External PRRC

To comply with regulations


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Qualified experts, a customized solution

The regulations allow small companies (within the meaning of Recommendation 2003/361/EC) to outsource the function of the Person Responsible for Regulatory Compliance (PRRC).
If you are a medical device manufacturer, MD101 can provide you with a person who has the skills and experience required to carry out the necessary checks and monitoring:

  • The permanent availability of the PRRC by assigning you a team of three people (one permanent and two substitutes).
  • Obligations concerning clinical investigations are fulfilled.
  • Obligations concerning vigilance notifications are fulfilled.
  • Technical documentation and EU declaration of conformity are established and kept upto-date.
  • Device compliance is ensured.
  • Post-marketing surveillance obligations are met.

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