On May 26, 2021, the MDR (Medical Device Regulation) will finally come into force
PMS, PMCF, PSUR, CEP, SS&CP, AIMDD, CER, CAPA, EUDAMED... anyone who now feels reminded of the song by a well-known German band is not entirely wrong. Together with the MDR, a plethora of new abbreviations of sometimes somewhat unwieldy English terms has also entered the European Union: Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF) or Periodic Safety Update Report (PSUR), for example, are additional reports and documented plans to be prepared and reviewed. A CAPA is a "Corrective and Preventive Action" - a corrective and preventive action that refers to improvements in processes to eliminate nonconformances or other adverse events. (1)
In the medical device industry, these terms are almost old hat by now, as we have known that the MDR will come into effect not just since the 3-year transition period started in 2017. And if you're rubbing your eyes in surprise now: that's right, 2017 + 3 actually means 2020. In light of the Covid 19 pandemic, the EU agreed to an MDR moratorium at the beginning of 2020, and extended the transition period by 1 year.
The EU's new Medical Device Regulation (MDR) regulates the placing on the market, making available on the market and putting into service of medical devices and accessories intended for human use. The MDR introduces a completely revised regulatory system that will replace the current Medical Device Directive (MDD) approval system for medical devices ranging from implants to reusable surgical instruments or software.
But back to the abbreviations: of course, they don't just provide material for a detailed MDR bingo. Rather, they conceal activities, measures, regulations or groups of persons, some of which are extremely extensive. The entire medical technology industry has therefore been preparing for the time after May 26, 2021, with a high level of financial and personnel commitment for several years.
However, the fact that the framework conditions are not yet sufficiently in place presents manufacturers with additional major challenges. "At this point in time, (...) only 5 of 50 possible legal acts have been issued by the EU Commission. At the start of validity, no harmonized standards will exist either. The expert committees are not yet ready for work. In addition, there are delays with EUDAMED, the digital backbone of the MDR," says Dr. Christina Ziegenberg, deputy managing director and head of the Regulatory Affairs department at BVMed in a BVMed press release dated March 12, 2021. (2)
But even if the framework conditions have not yet been met, we manufacturers are of course doing our homework and giving substance to the abbreviations in our own company. You can read about how far TRACOE medical has come in the meantime in our next blog post.
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