Work update: EU IVDR

2017/746 learnings
Presented by - Renuka Murmu
QA/RA Executive
 How to comply with the new In Vitro Diagnostic Regulation
 

(EU) 2017/746?

 Determine which risk category your device belongs to.

 Ensure your device conforms with the MDR and the standard specifications for these groups of
products.
 Pass a compliance assessment conducted by a notified body if required.
 Draw a declaration of conformity and affix a CE mark to the device.
 Provide the UDI database with a basic unique device identification (UDI) assigned to the device.
 If the manufacturer is outside the EU, submit essential information about the manufacturer, authorised
representative, and importer to the electronic system (Eudamed).
 Place your CE marked device on the market or put it into service anywhere in Europe.
 Meet the standards for post-market surveillance and vigilance, such as implementing field safety
remedial actions and reporting major events to the appropriate authority.
 Documents Checklist

 Risk Management Report (Annex I)

 Performance Evaluation along with Post-market performance surveillance and
vigilance(Article 52 and Annex XIII)
 Technical file (Annex II & III)
 Declaration of Conformity (Article 17)
 CE Mark the product (Article 18)
 UDI system (Article 24, 26, and 28)
 Product labelling (Annex I, section 20)
 Post-market surveillance system (Article 78)
Not just documents….

 record retention requirements for the technical file, Declaration of Conformity, and
certificates shall be increased from 5 years to 10 years
 document a procedure for communication with Competent Authorities, Notified Bodies,
Economic Operators, Customers, and/or other Stakeholders
 update procedures for reporting of serious incidents and field safety corrective actions in
the context of vigilance to require reporting within 15 calendar days
 revise the translation procedure to ensure translations of the instructions for use are
available in all required languages of the member states, and make sure these translations
are available on the company website
 create a procedure for utilization of the Eudamed database for registration, CE Marking
applications, UDI data entry, and vigilance reporting
Learning outcomes

 Basic UDI understanding, UDI-DI and generation of GTINs

 Technical Document preparation as per the new IVDR 2017/746

 Risk Management Report

 Performance Evaluation Plan
 Performance Evaluation Report
 Analytical Performance Report