The Turkish Ministry of Health (“the MoH”) has recently shared a Draft Communiqué on the electronic instructions for use (IFU) of medical devices with the industry for comments and suggestions.
It can be seen that the Draft Communiqué is based on the EU Regulation numbered 207/2012 of March 09, 2012 (“EU Regulation”). The Communiqué will have its legal ground based on the Law on the Preparation and Implementation of the Technical Legislation on Products numbered 4703, the Decree-Law numbered 663, the Turkish Medical Device Regulation which is in line with 93/42/EEC and 2007/47/EEC Directives and the Regulation on Active Implantable Medical Devices in line with 90/385/EEC that was amended by 2007/47/EEC.
The Communiqué determines the principles and procedures regarding the application of the electronic IFU on websites. It further regulates the content of these electronic IFU and provides guidance on how to transform from paper to electronic form.
These rules and procedures are indeed parallel to the EU Regulation that the Communiqué is based on. Electronic IFU is permitted only for certain medical devices and accessories which are intended for exclusive use by professional users and not for the use of other persons. These medical devices and accessories are listed under Article 5 of the Communiqué which is in line with Article 3 of the EU Regulation. The articles regarding the risk assessment, the requirements for electronic IFU, the indications regarding the electronic IFU, the website application and the fulfilment of the obligations regulated under the EU Regulation have been translated word for word and incorporated into the document.
We have seen over the years that the MoH have been rigorously following the EU practice and harmonizing current Turkish legislation with all the EU Regulations applicable to medical devices. Therefore, it can be said that the introduction of the electronic IFU for medical devices was not unexpected. However, it can be seen that the MoH has chosen to follow Europe’s timeframe as well. The MoH expects comments and suggestions from the industry until February 16, 2013 upon which it will finalize and publish the Communiqué which will enter into effect upon publication. Since the EU Regulation shall become applicable from March 01, 2013, Turkey expects this new practice to enter into force almost at the same time as the EU.