the previous EU legislation may be exempt from clinical investigation requirements if they have adequate clinical data and if they comply with the relevant common specifications.
Since the transitional periods expire after the March 2019 deadline for leaving the EU set by Article 50, this legislation may not automatically come into force in the UK, although UK based manufacturers will have to comply with these requirements if they wish to market and sell their products in the EU. Manufacturers wishing to sell their products in the UK will not have to comply with the new Regulations if they do not come into force in the UK, however, this would mean that UK-based patients would not benefit from the same protection as those in the rest of the EU. Therefore, the UK government may choose to maintain the new Regulations after the UK leaves the EU, as this would enable UK-based manufacturers to export their devices to the EU and would ensure UK-based patients were provided with safe and effective devices.