In order to protect patient and user health, the European Union (EU) has made a major change in medical device directive with stricter requirements in order to improve quality, safety and performance data in medical devices and to harmonize all sector stakeholders, whether manufacturers, notified bodies or competent authorities. The New Medical Device Regulation came into force on May 25, 2017 and started to be implemented as of May 26, 2021 (DoA - Date of Application) with the completion of the four-year transition period. The implementation of the 93/42/EEC Medical Device Directive (MDD) has also ended as of this date.

Improvements under MDR

• Stricter preliminary control for high-risk devices through a new pre-market review mechanism with a pool of experts at EU level;
• Strengthening criteria for appointment and oversight of Notified Bodies
• Including some aesthetic devices that have the same features and risk profile as similar medical devices within the scope of the regulation (Annex XVI);
• Improved transparency through a comprehensive EU database on medical devices (EUDAMED)
• A traceability system based on the UDI system;
• Requirement for an “implant card” containing information for patients with implantable medical devices;
• Strengthening the rules on clinical evidence, including an EU-wide coordinated procedure for authorizing multicenter clinical trials;
• Strengthening post-market surveillance requirements for manufacturers;
• Improved coordination mechanisms on vigilance and market surveillance among EU countries;
• A robust financial compensation mechanism that allows patients to compensate for harm caused by defective devices.

It is important that the guidelines prepared by MDCG (Medical Device Coordination Group) regarding applications within the scope of MDR are followed and implemented by manufacturers and notified bodies. You can access the relevant guidelines via the link below.
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

You can also access the Turkish translations of the relevant guidelines on the TITCK website below.
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihaz-mevzuati

Application Process

Before starting the medical device conformity assessment process, you must verify whether your product is a medical device according to the MDR medical device definition. If your product meets the definition of a medical device, you can check the conformity of the scope of notified bodies through the NANDO Information System to receive conformity assessment service.

You can access the UDEM (2292) MDR designation scope from the link below:
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7

You can access the pricing details regarding medical device conformity assessment activities carried out by UDEM A.?. through the MDR Standard Fee List document.

MDR Standard Fee List

APPLY NOW

To receive MDR conformity assessment service from UDEM A.?.; You can download and fill out the application form and send it to your e-mail address mdr@udem.com.tr.

You can access the Technical Documentation Content Guide document, which has been prepared for informational purposes for manufacturers, via the link below.

Technical Documentation Content Guide

Our Subcontractor Laboratories

1. AYA Validasyon Ambalaj Sterilizasyon A.?.

2. LVT Test Laboratuvarlar? Ltd. ?ti.

3. ERA Yönetim Test ve Belgelendirme Hiz. A.?.

4. Kobay Deney Hayvanlar? Laboratuvar? Sanayi ve Ticaret A.?.

5. Udem Uluslararas? Belgelendirme Denetim E?itim Merkezi San. ve Tic. A.?. - Test Laboratory