MDR/IVDR European database on medical devices (EUDAMED)

•  IT system developed by European commission
• Developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
• Improve the transparency
• Coordination of information regarding medical devices available on the EU market

Article 33 EUDAMED contains following 6 modules,

Electronic system	MDR Article	IVDR Article
Electronic system for registration of devices	Article 29(4)	Article 26
UDI-database	Article 28	Article 25
Electronic system on registration of economic operators	Article 30	Article 27
Electronic system on notified bodies and on certificates	Article 57	Article 52
Electronic system on clinical investigations	Article 73	MDR ONLY
Electronic system on performance studies	IVDR ONLY	Article 69
Electronic system on vigilance and post-market surveillance	Article 92	Article 87
Electronic system on market surveillance	Article 100	Article 95

Medical devices nomenclature

•        Article 26 of Regulation 745/2017 and Article 23 of Regulation 746/2017

•        Free of charge

•        internationally recognized

•        Future nomenclature should facilitate the establishment of links with the codes defining Notified Bodies competence (designation scope) , the scope of medical devices QMS (Quality Management System)/QA (Quality Assurance) certificates, and product portfolios in the mandate of Authorised Representatives.

•        Hierarchies by which terms and codes could be meaningfully grouped into categories and subcategories

•        Periodic review of nomenclature terms and descriptions, this shall be taken into account.

•        Classificazione Nazionale Dispositivi medici (CND)’ as the basis for the EMDN . CND is currently used in Italy, Portugal and Greece.

•         Revision of the CND is ongoing so that to release the first version of the EMDN

•         Commission will map the EMDN to the Global Medical Device Nomenclature (GMDN)

Guidance documents:

European Medical Device Nomenclature (EMDN)

Title	Publication
The EMDN – The nomenclature of use in EUDAMED	January 2020
The CND nomenclature – Background and general principles	January 2020
Future EU medical device nomenclature Description of requirements	MDCG 2018-2

 

EUDAMED

Title	Publication
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States	August 2020
Registration of legacy devices in EUDAMED	April 2019
Timelines for registration of device data elements in EUDAMED	April 2019

 Web Links :

https://ec.europa.eu/health/md_eudamed/overview_en

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

Source :

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU