According to the MDR legislation (Medical Device Regulation), an AED (Automated External Defibrillator) must be considered a medical device and must meet certain requirements in order to be marketed and used in the European Union. The MDR is a European legislation that sets the rules and regulations for medical devices within the European Union (EU). This regulation has been in force since 26 May 2021.
The MDR sets strict requirements for the safety and performance of medical devices to ensure the health and safety of patients and users.
Improved oversight: Stricter control and monitoring mechanisms have been introduced, including improved traceability of medical devices throughout the manufacturing and distribution process.
Here are some general points that a manufacturer and AED supplier must comply with:
CE marking:
An AED must bear a CE mark, which indicates that the product complies with European legal requirements and has been approved for sale within the EU.
Conformity assessment:
The manufacturer must carry out a conformity assessment, including the preparation of technical documentation demonstrating the conformity of the product with the relevant requirements of the MDR.
Quality system:
The manufacturer must implement and maintain a quality system in accordance with the MDR regulations.
Clinical evaluation:
A clinical evaluation should be performed to assess the safety and performance of the AED.
Post-market surveillance:
The manufacturer must monitor the safety and performance of the medical device it sells. Post-market surveillance systems must be in place to monitor the performance of the product after market introduction and report any incidents.
Registration with European databases :
Manufacturers must provide information on their medical devices, including AEDs, to European databases, such as EUDAMED (European Database on Medical Devices).
EUDAMED is a central database containing information on medical devices and manufacturers. It serves as a tool for transparency and oversight.
What does MDR mean for me as a buyer of medical devices?
As a buyer of medical devices, the implementation of the Medical Device Regulation (MDR) within the European Union has several implications and benefits for you:
Enhanced Safety and Performance:
The MDR imposes stricter requirements on manufacturers to ensure the safety and performance of medical devices. This means that the products you buy are likely to meet higher standards.
Transparency and Traceability:
The regulation emphasises the importance of transparency and traceability of medical devices. Information on products, manufacturers and other economic operators must be available and easily accessible.
Registration in European Database:
Manufacturers are required to register relevant information about their medical devices in the European Database for Medical Devices (EUDAMED). Although EUDAMED may not be directly accessible to individual purchasers, it contributes to overarching supervision and transparency in the market.
Improved Incident Monitoring and Reporting:
There are stricter requirements for post-market surveillance and incident reporting. This means that any problems with medical devices are identified and reported more quickly.
Standardization of Labeling and Information:
Medical devices must comply with standardized labeling requirements. This can help you as a buyer understand product information and make informed choices.
Quality of Imported Resources:
Importers must ensure that medical devices they place on the EU market comply with the MDR requirements. This contributes to the quality and conformity of imported devices.
Although the MDR is primarily aimed at manufacturers, authorized representatives, importers, and distributors, as a buyer you will indirectly benefit from the stricter standards and improvements it brings to the medical devices you purchase. However, it is always wise to work with certified and reliable suppliers and healthcare providers when purchasing medical devices to ensure that you receive good quality products that meet your needs.
What should I pay attention to when purchasing an AED?
When purchasing an Automated External Defibrillator (AED) in accordance with the Medical Device Regulation (MDR), there are several aspects to consider to ensure that the device meets the requirements of the MDR. Here are some important considerations:
CE marking:
Check if the AED is provided with a CE mark. This indicates that the product meets the essential requirements of the MDR and is approved for sale within the European Union.
Manufacturer and Identification Data:
Make sure the AED is supplied by a manufacturer that complies with the MDR requirements. Check the manufacturer's identification details and whether they have an authorized representative in the EU.
Technical Documentation:
Ask for the technical documentation of the AED, which contains information on design, performance, clinical evaluation, and other relevant aspects. This documentation is necessary to demonstrate compliance with the MDR.
Conformity assessment:
Verify that the manufacturer has performed a conformity assessment according to the MDR. This process involves demonstrating the product's compliance with the applicable regulations.
Clinical Evaluation:
Ensure that the AED has undergone a clinical evaluation according to the requirements of the MDR. This includes the use of clinical data to assess the safety and performance of the device.
Post-market Surveillance:
Ask about the manufacturer's post-market surveillance system. The MDR requires an active system for monitoring the product after market introduction and reporting any incidents.
Instructions for Use and Labeling:
Ensure that the AED is supplied with clear and understandable instructions for use. The label on the device must comply with the labelling requirements of the MDR.
Registration with EUDAMED:
Although individual purchasers do not need to register directly with EUDAMED, you can inquire whether the manufacturer or authorised representative has registered the necessary information about the AED in the European Medical Device Database (EUDAMED).
By considering these aspects, you can ensure that the AED you are considering purchasing meets MDR requirements and therefore high standards of safety and performance. It is also advisable to work with reputable suppliers and medical equipment experts.
Important dates regarding MDR:
Here are some important dates and events related to the Medical Device Regulation (MDR):
Entry into force of MDR :
The MDR officially entered into force on May 26, 2021.
Transition period:
Manufacturers had until 26 May 2024 to fully comply with the MDR requirements. During this transition period, medical devices that comply with the MDD can still be placed on the market.
Consequences after May 26, 2024:
After 26 May 2024, medical devices that do not comply with the MDR may no longer be placed on the European market.
It is essential to stay informed about any updates, changes and deadlines regarding the MDR, as the regulation is complex and can be adjusted based on new developments. Manufacturers, distributors, healthcare professionals and other stakeholders should regularly check for changes in the regulation and its implementation.
What MDR support can you expect from AEDwijzer?
Compliance Teams:
AEDwijzer has a specific team that is responsible for understanding, implementing and maintaining MDR compliance within the organization.
Training and Education:
AEDwijzer provides training and education to employees on the requirements of the MDR which are essential to ensure that staff are aware of the regulations and how to implement them in their daily work.