Medical devices: from glasses to pacemakers

Before a medical device can get onto the European and thus the German market, it must undergo a procedure similar to that used for the authorization of medicinal products. This is known as a conformity evaluation process. During this process, the manufacturer must prove that the device is safe and its description is accurate. Unlike with medicinal products, however, this is not a governmental authorization. Medical devices are tested by qualified, federally authorized bodies, such as TÜV or DEKRA. These then issue a certificate. 

When is a clinical trial required? 

Some medical devices have to be tested in clinical trials. This is the case if there is insufficient data to prove the safety and performance of the device. The necessary data has to be determined using clinical trials. If sufficient data already exists – for example in relation to other devices of the same type – no clinical trials are required.   

To perform clinical trials on medical devices and performance trials on in-vitro diagnostic devices, manufacturers usually require the approval of the responsible higher federal authorities – the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). The responsible ethics commission must also agree to the trials. In-vitro diagnostic devices include rapid tests like COVID tests, for example. 

The CE mark is a kind of quality seal. For medical devices to be placed on the European market, they must have a CE mark.

The CE mark can only be displayed if the product has been proven to meet the basic safety and performance requirements. This occurs during the conformity evaluation procedure.

If a medical device has received the CE mark and therefore been authorized for placement on the market, it will continue to be monitored by the relevant authority. Furthermore, the medical device monitoring and reporting system records all incidents and risks that retrospectively occur.  

What are incidents? 

In simple terms, incidents can be described as any kind of product defect or malfunction, including any undesired side-effects of a medical device. 

Serious incidents are incidents where the medical device has or could have caused someone’s health condition to severely deteriorate. This means that even a potential risk to health can be classed as a serious incident.   

Examples of serious incidents involving medical devices include: 

• a life-threatening illness or injury 
• permanent impairment of a person’s body structure or bodily function  
• the need for surgery  
• hospitalization 

Serious incidents must be reported to the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). The reporting obligation particularly applies to manufacturers and professional users. However, private individuals can also report incidents.

What are the consequences of a serious incident?  

If a serious incident has been detected and reported to the Federal Institute for Drugs and Medical Devices (BfArM), the manufacturer must investigate it. BfArM then evaluates the risk on the basis of the data collected. If an unacceptable risk is found, the manufacturer must introduce countermeasures. This should ensure that future patients are not subjected to any risk or only subjected to the lowest possible level of risk.   

The use of medical devices is associated with certain risks. These are higher with some medical devices than others. For example, the use of a pacemaker is associated with higher risk than that of a plaster.

Medical devices associated with higher risks are subject to stricter testing regulations than those associated with a low risk. Manufacturers are therefore obliged to divide their medical devices into different risk classes.

There are four risk classes available: I, IIa, IIb and III. Class I indicates the lowest risk and class III the highest risk. In-vitro diagnostic devices – a special subgroup of devices within medical devices – are divided into risk classes A, B, C and D, where A indicates the lowest and D the highest risk.

What are the criteria for categorization? 

The medical device manufacturer must stipulate the risk class in line with certain rules. The greater the risk to patients, the higher the class. Key factors when determining the risk class include the duration and location of use. Devices that are used for longer are usually associated with a higher level of risk. Devices used in the body are also associated with a higher risk than those used on undamaged skin.

Examples for division into risk classes 

Class I (low risk): 

• Plasters 
• Walking aids 
• Some digital health applications (DiGA)

Class IIa (medium risk):  

• Hearing aids 
• Ultrasound equipment 
• Dental crowns 

Class IIb (medium-high risk):

• Infusion pumps 
• X-ray machines 
• Condoms  

Class III (high risk or life-preserving function): 

• Pacemakers 
• Artificial limbs 
• Breast implants

The responsibilities for medical devices in Germany and the European Union are governed by various laws and regulations: 

• The European Medical Device Regulation (EU) 2017/745 (MDR) forms the basic framework.  
• The German Medical Device Law Implementation Act (MPDG) implements and complements the MDR in Germany.  

Certain federally authorized testing bodies such as TÜV and DEKRA are responsible for tasks associated with the testing and certification of medical devices. The responsible authorities in each federal state monitor the manufacturers and medical devices.

The Federal Institute for Drugs and Medical Devices (BfArM) is primarily responsible for the scientific evaluation of risks associated with medical devices. This includes: 

• receiving reports on serious incidents and subsequently creating risk assessments 
• approving clinical and performance evaluation trials  
• taking decisions on the delimitation and classification of medical devices  
• offering advice to the responsible authorities, the people responsible for bringing the device to market, sponsors and federally authorized testing and inspection bodies 

BfArM also decides whether digital health applications (DiGA) are included in the public DiGA directory so their costs are refunded by health insurance providers.

Who is responsible for in-vitro diagnostic devices? 

In-vitro diagnostic devices (IVD) are a subgroup of medical devices: They are tests that use biological samples such as blood or saliva to determine the condition of a person’s health. Examples include self-tests such as home pregnancy tests or COVID self-tests. However, they also include more complex tests that have to be conducted in a laboratory.

A special legal basis exists for in-vitro diagnostic devices: the European IVD Regulation.

The responsibility for this is divided between the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). The relevant authorities in each of the federal states are responsible for monitoring. 

Further information on medical devices can be found on the website of the Federal Institute for Drugs and Medical Devices (BfArM) – in both the public area and the area for specialists.