Medical Device Regulation and In vitro Diagnostic Medical Device Regulation introduce new practices and obligations in order to ensure product safety. Therefore, the Circular on Medical Devices numbered 2022/1 (“Circular”) has been published in order to effectively implement the said Regulations and to clarify the issues regarding the newly introduced applications in these matters for informing the sector.
As Günbay Kural Abbasoğlu Law Firm, we would like to inform our clients regarding the future practices by examining the important regulations within the scope of the Circular.
Obligation to employ at least one employee as the “legislative compliance officer”:
- In line with the regulations, manufacturers specified in the Medical Device Regulation and the In vitro Diagnostic Medical Device Regulation, are obliged to employ at least one person as a "compliance officer" within their organization.
- Micro and small business/manufacturers, which do not employ a full-time legislative compliance officer, are obliged to hire a person(s) having the same qualifications or to outsource such services on a permanent and constant basis from an organization that employed such person(s), within the scope of the terms stipulated under the Circular.
- Authorized representatives are also obliged to receive this service permanently and continuously from at least one person whose qualifications are specified in the regulations within the scope of the terms regulated in the Circular.
- Manufacturers are obliged to register the contact information of the assigned personnel with the Product Tracking System (ÜTS) and the European Commission's European Database on Medical Devices (EUDAMED) and to keep this information up to date.
The obligation of registration notification to EUDAMED:
- Organizations operating as manufacturers, importers, authorized representatives and systems and transaction package producers within the scope of the regulations are obliged to have an actor registration in EUDAMED. In addition, medical devices supplied to the market by such organizations are required be registered via the UDI module of EUDAMED.
- Accordingly, the obligations and requirements relating to EUDAMED will be effective from the date corresponding to six months after the publication date of the notification regarding the full functionality of EUDAMED.
Obligation for importers and distributors in matters related to labeling and repackaging of medical devices:
- Distributors or importers who want to make a device available on the market by translating and relabeling its original label, are obliged to fulfill the specified requirements.
- Distributors or importers who want to supply to the market or make available on the market a device whose end users are only a healthcare professionals can keep the label on the device or its packaging in one of the EU official languages, provided that the necessary and accompanying documents are provided in Turkish.
Lastly, certain changes are stipulated within the scope of the Circular in order to reduce the burden of unnecessary applications made at ÜTS and to ensure that the registration applications are made in accordance with the provisions of the regulations.
Issues regarding the ÜTS system within the scope of the Circular will be announced by the Authority with the announcement to be made after the relevant parts of the ÜTS are activated.
In case you require further information, you may contact Günbay Kural Abbasoğlu Law Firm lawyers.