Everything You Need to Know About EUDAMED: Preparing for the New Medical Device Regulation
EUDAMED is the EU medical device database that came into effect in May 2021. The regulation, known as MDR (Medical Device Regulation), replaces the Medical Devices Directive (MDD) and sets new standards for medical device registration and market surveillance. It is significantly more stringent when it comes to regulating medical devices. If you are a manufacturer of medical devices, you need to be prepared for EUDAMED access.
The European Databank on Medical Devices is a database that will track all medical devices sold in the EU, and manufacturers will need to register their devices with EUDAMED.
In this blog post, we will discuss EUDAMED – what it is, how to prepare for it, and what changes you can expect. Stay tuned for more information about EUDAMED!
What is EUDAMED?
The European Databank on Medical Devices, or EUDAMED for short, is a secure web-based portal that allows national authorities and regulatory bodies from across the continent to exchange information. This can be done in order to strengthen market surveillance while also ensuring transparency with regards to medical devices being placed onto the markets by making it easier if anyone wants access!
The portal cannot be accessed by customers but instead acts as an exchange between national competent authorities who are required by law to share information thereupon while also helping regulate things like safety standards across borders within Europe!
EUDAMED will also contain important information for those who are involved in medical device clinical trials as well as post-market surveillance.
What are the Benefits of EUDAMED?
From a manufacturer’s perspective, having a centralized database will reduce the amount of paperwork that is needed to be filed in order to market devices across multiple countries within Europe. In other words, it eliminates redundant processes and makes things more efficient!
It will also help improve patient safety as authorities will be able to track devices and their unique identifiers (UDI) more easily, which can lead to quicker identification and recall of faulty products. In addition, patients will be able to access information about recalled devices through UDI numbers too so that they can make an informed decision should they need to!
Players Involved in EUDAMED
The European Commission is the main player when it comes to EUDAMED as they are responsible for setting up and maintaining the database. Other players include:
- Notified Bodies: These are organizations that have been accredited by the European Commission in order to assess whether medical devices comply with the requirements of EU Directives or Regulations.
- Competent Authorities: These are national authorities responsible for ensuring that medical devices placed on their market meet all applicable legal requirements. In addition, they also carry out market surveillance activities to verify compliance!
- Manufacturers: They are required to register their devices with EUDAMED and obtain a Unique Device Identification (UDI) number for each product.
- Authorized Representatives: They act on behalf of the manufacturer and are responsible for ensuring that all medical devices placed onto the market comply with EU law.
- Patients: They have a right to access information about recalled devices through UDI numbers.
Manufacturers of medical devices need to take certain steps in order to prepare for EUDAMED access. These include:
- Actor Registration: EUDAMED actor registration is the process of registering an organization or individual in the EUDAMED database. This is necessary in order to be able to access certain features of the portal, such as submitting applications for clinical trials or placing devices on the market.
- Unique Device Identification (UDI) and Device Registration: Include a UDI on all medical devices placed on the market. The EUDAMED UDI/device registration module is a centralized EUDAMED database that contains information about every medical device with a UDI that is placed on the market in Europe.
- Notified Bodies and Certificates: Medical devices must comply with safety and performance standards set out by the EUDAMED regulation. Certificates issued by notified bodies are recognized throughout Europe.
- Clinical Investigations and Performance Studies: Clinical investigations must be conducted in accordance with EU Clinical Investigation Requirements. This includes performance studies that are conducted to demonstrate the safety and performance of a medical device. Clinical Evaluation information also includes that information.
- Vigilance and Post-market Surveillance: Medical devices are subject to post-market surveillance requirements. This includes monitoring for adverse events and complaints, as well as product recalls.
- Market Surveillance: Competent authorities carry out market surveillance activities to verify compliance with EU medical device requirements.
MDR is a complex regulation that will have a significant impact on the medical device industry. Manufacturers need to start preparing now to ensure they are compliant when the regulation goes into effect.
Understanding EUDAMED Database Search Functionality
EUDAMED is a powerful tool for manufacturers, notified bodies, and competent authorities. It provides extensive search functionality that allows users to easily find the information they need.
The EUDAMED database is searchable by:
- device type
- manufacturer name
- authorized representative name
- Notified Body number
- UDI number
Each of these fields can be used to conduct a simple or advanced search. A simple search will return all results that match the exact search term entered. An advanced search allows you to specify additional criteria, such as product type or date range. This will return targeted results that are more likely to be relevant to your needs.
What is stored in EUDAMED?
EUDAMED stores a variety of information, including:
- Information on Clinical Investigations
- A copy of ISO certificate/Proof of QMS
- Justification of the classification according to Annex IX
- Labeling and instructions
- A vigilance and traceability system or an ISO certificate
- Declaration of conformity
- The registration of manufacturers, the devices in question, and their Authorized Representative
- Any additional documentation
EUDAMED also stores information about clinical investigations and performance studies. This includes data on study design, methodology, and results. Manufacturers must submit this information when they apply for CE Marking of their devices.
The database is updated regularly with new information on clinical investigations and performance studies. Manufacturers should make sure they are familiar with the EUDAMED database search functionality so they can quickly find the information they need.
The MDR regulation is a complex piece of legislation that will have a significant impact on the medical device industry. Manufacturers need to start preparing now to ensure they are compliant when the regulation goes into effect. Understanding EUDAMED database search functionality is essential for manufacturers who want to be able to quickly find the information they need. EUDAMED access will allow you to consult related EUDAMED MDR information.
You may go back to our EU MDR guide.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for European medical device registration.