The Commission`s proposal contains provisions relating to medical devices, i.e. the use by the authorities of the results of the compliance assessment. The proposal specifies that each party reviews quality assurance system evaluation reports prepared by compliance assessment agencies established under the MDSAP (see Article 14 of the proposal). The proposal also assesses the circumstances that might justify not taking into account a report, including: “… references to significant inconsistencies or inadequacies in a report, quality deficiencies found during post-market monitoring, or other specific indications of serious concerns about product quality or consumer safety. In such cases, the importing party may ask the exporting party to provide clarification that could give rise to a request for reconsideration.” The European Commission today published its proposal for an agreement between the EU and the United States on the assessment of the compliance of industrial products, in line with its commitment to greater transparency in trade negotiations. Context Compliance Assessment is the process of verifying a product`s compliance with all legal requirements to be sold in a given country. It ensures that the product is safe and compliant with the applicable rules. Joint eu-US compliance assessment work was one of the measures agreed in the EU-US Joint Declaration of 25 July 2018.
On 15 April 2019, the Council of the European Union adopted a decision authorising the opening of negotiations for a compliance assessment agreement with the United States. More information The EU proposal is for an agreement under which the EU and the US accept the compliance assessment results of other compliance assessment bodies and certify the products in accordance with the legal requirements of the other party. This would allow exporters to apply for certification of their products in their home countries. The proposal covers all relevant industrial sectors in which both parties must be subject to a third-party compliance assessment. In addition, the EU proposal addresses the difficulties faced by European exporters of electrical and electronic machinery and equipment in certifying products sold in the US market. A product exported between the two parties often needs to be evaluated to demonstrate compliance with the technical and safety requirements of the importing party, known as a “compliance assessment.” This often involves additional costs for exporters, which is particularly distressing for small businesses, which often choose not to export at all because of these costs and complexities.