Healthcare & Life Sciences Newsletter - September 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published i) the Regulation on the Reclassification of Certain Active Non-Medical Product Groups and ii) the Guideline on the Implementation of the Provisions of the Regulation on Technical Services for Medical Devices Used for Provision of Medical Services.

The TİTCK also amended i) the Medical Device Regulation, ii) the In Vitro Diagnostic Medical Device Regulation and iii) the Guideline on the Scheduling of Marketing Authorization Applications for Pharmaceuticals.

Regulation on the Reclassification of Certain Active Non-Medical Product Groups

On 17 August 2024, the TİTCK published the Regulation on the Reclassification of Certain Active Non-Medical Product Groups. The Regulation reclassifies certain active nonmedical product groups, set out in Annex XVI of the Medical Device Regulation, aligning with the Commission Implementing Regulation (EU) 2022/2347 dated 1 December 2022 on the reclassification of certain active nonmedical product groups, which introduces rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council dated 5 April 2017. The main amendments introduced by the Regulation are as follows:

- Equipment intended for use to reduce, remove or destroy adipose tissue shall be reclassified as class llb.

- High-intensity radiation-emitting equipment that is intended for use on the human body for skin treatments shall be reclassified as class llb. However, if the relevant equipment is solely intended for hair removal, it shall be classified as class lla.

- Equipment used for brain stimulation, applying electrical currents, and magnetic or electromagnetic fields penetrating the skull to modify neuronal activity in the brain shall be reclassified as class III.

The Regulation is available here (in Turkish).

Medical Device Regulation

On 17 August 2024, the TİTCK published the Regulation Amending the Medical Device Regulation. The main amendments introduced by the Regulation are as follows:

- As of 10 January 2025, where a manufacturer anticipates an interruption or a suspension of the supply of a device, other than custom-made devices, and where it is reasonably foreseeable that this interruption or suspension could result in serious harm or a risk of serious harm to patients or public health in Türkiye or EU Member States, the manufacturer shall inform the TİTCK, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or suspension. Excluding exceptional circumstances, such information shall be provided at least 6 months before the anticipated interruption or suspension, and the reasons for the interruption or suspension must be specified in the information the manufacturer provides to the TİTCK.

- A full reassessment shall be carried out 5 years after the notification of the conformity assessment body (notified body) and every 5 years after that to determine whether it still meets the requirements set out in Annex VII of the Regulation.

- The obligations and requirements regarding any of the electronic systems that EUDAMED involves — i.e., i) the electronic system for registration of devices, ii) the UDI database, iii) the electronic system for the registration of economic operators, iv) the electronic system for notified bodies and certificates, v) the electronic system for clinical research, vi) the electronic system for vigilance and postmarket surveillance and vii) the electronic system for market surveillance and inspection — will enter into force 6 months from the publication date of the notice in the Official Journal of the European Union regarding whether the relevant electronic system is functional and meets the functional specifications.

- The coordinated assessment for clinical research will enter into force 5 years from the publication date of the notice in the Official Journal of the European Union regarding whether the relevant electronic system is functional and meets the functional specifications.

The Regulation is available here (in Turkish).

In Vitro Diagnostic Medical Device Regulation

On 17 August 2024, the TİTCK published the Regulation Amending the In Vitro Diagnostic Medical Device Regulation. The main amendments introduced by the Regulation are as follows:

- As of 10 January 2025, where a manufacturer anticipates an interruption or a suspension of the supply of a device, and where it is reasonably foreseeable that such interruption or suspension could result in serious harm or a risk of serious harm to patients or public health in Türkiye or EU Member States, the manufacturer shall inform the TİTCK, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or suspension. Excluding exceptional circumstances, this information shall be provided at least 6 months before the anticipated interruption or suspension, and the reasons for the interruption or suspension must be specified in the information that the manufacturer provides to the TİTCK.

- A full reassessment shall be carried out 5 years after the notification of the conformity assessment body (notified body) and every 5 years after that to determine whether it still meets the requirements set out in Annex VII of the Regulation.

- Certificates issued by notified bodies in accordance with the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro), which was repealed on 25 May 2017, and that were still valid on 26 May 2022 and not withdrawn after that, will remain valid until 31 December 2027. However, the expiration date specified in the certificate may be earlier. Certificates that were still valid on 26 May 2022 and expired before 9 July 2024 will only be considered valid until 31 December 2027 if one of the following conditions is met:

- Before the expiry date of the certificate expires, a written agreement has been signed between the manufacturer and the notified body pursuant to paragraph 2 of Article 4.3 of Annex VII of the Regulation for the conformity assessment of the device covered by the expired certificate or a device intended to replace it.

- The TİTCK has accepted an exception to the applicable conformity assessment procedure pursuant to Article 56(1) of the Regulation or has requested that the manufacturer undertake the applicable conformity assessment procedure pursuant to Article 91(1) of the Regulation.

- Devices with a valid certificate issued pursuant to the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro) can be placed on the market or put into service until 31 December 2027.

