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laboratory also started to offer electrical test services on medi- offers system certifi cation (ISO 9001 and ISO 13485) servi-
cal devices in 2016. In 2017, in asmuch as to provide service ces. Also, it is authorized by the European Commission with
to the geographically distanced areas on a local scale, UDEM number 2696.
China and UDEM South Korea offi ces have begun to take acti- UDEM Adriatic will be offering services as a notifi ed body
on. Both as an accredited organization and as the pioneer of within the scopes of;
the certifi cation sector, UDEM provides verifi cation services Machinery Safety Regulation
for greenhouse gases within the scope of the regulation con- Medical Device Regulation (MDR) (Expected to be obta-
cerning greenhouse gases published in our country. ined in the beggining of 2020)
With our 12 years of experience, in 2015, UDEM Adri- There are important developments regarding medical device
atic was established in Croatia, which is the full member of legislations in Europe. In this sense, can you give information
the European Union and will be the President Country of the about MDR, which will be actualized in 2020? What is MDR
EU Council in 2020. UDEM Adriatic offers system certifi - and why is it important for our fi rms? What awaits our fi rms?
cation (ISO 9001 and ISO 13485) service as a notifi ed body
with number 2696 obtained from the local accreditation orga- “ALL CLINICAL RESEARCHES CAN BE DONE
nization in Croatia. UDEM Adriatic has successfully comp- BASED ON THE DETAILED REQUIREMENTS
leted audits in the fi eld of new medical device regulation and IN MDR’’
is expected to obtain authorization by the European Commis-
sion in the near future. The basic changes regarding MDR, which will be imple-
UDEM is an organization that has superiority relying both mented in 2020, can be summarized in the following sub-tit-
on its global reach extending from the Pacifi c Ocean to the les. MDR is a regulation describing numerous details and deta-
Adriatic Sea and its highly trained staff and experts. iled obligations for all economic operators. Whereas there are
23 articles and 14 defi nitions in 12 appendices in the current
The number of accredited certifi cation companies is not very effected medical device regulation, the new MDR includes
high, but I think the demand is too high. What certifi cation 123 articles, 17 appendices and 71 defi nitions.
services do you offer within this context? Economical Operators
Accredited by TURKAK, offers system certifi cation (ISO Importers and distributors are defi ned in MDR. Manufa-
9001 and ISO 13485), electrical testing and verifi cation ser- cturers must control the supply and distribution chain within
vices for medical devices and greenhouse gases. Besides, it is the medical device lifecycle. Spot checkings will be carried
authorized by the European Commission with number 2292. out by notifi ed bodies to companies in the supply chain. The
UDEM offers service as a notifi ed body within the scopes of; control of the distribution chain should be part of the QMS.
Medical Device Regulation The characteristics of the distribution chain should create an
Elevator Regulation input for the design of the devices. Importers and distributors
Construction Products Regulation in the distribution chain take part actively in vigilance and
Machinery Safety Regulation PMS situations. In other words, compliance with the produ-
UDEM Adriatic, established again by the same team and ct-related regulation should also be done by importers and dist-
accredited by the local accreditation organization in Croatia, ributors, and inappropriate situations should be reported to the

132 / Mart 2020