SRPS CR 14060:2013

Medical device traceability

Scope

This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.
It is understood that the procedures to be described in this report will be more detailed in relation to high-risk devices when the need has been identified to trace devices as far as the actual patient.

For lower risk devices this report provides recommendations for elements of procedures to be transmitted by manufacturers to the members of a distribution chain, to achieve an appropriate level of traceability, perhaps of batches of products in some cases, sufficient to withdraw or inform purchasers or users of information regarding such identified products.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.