Medical devices and supplies have an essential role in, for example, the diagnosis, prevention and treatment of injuries and illnesses. They must be safe, reliable and effective.
The National Supervisory Authority for Welfare and Health (Valvira) monitors the safety of medical devices and supplies in Finland. The legal framework consists of three EU directives: the directive on medical devices, on in vitro diagnostic medical devices and on active implantable medical devices. While this may sound very bureaucratic, some of the products regulated by these directives are commonplace and are even used daily.
"Medical devices come in many shapes and sizes. They include, for example, ultrasound equipment, medical devices for dentistry, anaesthetic equipment as well as supplies used with the devices. The group also includes consumer products, such as wound dressings and contact lenses," says Product Manager Aliisa Siljander from VTT Expert Services.
"In vitro diagnostic medical devices include reagents and equipment used to process biological samples. The results guide the monitoring of the patient's physiological state and treatment. Products that consumers are familiar with include blood-glucose test devices and pregnancy tests.
CE marking indicates product safety
"The manufacturer must verify compliance in order to acquire CE marking for a product. Products are given a safety classification and, depending on the risks involved, their compliance can be verified by different means. Some product classes require an assessment by an independent third party. VTT Expert Services Ltd is a Notified Body for medical devices in Finland."
"We assess the manufacturer's quality system in terms of its suitability to produce safe and reliable products. Processes and methods play are important role in achieving this, which is why Notified Bodies do not test individual products. Assessment of product documentation is important in the assessment of regulatory compliance."
Documentation must specify the intended use for which the product fulfils the requirements on safety and performance. Clinical investigations, user experience, product labels, user guides and risk management are an essential part of the product's technical documentation.
"Once the company's quality system and product documentation have been assessed as being compliant with the relevant directive, the manufacturer drafts a Declaration of Conformity (DoC) and affixes the CE mark on the product. Without CE marking, the product cannot be placed on the market."
The Notified Body keeps participating in the process and performs annual visits after the initial assessment.
Stricter regulation will be introduced
While regulation and monitoring already takes place, the EU intends to introduce even stricter requirements in the future. The controversy surrounding the PIP breast implants that occurred while the current system was in place increased demands for stricter regulation.
"The European Commission has published regulation proposals to replace the existing directives. These proposals seek to increase regulation and emphasise the role of clinical investigations, introduce stricter regulation for products on the market and expand the scope of the regulations to include new products," Siljander says.
While waiting for the adoption of the new regulations, the Commission has already recommended increasing the monitoring to the extent allowed by current legislation. In the future, Notified Bodies are to perform unannounced visits in addition to their annual review visits.