UDEM IT Department

UDEM IT Department

In today’s digital world, security threats are rapidly increasing.

MORE
Our Notified Body Opinion Service, Which We Offer Within The Scope Of Article 117 Of (EU) 2017/745 Medical Device Regulation, For Manufacturers To Market Their Drug-Device Combination Products As An Integrated Device

Our Notified Body Opinion Service, Which We Offer Within The Scope Of Article 117 Of (EU) 2017/745 Medical Device Regulation, For Manufacturers To Market Their Drug-Device Combination Products As An Integrated Device

Article 117 of (EU) 2017/745 Medical Device Regulation (MDR) requires manufacturers who market drug-device combination products as an integrated device...

MORE
MDR Transition Process FAQs

MDR Transition Process FAQs

The Turkish Medicines and Medical Devices Agency has published answers to frequently asked questions regarding the extension process under Regulation (EU) 2023/607.

MORE
MDR Transition Process

MDR Transition Process

With the Regulation (EU)2023/607, the validity periods of MDD certificates have been extended, provided that certain conditions are met. ​

MORE
MDR Technical Documentation Content Guide

MDR Technical Documentation Content Guide

You can access the Technical Documentation Content Guide, which we have prepared for the purpose of informing manufacturers, taking into account the MDCG 2022-14 guide and referencing the Team-NB Position Paper...

MORE
Legal Notification for the MDR Process

Legal Notification for the MDR Process

You can have a look at the details of our new to see the Announcement Notification for the Medical Device Arrangement Process.

MORE
Announcement on the Significant Changes in the MDR Process

Announcement on the Significant Changes in the MDR Process

As of May 26, 2021, Approved Institutions appointed under 93/42/EEC Directive will not be able to have another first certification but it has been announced...

MORE

UDEM Certificate

We crown our achievements with originality with our sector experience and expert personnel, we continue to be the choice of professionals.

Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Turkey, but also in the global market, we are expanding our international network every day.

Continue on udem.com.tr

Select the website you want to go to.

Any addresses, social media platforms, or online sources other than the specified websites do not belong to UDEM A.Ş. and do not reflect our organization's information. To avoid encountering false or misleading information, we recommend obtaining information only through these official websites.

We use cookies on this website to improve your user experiene. You will have accepted our use of cookies if you continue.Cookie Policy OK