In May 2017, Regulation (EU) 2017/745 of the

European Parliament and of the Council of 5 April 2017 on medical devices ("EU Regulation") entered into force, stipulating

a transition period for medical device manufacturers to comply with the EU

Regulation by May 2020.

In May 2017, Regulation (EU) 2017/745 of the European

Parliament and of the Council of 5 April 2017 on medical devices ("EU Regulation") entered into force, stipulating

a transition period for medical device manufacturers to comply with the EU

Regulation by May 2020.[1] As

the title of the EU Regulation suggests,[2] it

lays down enhanced rules on medical devices, manufacturers, distributors,

importers, and notified bodies. For any medical device to be put into and sold

on the market, full compliance with the EU Regulation is required. The EU

Regulation introduces and addresses several new principles and renders

procedures pertaining to medical devices more transparent, trackable and

predictable. These changes aim to ensure a high level of safety and protection for

patient health and for the users within this industry, also taking into

consideration the technological evolution and developments in this field.

In Turkey, the Medical Device Regulation, which is

based on the Council Directives 90/385/EEC and 93/42/EEC and which entered into

force on June 7, 2011, is currently still in force and effect. Recently, a draft

Medical Device Regulation ("Draft

Regulation") has been prepared and announced by the Turkish Ministry of

Health, with the intention and purpose of harmonizing and aligning the Turkish regulatory

framework for medical devices with the new EU regulations.[3]

The Draft Regulation contains requirements that are in

parallel (indeed, almost identical) to those put forth by the EU Regulation, while

also addressing a few local issues and principles that are specific to Turkey. A

translated version of the EU Regulation was first published on the official

website of the Turkish Medicines and Medical Devices Agency ("Agency"), the authorized body for the

enforcement of the Draft Regulation, and was opened to public comment in order to

receive and gather opinions from interested parties. Subsequently, the Draft

Regulation was published on the Agency's official website, requiring interested

parties to convey their ideas, suggestions and comments to the Agency by November

16, 2018.

In this regard, it is safe to say that the Draft

Regulation contains very similar regulations-even direct translations-to those set

out in the EU Regulation. Accordingly, certain significant changes that have

been introduced through the Draft Regulation are summarized below:

-

Addressing

a critical issue, the Draft Regulation clearly prohibits labels, usage

instructions and advertisements relating to a device's intended purpose, safety

and performance from including misleading texts, names, trademarks, pictures,

and figurative or other signs by (i) ascribing functions and properties to the

device that the device does not possess, (ii) creating a false impression

regarding any functions or properties related to treatment or diagnosis that the

device does not have, (iii) failing to inform the user or patient of a potential

risk associated with the use of the device in line with its intended purpose,

and (iv) suggesting areas of use for the device other than those specified to

form part of the intended purpose for which a conformity assessment has been carried

out.

-

Another

significant change introduced by the Draft Regulation pertains to the

obligations of manufacturers, importers and distributors, as the current Medical

Device Regulation (which is still in effect) contains several provisions with

respect to manufacturers' obligations under a number of articles, but little to

no regulation with respect to those of importers and distributors. In this

regard, the obligations of manufacturers, importers and distributors are increased

and become more detailed through the Draft Regulation. In this context, manufacturers

are required to prepare and to regularly update the EU declaration of

conformity. They are also required to fulfill their obligations with respect to

(i) establishing a risk-management system, (ii) conducting a clinical

evaluation for tracking their devices that have been put into market, (iii) preparing

and updating the technical documentation of their devices, and (iv) establishing

a quality-management system. Manufacturers must retain and have available at

least one person within their organization who will be responsible for

regulatory compliance, and who must possess specific qualifications. In the

event that the manufacturer of a device does not reside in Turkey or in an EU

Member State, the device may only be put into market by the authorized

representative of the manufacturer. Increased and enhanced responsibilities have

also been placed upon the importers and distributors of medical devices.

-

The

Draft Regulation also comprises several changes in relation to the medical devices.

While the product classifications remain the same, certain new procedures have

been introduced with respect to the registration of the devices. The current Medical

Device Regulation simply requires the Ministry of Health to ensure the local registration

and evaluation of certain information pertaining to devices, whereas the Draft

Regulation, parallel to the EU Regulation, introduces international registry

systems, such as the Unique Device Identification (UDI) and EUDAMED schemes, on

top of the local registration requirement.

-

The

Draft Regulation also addresses issues relating to confidentiality and data

protection, and requires the protection of personal data, commercially

confidential and sensitive information, and information obtained during

inspections, investigations, or audits.

As the notified bodies (which are currently authorized

to grant the conformity certificate for medical devices to manufacturers) will also

be required to meet and fulfill additional specifications in order to obtain their

licenses and to continue operating, the Draft Communiqué on Notified Bodies

Operating in the Medical Device Sector ("Draft

Communiqué") has been prepared and published on the Agency's official

website as well.[4]

The announcement of the Draft Communiqué also includes a comparison chart with the

relevant articles of the EU Regulation, indicating that the Draft Communiqué

has been prepared based on the EU Regulation.

The publication and enforcement dates of the Draft

Regulation and the Draft Communiqué have yet to be announced. However, in light

of the extensive similarity between the Draft Regulation and the EU Regulation,

and considering that the EU Regulation provides a transition period of three

years, we might reasonably anticipate that the Draft Regulation will stipulate a

similar transition period for compliance after entering into legal force.

Authors:

Gönenç Gürkaynak, Esq., Ceren Yıldız and Nazlı Gürün, ELIG Gürkaynak

Attorneys-at-Law

(First published by Mondaq on January 8,  2019)

[1] Please see http://data.europa.eu/eli/reg/2017/745/oj for the EU Regulation.

[2] The full title of the EU Regulation is "Regulation

(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on

medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and

Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and

93/42/EEC."

[3]

Please see http://titck.gov.tr/duyuru/3390 for the

announcement and the draft regulation.

[4]

Please see http://titck.gov.tr/duyuru/3295 for the

announcement and the draft.