Product registration CA | EUDAMED

Prior to placing a medical device or in vitro diagnostic medical device on the market, a registration or notification must be made with the relevant Competent Authority or EUDAMED.

What is the process of notification or registration of the product?

Before placing a medical device or in vitro diagnostic medical device on the market, the marketing entity is obliged to make a notification to the relevant Competent Authority or to the EUDAMED database.

Who is the Competent Authority?

Competent Authority is the government office responsible for the registration and vigilance of the medical devices and in vitro diagnostic medical devices. In Poland, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is the Competent Authority supervising medical devices.

What is EUDAMED?

EUDAMED (European Database on Medical Devices) is a European database of medical devices placed on the market in the European Union. It serves as a crucial tool implemented under Regulation 2017/745 (MDR) and acts as a central channel for the exchange of information between competent authorities and the European Commission.

Who should register in the EUDAMED database?

Entities such as manufacturers, authorized representatives, importers, and producers of systems or procedural kits conducting registered activities in the European Union and countries like Iceland, Liechtenstein, Turkey, or Northern Ireland register in the EUDAMED database. Manufacturers located outside the European Union, Iceland, Liechtenstein, Norway, Turkey, or Northern Ireland can register only if their authorized representative is based in the EU, Iceland, Liechtenstein, Turkey, or Northern Ireland.

Entities eligible for registration submit applications for registration as actors. A registered actor receives a unique identification number – SRN (Actor ID). It’s important to note that a single entity may perform multiple roles simultaneously, such as being both a manufacturer and an importer, requiring separate registration for each role with distinct SRN (Actor ID) numbers.

Structure of the EUDAMED database

EUDAMED consists of six modules:

1. Actors Registration – registration of economic entities.
2. UDI/Device Registration – registration of medical devices and the UDI database.
3. Notified Bodies and Certificates – a database of certificates issued by notified bodies.
4. Clinical Investigation and Performance Studies – a database of information on clinical trials.
5. Vigilance and Post-Market Surveillance – a database of information on observations and post-market monitoring of medical devices.
6. Market Surveillance – a database of information on market surveillance.

EUDAMED also allows information searches by unregistered users through a public website called EUDAMED Public.

What are launch dates for full functionality of EUDAMED modules?

Currently, the first three modules are active:

• Actors Registration – active since December 2020.
• UDI/Device Registration – active since October 2021.
• Notified Bodies and Certificates – active since October 2021.

Registration of entities and medical devices and the entry of data on certificates issued by Notified Bodies are possible. The remaining three modules related to market surveillance (Clinical Investigation and Performance Studies, Vigilance and Market Surveillance) are under development and will be released when EUDAMED is deemed fully operational. The earliest completion date for technical work on the database is the end of 2024.

Final deadlines for requirements related to the EUDAMED database

Registration in the EUDAMED database is not mandatory until it becomes fully operational, and its functional specifications are verified. The completion of work on the EUDAMED database will be announced through a notification published in the Official Journal of the European Union. From the date of notification:

• A 6-month period begins for the registration of actors.
• A 24-month period begins for the registration of devices.

How to create an account in EUDAMED?

Before registering an entity or entering data on medical devices, one must create an account in the EUDAMED database. The account is created by a user who receives an EU Login account linked to the company’s email address. There are various user profiles (e.g., Viewer, Verifier, LUA, LAA) depending on the level of permissions for making changes or granting permissions to other users. Users with the highest access level in EUDAMED are those with LAA and LUA profiles.

LAA (Local Actor Administrator): has permissions for entity registration, actor data management, and possesses the permissions of all subordinate profiles. For example, LAA has LUA permissions to grant access to new users.

LUA (Local User Administrator): approves/updates/removes access requests for users and manages users and their roles. However, LUA cannot update actor (entity) data.

Any user with an EU Login account can request access to a registered actor. A user with granted access can add/update information (depending on the profile) in specific modules such as UDI/Device Registration or Notified Bodies and Certificates.

Registration of an actor (entity) in the EUDAMED database

Before registering an entity in the EUDAMED database, several considerations must be taken into account:

1. Determine the entity’s role (MF-manufacturer, AR-authorized representative, IM-importer, PR-producer of systems or procedural kits).
2. Designate a person responsible for regulatory compliance (OZZR).
3. Conclude a contract with the Authorized Representative (if applicable).
4. Designate LAA and LUA.
5. Fill in the necessary documents/agreements for inclusion in the database.

The registration of an entity (actor) is carried out by a user with an LAA profile who:

• Enters the entity’s data and contact information.
• Includes data on individuals or the person responsible for regulatory compliance.
• Attaches relevant documents and agreements as attachments.

The completed registration is then submitted to the competent authority for verification. Upon successful verification, the entity receives a unique registration number SRN.

Role of UDI in EUDAMED

Introduced by Regulation 2017/745 (MDR), the Unique Device Identification (UDI) system aims to improve the traceability of medical devices, enhance post-market safety activities, and facilitate more efficient market monitoring by competent authorities. Medical devices are registered in the EUDAMED database based on assigned Basic UDI-DI and UDI-DI codes. The Basic UDI-DI code and its counterpart in the EUDAMED database – the EUDAMED DI code, serve as the primary access key linking devices with the same intended use, performance, risk class, and manufacturing method. The UDI-DI code, or EUDAMED ID code in the EUDAMED database, is the main identifier unique to each registered device.

Goal of the EUDAMED database

The main goal of implementing the EUDAMED database is to enhance transparency and coordination in the exchange of information regarding medical devices available in the EU market. EUDAMED is designed to be a multifunctional system, serving as a registration, collaboration, notification, and information dissemination system open to the general public.

Who can report or notify a medical device?

The manufacturer and an authorised representative residing or based in Poland is obliged to submit a medical device and a medical device for in vitro diagnostics. The notification must be made at least 14 days before the first placing on the market.

A distributor or importer residing in Poland is obliged to notify of the intention to introduce a medical device and a medical device for in vitro diagnostics. The notification shall be made not later than within 7 days from the date of placing the first device on the market.