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Art. 47a

812.21TPAFederal ActJan 1, 2002Original source
  1. The manufacturer must produce technical documentation.
  2. The technical documentation must be such as to permit an assessment of the conformity of the medical device with the requirements of this Act. In particular, it shall also contain information and data on post-market surveillance.
  3. The manufacturer must keep the technical documentation up to date.
  4. The Federal Council shall specify for what medical devices what data and information must be included in the technical documentation, and how this documentation must be made available.

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