medical devices regulation

[Blog] MDR – is still a hot and challenging topic for Medical Devices Industry

More than a year after MDR went live, supply chain participants already discovered the benefits together with the challenges








Medical Devices Regulation (MDR) was one of the key moments in 2021 to establish traceability enhancement from Manufacturers to Patients. And one year later, the interest remains that way. Moreover, MedTech Industry marks dynamic progress this year. Some of the vital success insights are:


benefit The value of the Medical Devices Market on the global level reached USD 495.46 billion. The projection is to reach USD 781.92 in 2029

benefit Post-COVID-19 effect – after the cancellation of the restrictions regarding medical procedures and surgeries, it is noted a sudden rise in the demands for medical devices due to loads of interventions

benefit The rising prevalence of chronic disorders, diabetes, and cancer increased the need for diagnostic procedures and tests, which boosted the demand for medical devices

benefit The pandemic imposed the trend of “Homecare”, and its post-effect could be reported now as the need for portable devices for in-home treatment is significantly higher




The fields of medical and in-vitro device manufacturing are in front of the development era. However, from our extensive experience, we know that combining significant demands and brand-new regulatory requirements could create a futuristic picture. Based on unofficial research, we could show you that even after one year (MDR went live a year ago), the UDI turned out to be still a “delicate topic” for MedTech supply chain participants. The respondents indicated that the primary challenges with the UDI Data are as follows: (1) data quality, (2) data management and control, (3) new DI/ GTIN triggers and (4) data exchange.


professional opportunity Watch the webcast “Meeting the UDI requirements for Medical Devices and In-vitro Devices by GS1 and SoftGroup”


professional opportunity Read the blog “What does Master UDI-DI stand for?”




Furthermore, it turned out that the supply chain participants found the implementation process challenging, because of the presence of the following:


  • Lack of funding for necessary IT improvements
  • Lack of clarity about the requirements
  • Lack of resources and expertise
  • Lack of regulatory or commercial imperatives


professional opportunity More about UDI & Implementation


professional opportunity More about UDI Requirements Worldwide




Nevertheless, the Medical Devices Industry acknowledges the contribution of MDR to establishing an efficient mechanism against medical device counterfeiting. The key benefits that the supply chain participants pointed out are:


  • Identification of devices in adverse events, recalls
  • Better supply chain visibility
  • Reduction of medical errors
  • Documentation of devices in/during clinical use



After all, the main purpose behind all these new requirements and systems is to create a better future. The MedTech industry is following the steps of Pharma, imposing traceability as a key factor for the future-ready patient-oriented healthcare system.