Use-Lab Approval process

Approval process

In Germany, the Medical Devices Act requires a CE label for medical devices and in vitro diagnostics intended for performance evaluation purposes. Similar regulations also apply to other European countries.

Use-Lab supports its clients during the approval process with the creation of files, legal issues, market entry and implementation by providing the following services:

  • Preparation of usability engineering files in accordance with IEC 62366-1:2015, IEC 62366:2007 and IEC 60601-1-6
  • Consultancy on the Medical Devices Act (medical device classes, country-specific law)
  • Consultancy on approval in different markets (CE, FDA, PAL, CCC, etc.)
  • Consultancy on integrating risk management and the usability engineering process into in-house development processes

Assistance with approvals

To obtain the CE label, legistlation stipulates that medical devices must be designed safely with regard to their technological and ergonomic features.

Due to amending directive 2007/47/EC to the Medical Device Directive 93/42/EEC, relevant standards on usability and risk analysis which, until then, served only as orientation, became binding. Here, the following standards are of particular interest:

  • Standards on the usability of medical devices (IEC 62366-1:2015, IEC 62366-2007 and IEC60601-1-6 )
  • Standards on the application of risk management in the development of medical devices (ISO 14971)
  • Standards on quality management of the development process (ISO 13485)

Use-Lab provides advice and support in the documentation of the results for usability engineering and risk management files. A product can only be certified in the "conformity assessment procedure" if these documents are available.

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