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What is EU MDR 2017/745 Certification?

On April 5, 2017, the new EU MDR 2017/745 and EU IVDR 2017/746 have been passed in the European Parliament. EU MDR stands for European Union Medical Device Regulation and EU IVDR is the acronym of In Vitro Diagnostic Medical Devices Regulation. On May 5, 2017, Official Journal of the European Union has published the MDR and on May 25, 2017, it came into force. The transition period will come to an end and indeed this MDR becomes mandatory from May 25, 2020. The main purpose of this MDR is to ensure that the medical devices certified under EU MDR 2017/745 are safe and efficient to use in Europe. 

Why is EU MDR 2017/745 Certification Important?

EU MDR 2017/745 Certification is important because it aims at eliminating weaknesses prevailing in the earlier directives and tries to tighten the regulations to ensure better health and the safety of the Europeans using the proposed medical devices.  

How Can We Help?

EU MDR 2017/745 Certification is in place now and it comes into effect from mid of the year 2020. Though it seems like we have enough time, it is really not. It is high time to start working on the transitions from MDD to MDR. When compared to MDD, the MDR has more rigorous requirements and assessment procedures. So gap analysis needs time and all documents prepared for MDD earlier have to be reviewed and revised in order to meet regulations of EU MDR 2017/745 Certification. 

We are here to help you achieve the EU MDR 2017/745 Certification by doing a detailed gap analysis, thereby reviewing and revising the entire set of documents including the following:

  • Device classification based on risk-level

  • Technical file prepared for CE marking

  • Clinical Evaluation Report (CER)

  • Risk management file

  • Post-Market Surveillance 

  • Economic Operators Agreement

  • Product life cycle development plan 

So contact us right away and keep yourself ready and up-to-date for the transition from MDD to EU MDR 2017/745.