Four questions for Karoline Mathys Medical devices: Healthcare’s versatile helpers

What is a medical device?

Anything used for medical purposes that is not a medicinal product. Imagine there’s been an accident and an ambulance attends. Nearly all the equipment and products in the ambulance are medical devices, from the stretchers and dressings to the defibrillator. The same is true in medical practices and hospitals. A dentist’s drill, X-ray machines, surgical instruments such as scalpels, CT scanners, surgical robots, implants and the monitoring equipment used in operating theatres are all medical devices. But so are simple products like reading glasses. In fact there are something like 10,000 different categories and half a million different medical devices.

How do medical devices get onto the Swiss market?

Unlike medicinal products, medical devices are not authorised by Swissmedic. The Swiss regulation for medical devices is heavily modelled on the EU’s conformity assessment system. Medical devices do not have to be tested and authorised by an authority before they are placed on the market. Instead, manufacturers have to assess devices and confirm their conformity with the general safety and performance requirements. If a device involves a moderate or high risk, they must consult a private-sector testing organisation known as a notified body. Conformity is confirmed by applying CE marking. Medical devices with the EU’s CE marking can also be used in Switzerland.

“There are something like 10,000 different categories and half a million different medical devices.”

How is the safety of medical devices monitored?

Medical devices not only have to satisfy technical standards, but, depending on the device in question, may also have to fulfil mechanical or radiation protection standards. They also have to be clinically assessed to determine their medical benefits and risks. In the case of the new devices, this can be done by clinical trials, for example.

Depending on the answers to questions such as “How long is the device used for and where – inside the body or outside?”, medical devices are categorised as follows:

• Class I : low-risk devices such as stethoscopes, walkers and dressings
• Class IIa: moderate-risk devices, such as hearing aids, contact lenses or dental materials
• Class IIb: elevated-risk devices such as ventilators, X-ray equipment, radiotherapy systems or defibrillators
• Class III: high-risk devices such as pacemakers, heart valves and other implants such as prosthetic joints

Given the sheer number and diversity of medical devices, broad specialist knowledge is essential for testing and assessing them. The EU therefore adopted a regulatory system based on private assessment bodies, of the type that has proven successful for “technical products” such as cars and household appliances, and Switzerland has chosen a similar system. This system stipulates which bodies are permitted to assess the conformity of which devices. There is only a very small number of assessment bodies across the EU that can assess the conformity of all types of medical device. The task generally involves several hundred specialists working together.

What duties does Swissmedic have as regards medical devices?

Swissmedic is responsible for authorising and monitoring assessment bodies in Switzerland and for approving and overseeing clinical trials of new medical devices. Economic operators such as manufacturers of medical devices, authorised representatives of non-Swiss manufacturers and importers have to register with Swissmedic. Switzerland is introducing mandatory registration for medical devices of the type that exists in the EU.

Swissmedic focuses primarily on post-market surveillance. For example, we conduct inspections to ascertain whether market players are discharging their responsibilities correctly. We assess reports of suspected non-conforming devices on the basis of the risk involved and may demand corrective action if necessary. Manufacturers, professionals and hospitals are obliged to notify Swissmedic of serious incidents involving medical devices. We work internationally with partner authorities on vigilance to ensure that risks are identified as soon as possible. Vigilance in the context of medical devices means the system for monitoring the risks involved in using devices.

Manufacturers retain primary responsibility for safety. We check their risk analyses and publish information on and monitor the implementation of corrective actions such as product recalls or safety updates. In addition, we have a specific supervisory duty covering medical devices in hospitals, and help improve the safety of medical devices in Switzerland by publishing the results of our market monitoring activities and issuing various information sheets and checklists.

To further improve international cooperation between authorities in a way that benefits product and patient safety, we are also working to establish harmonised standards within the International Medical Devices Regulators Forum, for example for software as a medical device or in terms of requirements for quality management systems.