Name and address of the notified bodies. Responsible for the following products. Horizontal technical competence. Annexes or articles of the directives. Limitations (English only).
The Commission strives to maintain an up-to-date list of bodies notified by EU countries and make the necessary information available to all interested parties.
The lists : include the identification number of . Only bodies that comply with certain criteria regarding competence and independence (typically determined by the national accreditation body can be designated and notified to the European Commission). Lists of EC Type Certificates issued and withdrawn along with Quality Approvals withdrawn are contained in the spreadsheet here. For a list of the notified . Product family, product(Intended use). Technical specification . After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states.
Notified Bodies in the EEA Member States.
A notified body is accredited in its proper EU member state and then notified to a European list of notified bodies (NANDO). A notified body , in the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and.
These information as issued . There are some minor differences in the list for medical devices. User Need: As a company wishing to assess medical devices. I need to apply to become a notified body so that we can assess medical devices and . A product can be covered by several directives. A manufacturer may place a medical device on the European market if it satisfies the legal requirements. For the latest list of notified bodies , visit the European Commission website.
It can be used to determine which NBs fit the desired criteria. LIST OF CONFORMITY ASSESSMENT BODIES. AND PERSONAL WATERCRAFT. The NANDO database lists conformity assessment bodies (CABs) notified by Member States (MS) under technical harmonisation legislation. Visit the public website . The documents provide the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices (Annex I) and IVDs (Annex II).
The International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products. Authorised to perform conformity .
Please be aware that DIBt is responsible for notifying bodies established in Germany only. Application forms (German). Elektrotechnický zkušební ústav, s. List of notified bodies (NANDO list ). Electrotechnical Testing Institute, s. The EU Commission keeps a list of all notified bodies which is published in the Official Journal of the European Communities.