Clinical investigations

Although it varies according to the type of study, by the contracted research organization (SAK) authorized by the investigator, sponsor or sponsor in cases where the sponsor is not resident in our country;

• A contract regulating the conditions and principles of the study is signed with a researcher who can carry out the work to be done, take responsibility for the work, is trained in the relevant field and meets the conditions in the legal legislation.
• First of all, all documents (forms, research brochures etc.) required for a clinical investigation are prepared in accordance with the Good Clinical Practices Guide (GCP) and EN ISO 14155 standard according to the type of study, especially the clinical investigation protocol.

See. TITCK Clinical Research Regulations

https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihazda-klinik-arastirmalar

• Application to the ethics committee is carried out.

See. TITCK Ethics Committees List

https://www.titck.gov.tr/dinamikmodul/84

• After the Ethics Committee Approval, Ministry Approval is required for medical device clinical investigation.

Clinical investigation; It can be done in places that are suitable for ensuring the safety of the people on whom the research will be conducted, conducting the research in a healthy way, following up and performing emergency responses when necessary, and having personnel, equipment and laboratory facilities suitable for the qualification of the research. These places can be university hospitals, health practice and research centers of universities, training and research hospitals and private hospitals provided that these centers are coordinating centers.

In the case of Implantable Medical Devices and Class III devices, Clinical Investigations are conducted, except:

• If the device is designed through modifications of a device already placed on the market by the same manufacturer,
• The modified device has been demonstrated by the manufacturer in accordance with Section 3 of the Annex XIV. to be equivalent to the device placed on the market, and this designation has been approved by the Notified Body; and
• Clinical Evaluation of the device placed on the market is sufficient to demonstrate compliance of the modified device with the relevant safety and performance requirements.

In this case; The Notified Body checks that the Post-Market Clinical Follow-up (PMCF) plan is appropriate and includes post-market studies to demonstrate the safety and performance of the device.

However, Clinical Investigation need not be conducted in the situations referred to in paragraph 6;

1. a) In accordance with Directive 90/385/EC or Directive 93/42/EC, which has been placed on the market or put into service in accordance with the law and its clinical evaluation:

• Based on sufficient clinical data and
• Conforms to the relevant product-specific common specifications (OS), if available, for the Clinical Evaluation of such Medical Devices, or

1. b) Clinical evaluation is based on sufficient clinical data, and if available, the relevant product-specific common specifications (OS) in the appropriate suture, (surgical suture), staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

A Medical Device Manufacturer who demonstrates that his device is equivalent to a device already placed on the market and not manufactured by the manufacturer, may consider paragraph 4 as a basis for not performing a Clinical Trial, provided that, in addition to the requirements in paragraph 4, the following conditions are met:

• The two manufacturers have a valid contract that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis and
• The Original Clinical Evaluation was carried out in accordance with the requirements of this regulation,

The manufacturer of the second device shall provide the Notified Body with clear evidence thereof.

A sponsor is any person, company, institution or organization that takes responsibility for initiating, managing and funding a clinical trial.

It should be possible for both the manufacturer and another natural or legal person to be supportive by taking responsibility for the clinical investigation.

It is not possible to predict the Clinical Investigation Period for any Medical Device. However, after the approval of the Ethics Committee and the Competent Authority (Ministry of Health), the study and observation periods to be determined by methods such as Statistical analysis carried out in Clinical Research Centers are taken as a basis.

• Initial Application Fee
• Fee to be charged by Clinical Research Institutes
• Insurance Fees of Voluntary Patients

See. TİTCK Clinical Research Application Fees

https://www.titck.gov.tr/dinamikmodul/70

Recruitment of volunteer patients is the responsibility of the Supporter.

Member States shall ensure that systems of compensation for harm sustained by a subject due to participation in a Clinical Investigation conducted within their territory are in place in the form of insurance, form of assurance or similar agreement that is equivalent in purpose and appropriate to the nature and extent of the risk (MDR Article 69)

No. Clinical Investigation is not mandatory for Medical Devices certified from the current MDD, especially if sufficient clinical evidence is provided from a robust PMS Process that includes the PMCF process.