Eudamed

Peter made this access to documents request to Health and Food Safety

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The request was partially successful.

Dear Madam, Sir,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

- All progress reports about the European database on medical devices (‘Eudamed’) that the Commission is required to set up due to article 33 of Regulation (EU) 2017/745

- All e-mails (including any attachments) between DG SANTE and other DG's about the development of Eudamed

- All documents related to the decision to delay deployment of Eudamed until 2022

Sincerely,
Peter Teffer

postal address:
Peter Teffer
Ekko Voorkamer
Bemuurde Weerd WZ 3
3513 BH Utrecht
The Netherlands

Health and Food Safety

Dear Sir,

 

Thank you for your e-mail of 4 June 2020. We hereby acknowledge receipt of
your application for access to documents, which was registered on 5 June
2020 under reference number GESTDEM 2020/3409.

 

In accordance with Regulation (EC) No 1049/2001 regarding public access to
European Parliament, Council and Commission documents, your application
will be handled within 15 working days. The time limit will expire on 26
June 2020. In case this time limit needs to be extended, you will be
informed in due course.

 

You have lodged your application via a private third-party website, which
has no link with any institution of the European Union. Therefore, the
European Commission cannot be held accountable for any technical issues or
problems linked to the use of this system.

 

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Yours faithfully,

Access to Documents Team

 

References

Visible links
1. https://ec.europa.eu/info/principles-and...

ve_sante.b.6(SANTE), Health and Food Safety

2 Attachments

Please find attached document Ares(2020)3296012 from AMPELAS Anna Eva (SANTE.DDG1.B.6) dated 24/06/2020.

According to standard operational procedure, the reply is usually also sent to you by registered post. Please note, however, that due to the extraordinary health and security measures currently in force during to the COVID-19 epidemics, which include the requirement for all Commission non-critical staff to telework, we are unfortunately not in a position to follow this procedure until further notice.

We would therefore appreciate if you could confirm receipt of the present e-mail by replying to [email address]

Dear Mrs Ampelas,

Thank you for your e-mail requesting to reach a fair solution regarding my access to documents request registered on 5 June 2020 under GESTDEM 2020/3409, to make handling it more manageable.

Regarding point 1, I can accept the limitation of progress reports communicated to Member States, but would like to receive a description or list of documents that as a consequence will not be included.

Regarding point 2, the transfer of competence of the development of EUDAMED from the Director General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) to DG SANTE is one of my interests. I therefore propose to limit the temporal scope of this point of my request from 1 January 2019 to January 2020. I would also be satisfied with a limitation of only all e-mails (including any attachments) between DG SANTE and DG GROW, and not any other DG's. That should sufficiently limit the time needed to organise the documents related to point 2.

All the best,
Peter Teffer

Dear Madam, Sir,

I refer to my application for access to documents which was registered under GESTDEM 2020/3409.

I accepted a limitation in the scope of my request in order to reach a fair solution, so that the Commission would be able to achieve handling the request within the extended deadline of 15 + 15 working days. The fact that a fair solution was proposed gave the impression that I could expect a response within that deadline.

Sadly, I have to remind you that this extended deadline has now passed and legally the Commission should have responded by now.

Hoping to receive a response without further delay,
Peter Teffer

Health and Food Safety

1 Attachment

Dear Mr Teffer,

 

Thank you for your e-mail  of 20 July regarding the request for access to
documents GestDem 2020/3409, which has been registered under the reference
number Ares(2020)2919009.

 

We would like to inform you that we are working on finalising your request
and hope to complete it as soon as possible. Despite the fair solution,
the request still requires the Commission to identify documents from among
a large volume of files originating from different departments within the
Commission.

 

We hope for your understanding and apologise for any inconvenience this
may cause.

 

 

Kind regards,

 

Anna-Eva AMPELAS

Head of Unit

[1]cid:image001.gif@01D16FDF.FD8F6B80
European Commission
Directorate-General for Health and Food Safety (DG SANTE)
Unit B.6 - Medical Devices

F101 08/58
1049 Brussels, Belgium

[2][email address]

 

 

show quoted sections

ve_sante.b.6(SANTE), Health and Food Safety

66 Attachments

Please find attached document Ares(2020)4102167 from BUCHER Anne (SANTE) dated 04/08/2020.

Veuillez trouver ci-joint le document Ares(2020)4102167 de BUCHER Anne (SANTE) daté du 04/08/2020.

According to standard operational procedure, the reply is usually also sent to you by registered post. Please note, however, that due to the extraordinary health and security measures currently in force during to the COVID-19 epidemics, which include the requirement for all Commission non-critical staff to telework, we are unfortunately not in a position to follow this procedure until further notice.

We would therefore appreciate if you could confirm receipt of the present e-mail by replying to [email address]