Eudamed - Public Access - Directive 2007/47/EC preamble

[Ronen E]

Hello all,

The following text appears in Directive 2007/47/EC preamble (emphasis not in the source):

(16) In support of transparency in Community legislation, certain information related to medical devices and
their conformity with Directive 93/42/EEC, in particular information on registration, on vigilance reports and
on certificates, should be available to any interested party and the general public.

Yet an official European Commission Consumer Affairs webpage (http://ec.europa.eu/consumers/sector...lance/eudamed/) states (emphasis in source):

Who can access Eudamed?

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed use is obligatory since May 2011.

Can someone kindly shed some light on this, and maybe some prospects for the future?


Ronen.

[Marc]

A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!

[pkost]

Eudamed has been created in response to article 14a - European databank

The requirement for a european databank predates the 2007 version of the directive which introduced changes to article 20 regarding confidentiality. Before 2007 pretty much everything was confidential and could not be made public by the CA's...

In Reply to Parent Post by Article 20 (pre 2007)

Without prejudice to the existing national provisions and practices on medical secrets, member stats shall ensure that all the parties involved in the application of this directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks. This does not affect the obligation of member states and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law

.

The updated version contains a much more relaxed view to confidentiality:

In Reply to Parent Post by Article 20 (post 2007)

1. Without prejudice to the existing national provisions and practices
on medical confidentiality, Member States shall ensure that all the
Parties involved in the application of this Directive are bound to
observe confidentiality with regard to all information obtained in
carrying out their tasks.
This does not affect the obligation of Member States and notified bodies
with regard to mutual information and the dissemination of warnings,
nor the obligations of the persons concerned to provide information
under criminal law.
2. The following information shall not be treated as confidential:
(a) information on the registration of persons responsible for placing
devices on the market in accordance with Article 14;
(b) information to users sent out by the manufacturer, authorised representative
or distributor in relation to a measure according to
Article 10(3);
(c) information contained in certificates issued, modified, supplemented,
suspended or withdrawn.

3. The measures designed to amend non-essential elements of this
Directive, inter alia by supplementing it, relating to determination of the
conditions under which other information may be made publicly
available, and in particular for Class IIb and Class III devices to any
obligation for manufacturers to prepare and make available a summary
of the information and data related to the device, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in
Article 7(3).

I would imagine that it would be quite an undertaking to change EUDAMED from a closed system into one which the public can access.