La nouvelle régulation Européenne des dispositifs médicaux

The new Medical Devices Regulation (MDR) has been in force since May 2017 and after a transitional period of three years, the full application of the new rules takes effect in 2020.

A. Explanations and useful links

      • For the MDR major changes from MDD: https://www.tuv-sud.com/uploads/images/1502851312062322670786/tuv-sud-mdr-factsheet.pdf
      • Use the links from competitors (but of course without sending to their own page):
        • Europe Medical Device Regulation (MDR) - PDF
        • MDCG guidance : http://ec.europa.eu/growth/sectors/medical-devices/guidance_en  
        • EU commission on the regulatory framework for Medical devices : https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

New codes for NBs under the EU regulation : https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R2185

B. Where are we in our designation process. 

We need to confirm if we want to communicate on this matter because we were quite late in applying. The 1st NB applied on Nov 27, 2017. We were probably the 34th among 40 to 50…

      1. Kiwa Cermet applied to the Italian Ministry of Health in October 2018
      2. Our application has been forwarded to the European Commission and we are currently waiting for the date of our joint assessment
      3. We aim for a joint assessment during spring 2019 and a designation by the end of 2019

C. Our process to obtain it (only after we will be designated, probably end of 2019)

      • Documents from the EU commission :
  • Information for manufacturers
        • Factsheet for manufacturers of medical devices
          Implementation model: medical devices
          Exhaustive list: requirements for medical devices manufacturers
      • More available after our designation????
    • Regulatory news as the new regulation require many new texts and commissions to be created[GL1] 
      • A list of documents could be made here
    • Our training sessions on this topic (To be developed …)