{"id":16772,"date":"2020-12-02T11:55:28","date_gmt":"2020-12-02T10:55:28","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16772"},"modified":"2020-12-02T11:55:28","modified_gmt":"2020-12-02T10:55:28","slug":"may-26-2021-mdr-eu","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/12\/02\/may-26-2021-mdr-eu\/","title":{"rendered":"May 26, 2021 MDR: time to act now!"},"content":{"rendered":"\n

Short time to May 26, 2021<\/strong> which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017\/745<\/strong>. <\/p>\n\n\n\n

If you are a Manufacturer, an Economic Operator or another interested party, you must take action as soon as possible to apply the requirements and be ready for the deadline. <\/p>\n\n\n\n

To help you,\nhere is a summary of the main changes.<\/p>\n\n\n\n

\"may
MDR (EU) 2017\/745: time to act now!<\/figcaption><\/figure>\n\n\n\n

What does the MDR (EU) 2017\/745 entail?<\/strong><\/h2>\n\n\n\n

In general,\nthe Medical Devices Regulation maintains all the requirements of the previous\nDirectives (AIMDD e MDD) adding new and stricter ones in line with the\ndevelopment of the global medical device market. It is however a real new Certification<\/strong>, seamlessly with the\nprevious regulation.<\/p>\n\n\n\n

Below the 9 <\/strong>most innovative topics <\/strong>of the MDR (EU) 2017\/745.<\/p>\n\n\n\n

  1. More details on the Clinical Evaluation process<\/strong>, with the Post-market Clinical Follow-up applied throughout the life cycle of the device. <\/li>
  2. Need to perform a timely reclassification of devices<\/strong>.<\/li>
  3. New obligations and responsibilities for Economic Operators<\/strong>. <\/li>
  4. Stricter requirements<\/strong> for the designation of Notified Bodies <\/strong>and greater control and monitoring by the Competent Authorities and the European Commission.<\/li>
  5. Obligation to identify and empower the Person Responsible <\/strong>for compliance with the MDR (EU) 2017\/745 Regulation.<\/li>
  6. Stricter Vigilance and Post-Market Surveillance (PMS<\/strong>). <\/li>
  7. Further definition of the Technical Documentation<\/strong> to be drawn up.<\/li>
  8. UDI system <\/strong>(unique device identification) to improve the traceability of medical devices.<\/li>
  9. EUDAMED<\/strong>: European database that collects in a single database the data of all Medical Devices and in Vitro Diagnostic Medical Devices.<\/li><\/ol>\n\n\n\n

    MDR May 26, 2021: what challenges for Economic Operators?<\/strong><\/h2>\n\n\n\n

    We have seen that the MDR contains many novelties <\/strong>and that each Economic Operator must comply with it by May 26, 2021.<\/p>\n\n\n\n

    It should be known that not everything provided for in the MDR, for example the database EUDAMED, may be fully operational before the date of application.
    Despite this, however, it is necessary to apply as much as possible and to foresee what is not yet present: it is good therefore to act now to be ready in time<\/strong>.<\/p>\n\n\n\n

    If you are a Manufacturer<\/strong> we suggest that\nyou now prepare a MDR action plan to make sure that:<\/p>\n\n\n\n