Turkey Regulated Medical Devices Manufactured Utilising Tissues of Animal Origin
Turkey has recently issued the Regulation on Medical Devices Manufactured Utilising Tissues of Animal Origin (Regulation”) with the purpose of harmonization with the European Union legislation. With this respect, the Regulation was grounded on the European Commission Regulation Numbered 722/2012 concerning requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin.
As per the Regulation, it is aimed to regulate the requirements regarding the placing on the market and/or putting into service of medical devices manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue including active implantable medical devices. Accordingly, bovine, ovine and caprine species, deer, elk, mink and cat tissues and their derivatives are under the scope of the Regulation provided that collagen, gelatine and tallow used for the manufacturing of medical devices meet the minimum requirements for human consumption stipulated under the relevant legislation. The medical devices which are not intended to contact with the human body or which are intended to come into contact with intact skin only and the tallow derivatives processed under certain conditions at least as vigorous as those stipulated under the Annex 1 of the Regulation are exempted from the scope of the Regulation.
Pursuant to the Regulation, the manufacturer of the abovementioned medical devices or their authorized representative is required to make the risk analysis and implement the risk management plan prior to filing an application for conformity assessment pursuant to the Regulation on Medical Devices or the Regulation on Active Implantable Medical Devices. In this regard, additional conformity requirements are stipulated concerning custom-made devices and devices intended for clinical investigation that are under the scope of the Regulation.
Accordingly, conformity to the general requirements under the Regulation on Medical Devices or the Regulation on Active Implantable Medical Devices as well as the special requirements under the Regulation shall be assessed by the notified bodies which shall maintain the required up-to-date knowledge and expertise pursuant to the Regulation.
To verify that the benefits of the device outweigh the residual risks, notified bodies evaluate the documentation provided by the manufacturer especially taking into account:
- the manufacturer’s risk analysis and risk management process;
- the justification for using animal tissues or their derivatives, considering low-risk tissues or synthetic alternatives;
- the results of elimination and inactivation studies or results of relevant literature analysis;
- control of the manufacturer regarding raw material resources, finished products, production process, tests, and contractors; and
- the requirement to inspect matters relating to the sourcing and p processing of animal tissues and derivatives and elimination or inactivation of pathogens including those carried out by the supplier.
With this respect, notified bodies, if available for starting materials, take the TSE (transmissible spongiform encephalopathies) conformity certificate issued by the European Directorate for the Quality of Medicines (EDQM) into consideration during the risk analysis and risk management assessment. Following the assessment process, notified bodies report to the European Commission and other competent authorities regarding their evaluations via Turkish Medicines and Medical Devices Agency (TITCK) before issuing an EC design examination certificate or an EC type examination certificate. The competent authorities of the EU member states give their opinion on this evaluation report within four weeks from the date on which the notified body notifies the Authority regarding the medical devices using starting materials that have the TSE certificate of conformity; and within twelve weeks for those that have not the certificate. After considering such opinions, the notified bodies shall inform the European Commission and the competent authorities of the EU member states through TITCK regarding the reasons not to consider one or more of the opinions received, and final decisions on this matter.
Additionally, pursuant to the Regulation, the manufacturer is obliged to collect, evaluate, and submit the information regarding changes in animal tissue or derivatives used for the medical device or TSE risks associated with the device to the notified body. In case this information leads to an increase in the total TSE risk, the abovementioned procedure of conformity assessment is applied.
Simge Kılıç, Nihan Ünal