Medical Device Directive (EU) 2017/745

In order to protect patient and user health, the European Union (EU) has made a major change in medical device legislation 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 within the Scope of 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);
• Enhanced 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 multicentre 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 guides 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 guides 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 guides on the TITCK web page 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 approved organizations through the NANDO Information System to receive conformity assessment service. 

You can access the UDEM (2292) MDR assignment scope from the link below:

https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7

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

MDR Standard Fee List

APPLY

To receive MDR conformity assessment service from UDEM A.Ş.; By filling out the application form you will download,mdr@udem.com.trYou can send it to your e-mail address.

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

Technical Documentation Content Guide

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3. ERA Management Testing and Certification Service. Inc.

4. Guinea Pig Experimental Animals Laboratory Industry and Trade Inc.

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