As it is known, the “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation” are in force in Turkey in parallel with the regulations in the European Union (“EU”) legislation. With the announcement shared by The Turkish Medicines and Medical Devices Agency (“TMMDA”) on 11.10.2024, the “Draft Communiqué on the European Database on Medical Devices” (“Draft Communiqué”) was prepared and opened to public opinion. In this context, the Draft Communiqué aims to align the Draft Communiqué with the Commission Implementing Regulation setting out the rules for the implementation of Regulation (EU) 2017/745 on the “European Database on Medical Devices (”Eudamed“)” recently published by the European Commission within the scope of harmonization with EU Legislation.
In this article, we have summarized the main regulations introduced by the Draft Communiqué.
Type of Access to EUDAMED
The actors that can access the Eudamed system are regulated in Article 5 of the Draft Communiqué. Accordingly, a binary distinction is made as institutions and authorized bodies and other actors other than these.
Institutions and Authorized Bodies: Institutions and authorized bodies can access Eudamed through machine-to-machine data exchange.
Other Actors: Actors other than institutions and authorized bodies may also request access through this method under certain conditions.
Registration and Access to Eudamed through the Restricted Site
Registration Process: Natural persons need to create an account through the Commission's authentication service “EU Login” in order to be granted access to Eudamed via the restricted site.
First User-First User Information: Turkey shall inform the Commission so that the Authority can be registered as the qualified authority and the first authorized user can access the restricted site.
Actor Registration: Actor applicants must submit an actor registration request via Eudamed's website (Restricted Internet Request) , which is accessible by authorized users. This request must include a signed declaration of the required information security responsibilities. When evaluating this request, the Agency will take into account whether it is related to clinical trials or performance studies. Once the registration has been accepted ,the person who first enters the details of an actor in EUDAMED automatically be granted access to the restricted site and becomes the first authorized user.
Registration Requirements: If the actor candidate is resident in Turkey or the authorized representative of the manufacturer resident outside Turkey and EU Member States is resident in Turkey, the Authority shall be designated as the National Competent Authority.
Request for Access: Natural persons may request access to the restricted site to act on behalf of an actor. This request must be approved by the actor's LAA (Local Actor Administrator) or LUA (Local User Administrator). The person who first enters the details of an actor in EUDAMED automatically becomes the LAA for that actor. While Local Actor Administrator (“LAA”) refers to an authorized user with the right to manage certain information regarding the details of an actor and to grant access to Eudamed through the restricted site to other natural persons acting on behalf of that actor; Local User Administrator (“LUA”) refers to an authorized user with the right to grant access to Eudamed through the restricted website to other natural persons acting on behalf of an actor.
Terminology: Authorized users providing information to Eudamed must use European Medical Device Terminology (EMDN) codes.
Technical and Administrative Support: The Commission has established an application support team to provide assistance to users. Users can reach this team through the functional mailbox. Users have access to technical documentation on Eudamed, frequently asked questions and documents supporting machine-to-machine data exchange services.
Personal Data Processing: At Eudamed, the names, contact details and other relevant data of actors and authorized users are processed within the framework of the Medical Device Regulation and In vitro Diagnostic Medical Device Regulation. This is necessary to comply with the regulations.
Malfunction Status: If an actor or authorized user detects a malfunction, they are obliged to notify the Commission immediately. When the Commission detects a malfunction, it notifies the situation and the possible downtime. Data submission deadlines may be suspended due to a failure. The draft sets out different procedures to be followed depending on the duration of these failures. In addition, a separate procedure is also provided in the event of a malfunction that prevents compliance with one of the obligations set out in the Medical Device Regulation or the In vitro Diagnostic Medical Device Regulation. These procedures must be complied with by the actor.
In addition to the mentioned regulations, it is also regulated that tests should be conducted to improve users' interactions with the system before data submission to the system, and that access to Eudamed may be suspended by the Agency when a threat is detected in terms of IT security incidents. Accordingly, when the Agency or users suspect fraudulent requests for access to Eudamed, they should refuse such requests and notify the Commission.
In conclusion, the main purpose of the Draft Communiqué regulating the procedures and principles regarding the implementation of Eudamed is to ensure the safe and effective management of information on medical devices and in vitro diagnostic medical devices. In this context, the Draft Communiqué aims to increase the transparency of the system by clearly defining the data registration and access processes of users and includes the necessary regulations to ensure the safe and effective operation of the Eudamed system. The Draft Communiqué will be open for public comment until 25.10.2024.