Page 136 - Mart

S ğlık haber

Clinical benefi ts should always be superior to the risks of the What are your characteristics that distinguish you from compa-
device. This analysis should be carried out continuously in consi- nies that offer similar services?
deration of the clinical data about the device. All records regarding UDEM has a distinguished position from its competitors with
this assessment should be included in the PMS report (Class I) and its strategic investments for the future and its large number of its
the Periodic Safety Update Report - PSUR (for all other classes). highly trained staff and experts. UDEM Adriatic is the only noti-
PSUR should be updated at least every two years for Class II-a fi ed body established with 100% domestic capital, which has suc-
devices and at least every year for Class II-b and Class-III devi- cessfully completed the MDR audit and is waiting to be appoin-
ces. PSUR report of Class III devices will be reviewed by notifi ed ted in this regulation.
bodies and will be uploaded publicly to the EUDAMED system. In the framework of the European medical device harmoni-
In addition to Class III and Class IIb implants; annual sales zation legislations, how do you evaluate the current situation of
data of manufacturers will be publicly available in the EUDA- the fi rms in Turkey? What are your predictions about the future?
MED system. (Art. 86.1 c). As known, while being part of the European economic area,
EUDAMED (SRN, UDI and Data Entry) Turkey does not have a full membership in the European Union.
EUDAMED will be designed as a tool for the competent aut- Manufacturers in our country have the capacity to supply suitab-
horities and the European Commission to follow-up the entire le and quality products to the market within the framework of
medical device industry. Manufacturers, Authorized Representa- the European Union harmonization laws. Our Ministry of Health
tives and Importers will be listed as registered in EUDAMED. It works very intensely to harmonize the legislation. Our manufac-
is mandatory for the demonstration of the suitability of the devi- turers established with domestic and national capital, will achie-
ce’s distribution chain. Certain parts of EUDAMED will be acces- ve signifi cant success in the new legislative harmonization phase.
sible to the public. All economic operators must use SRN (Single With the new MDR, it is important for our manufacturers to
Registration Number) to login to EUDAMED. A company with make the necessary planning especially for clinical studies. The
multiple functions must have more than one SRN number. (For suitability and quality of the devices must be proven by systema-
instance, for a company that is an authorized representative and tic clinical studies.
importer: two separate SRNs are required). The competent aut- What is your vision as UDEM?
hority will verify the company information before the SRN num-
ber is issued. EUDAMED registration will not be created without ‘‘UDEM WILL CONTINUE TO OFFER SERVICE
the SRN number. AS THE LEADING COMPANY’’
SRN should also be included in the conformity assessment UDEM will continue to offer service as the leading company
certifi cates. Unique Device Identifi cation (UDI) will be activated in terms of evaluating the compliance of medical devices with the
for each device. With UDI, the full ensuring of device traceabi- legislation. UDEM’s most important vision is to become the wor-
lity is aimed. Periodic Security Update report (PSUR) and Sum- ld’s largest organization in this fi eld together with UDEM Adria-
mary Security and Clinical Performance Report (SSCP) for class tic, which will start offering service in the new MDR fi eld soon.
III devices will be uploaded to EUDAMED. The information on The new MDR contains detailed and stringent requirements
EUDAMED will be checked and verifi ed every year, and the old for all parties, but it will also ensure appropriate and quality pro-
data will remain available in EUDAMED and will not be deleted. ducts fi nd the value they deserve in the market.

134 / Mart 2020