Swedac’s activities include both notified and appointed bodies. Swedacs work is to assess and appoint bodies and to consider requests.

Notified and appointed bodies

Notified bodies

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 to an entity that wishes to become a notified body

An entity that wishes to be appointed as notified body must apply for accreditation for the purpose of notifications using an application form. Swedac then initiates a three-step administrative process.

1. Decision on accreditation for the purpose of notifications

In consultation with the competent authorities, Swedac decides whether the body meets the requirements for the assignment covered by the notification, according to § 7 of the Accreditation and Technical Control Act (2011:791), (LATK). Unless otherwise prescribed, Swedac’s assessment is made by means of accreditation. The first step in the assessment is therefore an accreditation process. When a decision on accreditation has been taken, Swedac’s accreditation department hands the case over to the department at Swedac that deals with applications to be appointed as notified body.

2. Decision on notification

If a body meets the requirements of § 7 of the LATK, Swedac will take the decision to appoint the body. Swedac’s assessment for the decision on notification is preceded by

  • verification that the application has been made, is complete and corresponds to the accreditation decision
  • that the accreditation decision is in accordance with the current legal act, and
  • that consultation has been conducted.

A decision on notification is normally announced within one month. This is provided that there is a complete application, a comprehensive decision on accreditation for the purpose of notifications, and that Swedac has conducted consultation with the responsible sector authority. The decision is sent to the body and a copy of the letter is sent for information purposes to the competent sector authority.

3. Notification to the European Commission and the other Member States

When a decision regarding the notification has been made, Swedac takes the final step in the process, and reports the body to the EU Commission through the Nando database. In turn, the Commission verifies and then notifies the appointment to the other Member States. The Commission’s administration period is outside of Swedac’s influence, but does not normally exceed three weeks.

Once the notification has been published in Nando, the body may act as a notified body.

 

Appointed bodies

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