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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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