Medical Device Regulation (“Regulation”) has been published in the Official Gazette numbered 31499 on 2 June 2020.
With the Regulation prepared in accordance with the EU Medical Device Regulation numbered 2017/745 (“MDR”), it is aimed to provide a safer use for manufacturers and medical device users with a transparent and sustainable system.
In this context; new noteworthy provisions are the definition of a medical device, classification of products, distance sales, manufacturer, importer and distributor liabilities in placing products on the market, the EUDAMED system, clinical research in medical devices, notified bodies.
In order to provide a transition period for the new regulations introduced by the Regulation, various effective dates have been foreseen for several articles in accordance with the EU transition process.
i. Medical Device Definition, Classification of Products and Risk Classes
The definition of “medical device” now includes detailed description.
- Devices having purpose of providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and
- Products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in the definition.
have also been defined as medical devices.
The Regulation once again qualifies medical devices in 4 different risk classes (class I, IIa, IIb and III). However, classification amendments are stipulated for certain devices with new regulations made in the classification rules. In particular, the variation of the risk class of some Class I medical devices will require notified body inspection and EC certificate in the new period.
The application procedure to the European Union Commission has been organized by the Turkish Medicines and Medical Devices Agency (“the Agency”) in order to clarify the regulatory status of the products on the borderline, in the evaluation to be made as to whether the products fall within the scope of the definition of medical devices.
ii. Remote and Distance Sales
Under Article 6 of the Regulation, it has been regulated that medical device shall be offered by means of “information society services”. However, no definition is provided for information society services in the Regulation. In the relevant Article of the MDR, a reference is made to another EU legislation (EU Directive 2015/1535) regarding the definition of "information society services"; however, there is no parallel regulation in Turkish law.
Therefore, one can say that there is a grey area in the legislation regarding the channels through which remote and distance sales can be conducted. However, the EU legislation, to which the regulation in Turkey was prepared in parallel, defines the information society service as “sent initially and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means”.
The Agency has not published any announcement yet, on how this article shall be interpreted together with the regulations regarding the sales on the internet regulated by the Regulation on Medical Device Sales, Promotion and Advertising.
iii. Liabilities of Exporter-Importer-Distributor, Person Responsible for Regulatory Compliance and Authorized Representative
The liabilities of exporter, importer and distributor of medical devices have been separately regulated in detail in the Regulation. However, there is no regulation whether the sales centres defined as the place where the devices are sold in the Regulation on Medical Device Sales, Promotion and Advertising, fall in the group of manufacturers, importers and/or distributors.
In addition, if the manufacturer of the medical device is not located in Turkey or EU member countries, the device can only be placed on the market provided that an authorized representative is appointed in Turkey.
Manufacturers are required to have at least one person in charge of regulatory compliance, who is called “person responsible for regulatory compliance”, with the necessary expertise in the field of medical devices, within their organization. There is no regulation as to whether the person responsible for regulatory compliance can be the same person as the "responsible person" regulated in the Regulation on Medical Device Sales, Promotion and Advertising.
iv. European Union Database on Medical Devices (EUDAMED)
In order to improve transparency and increase traceability in the medical device industry, the EUDAMED system of the European Union Commission has been included in the Regulation in accordance with the MDR. In this context, the purposes of registration and the information to be registered are regulated. In addition, it has been regulated that the obligations on the Product Tracking System (“ÜTS”) will continue. The EUDAMED system, which will be open to the public, will be ready for use in six months after its publication in the Official Journal of the European Union and a notice that its functional specifications are met.
When we look at the data that are required to be registered in EUDAMED, notifications containing patient data such as single device tracking and adverse event report will be made through publicly available EUDAMED, and therefore personal data will be processed and recorded through EUDAMED. This data will be processed by Turkey and EU member states, notified bodies, economic operators and sponsors.
In addition, by inclusion of a special disposition regarding the protection of personal data, it is also regulated that the Law on the Protection of Personal Data and other legislation on the protection of personal data will also be applied.
When considered within the scope of the Law on the Protection of Personal Data, since with the EUDAMED notifications, it is required to both collect and process health data and transfer these data abroad, explicit consent of the patients will be required. The issue of obtaining explicit consent and informing the relevant persons beforehand may create difficulties in practice. From the perspective of the EU, the data in the EUDAMED will also be transferred to Turkey.
v. Clinical Evaluation
Detailed regulation on clinical trials of medical devices is included in the Regulation. However, since the Regulation on Clinical Trials of Medical Device is currently in force and has not been abolished by the Regulation, a disposition is required regarding which of these two competing regulations will be taken into account.
vi. Notified Bodies
The Regulation introduces more control and monitoring by the Agency and the EU Commission, the EU executive body, and stricter conditions for the appointment of Notified Bodies. Notified Bodies are organizations assigned to assess the conformity of medical devices with the applicable fundamental technical requirements before placing on the market.
The evaluation of conformity assessment bodies that apply appointment as a notified body will be carried out by the "joint assessment team" consisting of the Agency, the EU Commission representatives, and the representatives of the assignment authorities of two different EU member states. The Agency has already started to accept the Notified Body applications.
The conformity assessment bodies appointed by the Agency are notified to the EU Commission band EU member states by the Ministry of Commerce through NANDO, the EU Notified Bodies Information System and unless an objection is raised, the notification is published on NANDO within 42 days as of the notification.
An announcement has been published by The Agency on 26 May 2021 regarding how long the current EC certificates will be valid. During this transition period, manufacturers should start cooperating with Notified Bodies to plan the new certification schedule for their medical devices and the availability of the Notified Body, the additional data need on devices and the transitional provisions in the Regulation should be taken into consideration.
The Regulation entered into force on the same date as the MDR, to which it is compatible to; and industry stakeholders are guided by announcements of the Agency to ensure compatibility with all EU practice.
While it was necessary to plan the compatibility with the MDR in the preparation of the Regulation, it is observed that not all of the other regulations in force in Turkey are taken into account. Although the implementation of the Regulation will become clear with the announcements published by TITCK, it is expected that other Turkish regulations of TITCK will also be updated in line with EU legislation.