What is a medical device?

A medical device is a product that is intended by the manufacturer for use with humans and is intended to fulfil one or more medical purposes. In this context, medical devices must be clearly distinguished from drugs, since medical devices do not achieve their main effect pharmacologically, immunologically or metabolically.

Medical devices are very diverse and can perform a variety of different functions. For example, they are used to diagnosing or monitor and treat disease or injury. They can also be used to compensate for disabilities or alter anatomy.

A subset of medical devices are so-called in vitro diagnostic devices, which are intended for testing human samples (for example, blood, urine, or saliva) outside the human body (i.e., "in vitro").

Examples of medical devices, which are often purchased for self-testing, are:

• Plasters
• Contact lenses and their cleaning agents
• Blood pressure monitors
• Clinical thermometers
• Pregnancy tests
• Condoms
• Wheelchairs

In Austria, as in other European countries, medical devices must bear CE labelling, subject to certain exceptions (e.g. trial products, custom-made products). CE labelling confirms that the product is safe and effective under the intended conditions of use and that any risks are acceptable in relation to the benefits.

What are the activities of the BASG in the field of medical devices?

The Federal Office for Safety in Health Care (BASG) is the Austrian authority responsible for overseeing the national medical device market and is responsible for enforcing the Austrian Medical Devices Act (MPG) and related regulations.

Since medical devices are marketable throughout the European Economic Area through their CE marking, the BASG works with European partner authorities to increase the safety of products in Austria and on the common market.

BASG performs the following tasks:

• Vigilance... is the collection and evaluation of serious incident reports and corrective actions. Within the framework of European cooperation, an exchange of experience with medical devices takes place. In this way, the safety of medical devices on the Austrian market is monitored.
• Market surveillance... is based on information from vigilance and other complaints from the Austrian or European market. Market surveillance activities verify that the characteristics and performance of medical devices comply with legal requirements.
• Inspections... are carried out at market participants (manufacturers, authorized representatives, health care facilities, etc.) in Austria. Inspections can relate to all aspects that can influence the safety, functionality and quality of medical devices as well as the health of persons.
• Delimitation and classification... is the determination of whether or not a product is a medical device and corresponds to the classification of medical devices in the correct risk class. This can be done either upon request, officially or in cooperation with other European authorities.
• Exemptions... are exemptions that can be granted in justified cases for medical devices that do not yet bear a CE marking.
• Certificates of free sale... are certificates that a manufacturer or an authorized representative has its registered office in Austria and that the product in question may be traded in the European Economic Area.

Does the BASG make approvals of medical devices?

Unlike pharmaceuticals, medical devices do not have to be “approved” by the authorities in order to be placed on the European market. Instead, the manufacturer must carry out a so-called conformity assessment procedure for his product on his own responsibility. In this procedure, the manufacturer must prove that his product is safe and effective and meets the specified legal requirements. For products with a higher risk class, the manufacturer must involve a so-called notified body as an independent testing authority. Only after the conformity assessment procedure has been successfully completed may the manufacturer affix the CE marking to his product.

The BASG is thus not involved in any “approval” of medical devices. Instead, BASG is responsible for market surveillance and vigilance of medical devices after they are being made available on the market. As part of this responsibility, BASG reviews suspicions that may indicate a medical device is not compliant, collects background information, and takes action to ensure the required compliance.

What is the Vigilance System?

The Vigilance System is a mandatory monitoring and reporting system for medical devices in Europe. National health authorities record and evaluate the serious incidents reported to them and the safety-related corrective actions initiated by the manufacturer, such as recalls. The vigilance system is designed to prevent recurrence of serious incidents by identifying and correcting problems with the design, manufacture, or use of medical devices at an early stage.

What is a serious incident?

Legally, a serious incident is an event that has had, could have had, or could have in the future, directly or indirectly, any of the consequences listed below:

• Death of a patient, user, or other person.
• Temporary or permanent serious deterioration in the health status of a patient, user, or other person
• Serious risk to public health

A serious incident may be caused, for example, by a malfunction, by a deterioration in the performance of a medical device, by inadequate instructions for use, or by a previously unknown effect.

Examples:

• An insulin pump delivered too much insulin despite correct input, causing the patient:to lose consciousness
• An implant screw has broken, requiring additional surgery
• An HPV test provides a false negative result, resulting in the patient not receiving adequate treatment and worsening health conditions

Who is responsible for reporting a serious incident?

Health care professionals and medical device manufacturers are required by law to report serious incidents involving medical devices that have occurred in Austria to the BASG after becoming aware of them.

Distributors and importers must also inform the manufacturer or, if applicable, the manufacturer's European authorized representative of any serious incidents of which they become aware (by patients, users, or health care professionals), who must then report them to the BASG.

Can I also report to the BASG myself?

If you have doubts whether your serious incident has already been reported, please first contact your attending physician or your distributor. They can make an initial assessment based on your information and, if necessary, submit a formal report to the BASG.

If you still wish to contact BASG, please send an informal email to medizinprodukte@basg.gv.at. Your notification should include the information listed below to allow for a complete assessment and also to avoid duplicate notifications. To prepare the notification, please refer to the poster provided by BASG, which explains the most common symbols on the packaging or instructions for use of medical devices.

• Information on the medical device
  • Name of the medical device
  • Name and address of the manufacturer
  • If known: Item number, serial number, lot/batch number, expiration date, date of manufacture
  • For implants: Information from implant passport
• Exact details of the incident
  • What exactly happened?
  • On which date did the described incident happen?
• Details of the person concerned
  • Name
  • Contact details of the hospital for queries

All information that enables the identification of the patient will be treated confidentially in accordance with legal requirements.

What do I as a patient find out?

After receipt of your report, you will receive a confirmation from the BASG, which contains the assigned business number. The BASG then informs the manufacturer of the affected medical device and, if applicable, the hospital about the reported serious incident and, if necessary, requests them to submit the formal notification to the BASG as required by law. Following the notification, the manufacturer must carry out the necessary investigations, the results of which are subsequently to be evaluated by the BASG. If necessary, the BASG will take further measures. Please note that only the manufacturer of the medical device is a party to the market surveillance procedure. For reasons of official secrecy, other persons – including patients – may not be given any information about an initiated investigation or its outcome.

What will happen to my medical device?

In order to determine why a serious incident has occurred, a root cause analysis must be performed. In this process, the product is usually examined by the manufacturer, as he has the necessary knowledge, methods, and equipment. For this reason, the affected product and any associated accessories are typically made available to the manufacturer. BASG then evaluates the manufacturer's root cause analysis.

I do not want the manufacturer to investigate the product. Can the BASG investigate the product?

You are free not to provide the medical device to the manufacturer. However, this may hinder the manufacturer's root cause analysis. BASG itself does not conduct product investigations.

Am I entitled to compensation or a replacement product?

The BASG is not responsible for this question. BASG refers to consumer protection organizations or legal action.

Who do I contact if I believe my doctor has made a mistake with a medical device?

The BASG is not responsible for this question. BASG refers to patient advocacy groups, consumer protection organizations or the legal process.

How and from whom do I find out whether my medical device is affected by a corrective action or safety information?

If a manufacturer carries out a safety-relevant corrective measure, the affected customers must be informed by the manufacturer. The information letter contains a safety notice in which the manufacturer must explain the existing risks, necessary instructions (e.g. software update, destruction, increased patient checks) and information for identifying the affected products.

The BASG may publish safety information on medical devices. These can be found on the BASG website in the Official News under Market Observations.

As soon as the European Database for Medical Devices will be available, safety-related corrective actions will be published in it.