While debates related to clinical research and its legal foundations within Turkey continues, a special regulation has been issued pertaining to Medical Device clinical research. With the path opened through this regulation, Turkey is foreseen to be a continuously developing white hope market.
The 2008 dated Regulation Pertaining to Clinical Researches, which has become subject of a lawsuit upon objections of Turkish Medical Association ("TMA"), also included clinical researches made with medical devices, and as the mentioned regulation is still in effect as result of the lawsuit process, no change with regard to the coverage of this regulation has occurred.
On the other hand, the arguments set forth within the above mentioned lawsuit forced the lawmaker to enact a law regarding clinical researches and by way of adding an article to the Principal Law on Health Services on April 6, 2011 the general frame of clinical researches is drawn with a legal text. This Additional Article 10 also covers researches made with clinical devices.
Following those developments, a special provision regarding medical device clinical researches is included within the Medical Device Regulation which has come into effect by being published on the Official Gazette dated June 07, 2011; Article 15 of the Regulation is on medical device clinical researches. This new regulation has been issued in order to harmonise the national regulation with the 93/42/EEC Directive, by exactly adopting the principles within the directive. With the said article, different regulations than all other clinical researches that are in scope of the Regulation Pertaining to Clinical Researches are foreseen for medical device clinical researches. In line with these specific provisions, a requirement to inform the European Union Commission has been introduced in cases such as refusal, cease, suspension, significant alteration demand, and early termination of medical device clinical researches. In such way, the medical device researches are maintained to be monitored in an international platform.
Issuance of new rules for medical device clinical researches, while the Regulation Pertaining to Clinical Researches including medical devices is still in force, may lead to problems and the solution of these problems in practice will require proper legal analysis to be conducted with the guidance of the implementers. However, Turkey's willingness and objective to attract research and development projects and to transfer know-how and technology from developed countries is generally considered as a moving spirit for solving such problems.
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