- Devices with conformity assessment procedures that do not require the involvement of a notified body, pursuant to the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro) and a conformity declaration issued before 26 May 2022, and devices with conformity assessment procedures that require the involvement of a notified body, pursuant to the Regulation, can be placed on the market or put into service until the following dates:

- Until 31 December 2027 for Class D devices

- Until 31 December 2028 for Class C devices

- Until 31 December 2029 for Class B devices and for Class A devices placed on the market in sterile condition

- The abovementioned devices can only be placed on the market or put into service until the relevant dates if the following conditions are met:

- The devices continue to comply with the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro).

- No significant change exists in their design and purpose of use.

- The devices do not pose an unacceptable risk to the health or safety of patients, users and others, as well as to other matters of public health protection.

- By 26 May 2025, the manufacturer implements a quality management system pursuant to the Regulation.

- The manufacturer or the authorized representative makes a formal application for a conformity assessment or for a replacement of the device to a notified body by the following dates at the latest:

– Until 26 May 2025 for devices with a valid certificate issued pursuant to the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro) and for Class D devices

– Until 26 May 2026 for Class C devices

– Until 26 May 2027 for Class B devices and for Class A devices placed on the market in sterile condition

- The notified body and the manufacturer sign a written agreement by the following dates at the latest:

– Until 26 September 2025 for devices with a valid certificate issued pursuant to the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro) and for Class D devices

– Until 26 September 2026 for Class C devices

– Until 26 September 2027 for Class B devices and for Class A devices placed on the market in sterile condition

- The notified body issuing the certificate is responsible for appropriate surveillance regarding the applicable requirements for the devices it certifies, unless the manufacturer has agreed with a designated notified body.

- The notified body signing a written agreement shall be responsible for the surveillance of the devices covered by the written agreement until 26 September 2025, at the latest. If the written agreement covers a device intended to replace a device with an issued certificate pursuant to the repealed Regulation on Medical Diagnostic Devices for Outer Body Use (In Vitro), surveillance shall be carried out for the replacing device.

- The obligations and requirements regarding any of the electronic systems that EUDAMED involves — i.e., i) the electronic system for registration of devices, ii) the UDI database, iii) the electronic system for registration of economic operators, iv) the electronic system for notified bodies and certificates, v) the electronic system for performance studies, vi) the electronic system for vigilance and postmarket surveillance and vii) the electronic system for market surveillance and inspection — will enter into force 6 months from the publication date of the notice in the Official Journal of the European Union regarding whether the relevant electronic system is functional and meets the functional specifications.

- The coordinated assessment for performance studies will enter into force 5 years from the publication date of the notice in the Official Journal of the European Union regarding whether the relevant electronic system is functional and meets the functional specifications.

The Regulation is available here (in Turkish).

Guideline on the Implementation of the Provisions of the Regulation on Technical Services for Medical Devices Used for Provision of Medical Services

On 21 August 2024, the TİTCK published the Guideline on the Implementation of the Provisions of the Regulation on Technical Services for Medical Devices Used for Provision of Medical Services. The main amendments introduced by the Guideline are as follows:

- Real or legal persons that wish to obtain a technical service activity certificate and that meet the conditions described in the Regulation on Technical Services for Medical Devices Used for Provision of Medical Services (“Regulation”) and the Guideline must apply electronically via the Product Tracking System (“ÜTS”).

- If there are no deficiencies in the application upon payment of the application fee, the applicant will be notified of the date of the on-site inspection, if deemed necessary by the TİTCK. The applicant must pay the on-site inspection fee at least 3 business days prior to the date of the on-site inspection.

- If any deficiency is identified in the application, the applicant will be notified of the relevant deficiencies in writing. If the applicant is notified of existing deficiencies in the application, they shall submit corrections to these deficiencies to the TİTCK via the ÜTS within 45 business days at the latest.

- If the deficiencies identified by the TİTCK during the authorization process are not remedied within the given period, the application will be canceled and the payments previously made to the TİTCK regarding this application will not be refunded.

- As of 1 January 2026, technical service activities for group A, B and C devices will only be carried out by the technical services authorized under the Regulation.

- The private service or the service that will carry out the technical service activities abroad if there is no technical service within the country will not be able to carry out these activities without a signed/certified document issued by the manufacturer or importer of the relevant device stating that it can perform modification, update and upgrade activities.

- For a malfunction occurring in the device under warranty to be considered as misuse, the rule regarding the misuse must be included in the user manual, which must be registered in the ÜTS.

- The technical service must prepare a technical service report, which is to include the results of the technical service activity performed, in accordance with the Guideline.

- The inspection that the TİTCK must carry out upon complaint or ex officio shall start with the official letter to be received by the technical service to be inspected. If deemed necessary by the TİTCK, it can also be carried out as an unannounced instant inspection.

The Guideline is available here (in Turkish).

Guideline on the Scheduling of Marketing Authorization Applications for Pharmaceuticals

On 29 August 2024, the TİTCK updated the Guideline on the Scheduling of Marketing Authorization Applications for Pharmaceuticals. The main amendments introduced by the Guideline are as follows:

- Following the assessment of all applications (initial and revised ones) made in the month prior to the calendar month according to the order of application date, the pharmaceuticals that were found to be appropriate in the preliminary assessment shall be included in the scheduling list.

- A hybrid product group is also included within the scope of the Guideline. In this regard, 5 applications for the hybrid product group that were found to be appropriate in the preliminary assessment will be included in the scheduling list.

The Guideline is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.