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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.