Directive 93/42/EEC - Conformity Assessment

In order to obtain the CE mark, a process called conformity assessment needs to be carried out by the manufacturer, which aims to demonstrate whether specified requirements relating to a product have been fulfilled.

Conformity assesmenens are defined in Annexes from II to VII of the Medical Devices Directive.

CHOOSE PATH ACCORDING TO MD CLASS

CLASS I

Annex VII

CLASS I s/m

Annex VII + IV

Annex VII + V

Annex VII + VI

CLASS IIa

Annex VII + IV

Annex VII + V

Annex VII + VI

Annex II (ex.4)

CLASS IIb

Annex III + IV

Annex III+ V

Annex III+ VI

Annex II (ex. 4)

CLASS III

Annex III + IV

Annex III+ V

Annex II

Now it's time to chose the Notified Body.

Notified Body

Notified bodies re defined as conformity assessment bodies which have been officially designated by their national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required. Only bodies that comply with certain criteria regarding competence and independence can be designated and notified to the European commission. It must operate in a non-discriminatory, neutral, transparent, impartial and independent manner.

Notified bodies carry the following tasks: product certification, factory production control certification or determination of the product-type on the basis of type testing. It is true that a NB is not always necessary as it depends on the chosen module (as it happens in Class I medical devices, non-sterile and non-measuring).

Manufacturers can choose which Notified Body may verify the compliance assessment of its given product. Any accredited NB established in any EU Member State (independently of the manufacturer’s country) can be chosen,

CHOOSE NOTIFIED BODY

Choose a Notified Body taking into account:

The Class of the device
The CODE of the device
The Conformity Assessment
Experience

It is recommended to take into account not only the current device but future devices.

To do so, use the table below. Use the search tool bar to reduce the table.

The table in Excel format enables the user to filter each column. Download it now.

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