• Result of manufacturing drawings
  • Result of testings (e. g. material testings, pharmacological-toxicological examinations, data of biocompatibility, examinations of stability, cleanroom surveillance)
  • Results of technical testings (e. g. EMC, electrical safety) and certficates if applicable
  • Compatibility studies (connection to other medical devices)
  • Risk management documentation (EN ISO 14971)
  • Clinical data (especially for products of class IIb and III as well as (e. g. Article 15/Annex 10, MEDDEV 2.7.1, EN 14155-1/-2)

 

  1. Validation of the packaging/ageing studies (usability duration)
  2. Process validation (e.g. sterilization, manufacturing, production)
  3. Software validation

Medical devices play an important role in both the diagnostic and therapeutic care of patients.

The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers.

#D microscope

A new microscope technology allows us to see cells and tissues like we've never seen before.

Find out more at https://hms.harvard.edu/news/boldly-go

Like Harvard Medical School on Facebook: https://goo.gl/4dwXyZ

Triple Rainbow

Is it a single rainbow? A double rainbow? Dare we say it - a TRIPLE rainbow??

  • Result of manufacturing drawings
  • Result of testings (e. g. material testings, pharmacological-toxicological examinations, data of biocompatibility, examinations of stability, cleanroom surveillance)
  • Results of technical testings (e. g. EMC, electrical safety) and certficates if applicable
  • Compatibility studies (connection to other medical devices)
  • Risk management documentation (EN ISO 14971)
  • Clinical data (especially for products of class IIb and III as well as (e. g. Article 15/Annex 10, MEDDEV 2.7.1, EN 14155-1/-2)

 

  1. Validation of the packaging/ageing studies (usability duration)
  2. Process validation (e.g. sterilization, manufacturing, production)
  3. Software validation

Medical devices play an important role in both the diagnostic and therapeutic care of patients.

The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers.

#D microscope

A new microscope technology allows us to see cells and tissues like we've never seen before.

Find out more at https://hms.harvard.edu/news/boldly-go

Like Harvard Medical School on Facebook: https://goo.gl/4dwXyZ

Triple Rainbow

Is it a single rainbow? A double rainbow? Dare we say it - a TRIPLE rainbow??

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