Notified bodies – are independent organisations that assist and monitor manufacturers’ efforts to verify that products comply with EU regulations. This is achieved by testing, inspection and certification in accordance with EU legislation.
Identification of a notified body rises from a member state notifying the approved organisations to the European Commission, which in turn assigns each notified inspection a four-digit identification number and publishes the name and address in the Commission’s magazine, the Official Journal (OJ). For a list of the notified bodies working in various fields, see the European Commission’s public database Nando.
Swedac is the national notifying authority of Sweden. This means that Swedac assesses and designates bodies after consultation with the relevant authorities, and then notifies the bodies to the EU Commission. Swedac also exercises oversight of notified bodies, in cooperation with each competent sector authority.
Information on the competent sector authorities is compiled and available on the Market Surveillance Council website.
Information for those who want to be notified bodies
Swedac’s assessment of competence of a notified body is performed through accreditation, unless otherwise prescribed. An assessment is made against a number of requirements and guidance documents, of which STAFS 2011: 5 and STAFS 2015: 6 are two of the requirements documents for accreditation. One of the guidance documents applicable is EA-2/17.
The application to be appointed as notified body and the accreditation application for notification purposes is made using application form AO. According to § 7 Act (2011: 791) on Accreditation and Conformity Assessment, Swedac will in consultation with the relevant authorities determine whether the body meets the requirements of the task to which the notification relates. This means that Swedac will inform the competent sector authority on an application as well as during the accreditation process. In some cases, a simplified consultation procedure is applied.
When the accreditation process is complete and there are accreditation decisions to be made, Swedac conducts consultation on notification with the competent sector authority. If a body fulfils the requirements of § 7 LATK, Swedac makes a decision to appoint the body, then reports it to the European Commission and the other member states. Registration is by means of the database Nando.
The last step in Swedac’s processing takes place after the notification is published in Nando.
Swedac then sends a letter to the notified body with information that it is now allowed to act as a notified body, the decision on the notification, excerpts from Nando showing the publication and the decision on accreditation. A copy of the letter will also be sent to the competent sector authority for information.
The European Commission’s website contains certain regulations and a description of Swedac’s process for accreditation and registration. There is also clarification about which control standards apply for he accreditation.
Appointed bodies in the EU test and certify products to be placed on the market in the countries which have concluded agreements with the EU on mutual recognition. These agreements are often called MRA which is an abbreviation of the English Mutual Recognition Agreement. The agreements regulate the conditions under which the test reports and certificates are accepted between the EU and the other contracting party.
Appointed bodies are appointed by the EU member states. The European Commission will then forward this to the country with which the EU has concluded agreements.
A non-European manufacturer wishing to export its products to the EU may allow an appointed body in its homeland to test and certify its products. The products are tested and certified according to the rules that apply in the EU.
In Sweden it is Swedac that reviews applications to become designated bodies. Those who wish to be appointed must meet the competency requirements as set out by the law of the country in which the EU has mutual agreements with MRA.
A list of current MRA agreements and the inspection bodies notified by the EU member states is found in Nando.
Bodies may also be appointed to perform tasks such as testing under free trade agreements. Such agreements are often called FTA, which is an abbreviation of Free Trade Agreement. So far, Swedac has one notified body under the FTA with South Korea. A list of the bodies notified by countries in the EU to test products to be exported to South Korea is available here