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Medical Gadget Regulation (“Regulation”) has been
revealed within the Official Gazette numbered 31499 on 2 June
With the Regulation ready in accordance with the EU Medical
Gadget Regulation numbered 2017/745 (“MDR”), it’s aimed
to supply a safer use for producers and medical system customers
with a clear and sustainable system.
On this context; new noteworthy provisions are the definition of
a medical system, classification of merchandise, distance gross sales,
producer, importer and distributor liabilities in putting
merchandise available on the market, the EUDAMED system, medical analysis in
medical units, notified our bodies.
With a view to present a transition interval for the brand new rules
launched by the Regulation, numerous efficient dates have been
foreseen for a number of articles in accordance with the EU transition
i. Medical Gadget Definition, Classification of Merchandise and
The definition of “medical system” now contains
- Gadgets having goal of offering data by way of in
vitro examination of specimens derived from the human physique,
together with organ, blood and tissue donations and
- Merchandise particularly supposed for the cleansing, disinfection
or sterilization of units as referred to within the definition.
have additionally been outlined as medical units.
The Regulation as soon as once more qualifies medical units in 4
completely different danger courses (class I, IIa, IIb and III). Nevertheless,
classification amendments are stipulated for sure units with
new rules made within the classification guidelines. Specifically,
the variation of the danger class of some Class I medical units
would require notified physique inspection and EC certificates within the new
The appliance process to the European Union Fee has
been organized by the Turkish Medicines and Medical Gadgets Company
(“the Company”) with a view to make clear the regulatory standing
of the merchandise on the borderline, within the analysis to be made as
as to whether the merchandise fall inside the scope of the definition of
ii. Distant and Distance Gross sales
Underneath Article 6 of the Regulation, it has been regulated that
medical system shall be supplied by way of “data
society companies”. Nevertheless, no definition is offered for
data society companies within the Regulation. Within the related
Article of the MDR, a reference is made to a different EU laws
(EU Directive 2015/1535) relating to the definition of
“data society companies”; nevertheless, there is no such thing as a
parallel regulation in Turkish legislation.
Due to this fact, one can say that there’s a gray space within the
laws relating to the channels by way of which distant and
distance gross sales might be carried out. Nevertheless, the EU laws, to
which the regulation in Turkey was ready in parallel, defines
the knowledge society service as “despatched initially and
obtained at its vacation spot by way of digital gear for
the processing (together with digital compression) and storage of information,
and completely transmitted, conveyed and obtained by wire, by radio,
by optical means or by different electromagnetic means”.
The Company has not revealed any announcement but, on how this
article shall be interpreted along with the rules
relating to the gross sales on the web regulated by the Regulation on
Medical Gadget Gross sales, Promotion and Promoting.
iii. Liabilities of Exporter-Importer-Distributor, Particular person
Accountable for Regulatory Compliance and Approved
The liabilities of exporter, importer and distributor of medical
units have been individually regulated intimately within the Regulation.
Nevertheless, there is no such thing as a regulation whether or not the gross sales centres outlined
because the place the place the units are bought within the Regulation on
Medical Gadget Gross sales, Promotion and Promoting, fall within the group
of producers, importers and/or distributors.
As well as, if the producer of the medical system shouldn’t be
situated in Turkey or EU member international locations, the system can solely be
positioned available on the market offered that a licensed consultant is
appointed in Turkey.
Producers are required to have not less than one particular person in cost
of regulatory compliance, who known as “particular person accountable
for regulatory compliance”, with the mandatory experience in
the sphere of medical units, inside their group. There may be
no regulation as as to whether the particular person answerable for regulatory
compliance might be the identical particular person because the “accountable
particular person” regulated within the Regulation on Medical Gadget Gross sales,
Promotion and Promoting.
iv. European Union Database on Medical Gadgets (EUDAMED)
With a view to enhance transparency and improve traceability in
the medical system business, the EUDAMED system of the European
Union Fee has been included within the Regulation in accordance
with the MDR. On this context, the needs of registration and the
data to be registered are regulated. As well as, it has
been regulated that the obligations on the Product Monitoring System
(“ÜTS”) will proceed. The EUDAMED system, which
can be open to the general public, can be prepared to be used in six months
after its publication within the Official Journal of the European Union
and a discover that its useful specs are met.
After we take a look at the information which might be required to be registered in
EUDAMED, notifications containing affected person information akin to single
system monitoring and opposed occasion report can be made by way of
publicly obtainable EUDAMED, and due to this fact private information can be
processed and recorded by way of EUDAMED. This information can be processed
by Turkey and EU member states, notified our bodies, financial operators
As well as, by inclusion of a particular disposition relating to the
safety of non-public information, additionally it is regulated that the Legislation on
the Safety of Private Knowledge and different laws on the
safety of non-public information may even be utilized.
When thought-about inside the scope of the Legislation on the Safety of
Private Knowledge, since with the EUDAMED notifications, it’s required
to each gather and course of well being information and switch these information
overseas, express consent of the sufferers can be required. The
problem of acquiring express consent and informing the related
individuals beforehand could create difficulties in observe. From the
perspective of the EU, the information within the EUDAMED may even be
transferred to Turkey.
v. Scientific Analysis
Detailed regulation on medical trials of medical units is
included within the Regulation. Nevertheless, because the Regulation on
Scientific Trials of Medical Gadget is presently in power and has not
been abolished by the Regulation, a disposition is required
relating to which of those two competing rules can be taken
vi. Notified Our bodies
The Regulation introduces extra management and monitoring by the
Company and the EU Fee, the EU government physique, and stricter
circumstances for the appointment of Notified Our bodies. Notified Our bodies
are organizations assigned to evaluate the conformity of medical
units with the relevant elementary technical necessities
earlier than putting available on the market.
The analysis of conformity evaluation our bodies that apply
appointment as a notified physique can be carried out by the
“joint evaluation workforce” consisting of the Company, the EU
Fee representatives, and the representatives of the
project authorities of two completely different EU member states. The
Company has already began to just accept the Notified Physique
The conformity evaluation our bodies appointed by the Company are
notified to the EU Fee band EU member states by the Ministry
of Commerce by way of NANDO, the EU Notified Our bodies Info
System and until an objection is raised, the notification is
revealed on NANDO inside 42 days as of the notification.
An announcement has been revealed by The Company on 26 Could 2021
relating to how lengthy the present EC certificates can be legitimate.
Throughout this transition interval, producers ought to begin
cooperating with Notified Our bodies to plan the brand new certification
schedule for his or her medical units and the provision of the
Notified Physique, the extra information want on units and the
transitional provisions within the Regulation must be taken into
The Regulation entered into power on the identical date because the MDR,
to which it’s suitable to; and business stakeholders are guided
by bulletins of the Company to make sure compatibility with all EU
Whereas it was essential to plan the compatibility with the MDR in
the preparation of the Regulation, it’s noticed that not all of
the opposite rules in power in Turkey are taken into consideration.
Though the implementation of the Regulation will change into clear
with the bulletins revealed by TITCK, it’s anticipated that
different Turkish rules of TITCK may even be up to date in line
with EU laws.
The content material of this text is meant to supply a normal
information to the subject material. Specialist recommendation must be sought
about your particular circumstances.