EU-US trade talks: EU proposal for the EU – U.S. agreement on conformity assessment

Posted on 04.12.2019

The European Commission has published its proposal for the EU – U.S. agreement on conformity assessment, which has been tabled for discussion with the U.S. The final text of the agreement will be the outcome of negotiations between the EU and the U.S. the Commission proposal and background documents can be found on the DG TRADE website.

The Commission proposal includes provisions concerning medical devices i.e., pertaining to use of the results of conformity assessment by the authorities. The proposal states that each party shall consider quality system evaluation reports prepared by conformity assessment bodies established under the MDSAP (see article 14 of the proposal). The proposal further evaluates circumstances which could justify that a report is not taken into consideration, which include: “… indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing Party may request clarification from the exporting Party, which may lead to a request for reinspection.”

For more information, contact j.rueda@medtecheurope.org and d.kanecka@medtecheurope.org .