After the long-awaited Regulation on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has entered into force, Medical Device Regulation (“Regulation”) which has been designed following MDR, has been published in the Official Gazette numbered 31499 on June 2 2020. Various effective dates have been foreseen for several articles in accordance with the EU transition process to provide a transition period for the new regulations introduced by the Regulation.
In this context, new noteworthy provisions are the definition of a medical device and classification of products and distance sales, manufacturer, importer and distributor liabilities in placing products on the market, the EUDAMED system, clinical research in medical devices, notified bodies.
Primarily, the Regulation qualifies medical devices in 4 different risk classes (class I, IIa, IIb and III). However, classification amendments are stipulated for specific devices with new regulations 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.
Besides, the liabilities of manufacturer, importer and distributor of medical devices have been separately regulated in detail in the Regulation. However, there is no regulation whether the sales centres are defined as where the devices are sold in the Regulation on Medical Device Sales, Promotion and Advertising, fall in the group of manufacturers, importers or distributors.
Manufacturers are required to have at least one person in charge of regulatory compliance within their organisation, called the “person responsible for regulatory compliance”, with the necessary expertise in the field of medical devices. There is no regulation as to whether the person responsible for regulatory compliance can be the same as the “responsible person” regulated in the Regulation on Medical Device Sales, Promotion and Advertising.
The EUDAMED system of the European Union Commission has been included in the Regulation under the MDR to improve transparency and increase traceability in the medical device industry. In this context, registration purposes and the information to be registered are regulated. In addition, it has been held 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 publication in the Official Journal of the European Union and a notice that its functional specifications are met.
Finally, the Regulation introduces more control and monitoring by the TITCK and the EU Commission, the EU executive body, and stricter conditions for the appointment of Notified Bodies. Notified Bodies are organisations assigned to assess the conformity of medical devices with the applicable fundamental technical requirements before placing them on the market. The evaluation of the appointment application of the conformity assessment bodies that apply to be a notified body will be carried out by the “joint assessment team” consisting of the TITCK, the EU Commission representatives, and the representatives of the assignment authorities of two different EU member states. The TITCK has already started to accept the Notified Body applications.
The conformity assessment bodies appointed by the TITCK are notified to the EU Commission and EU member states by the Ministry of Commerce through NANDO, the EU Notified Bodies Information System. Unless an objection is raised, the notification is published on NANDO within 42 days as of the notification. The TITCK published an announcement on May 26 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 existence of the Notified Body. The additional data needed 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, and announcements of the TITCK guide industry stakeholders to ensure compatibility with all EU practices. Nevertheless, 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, and it is expected that other Turkish regulations of the TITCK will also be updated within this context.