MDCG 21 March

Peter made this Informationsfreiheit request to Gesundheit und Lebensmittelsicherheit

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Ihre Anfrage war teilweise erfolgreich.

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:

- The minutes, both internal and public, of the 21-22 March 2022 meeting of the Medical Device Coordination Group, in particular about the recall case involving Philips Respironics

- All e-mails sent by members of the Medical Device Coordination Group, about Philips Respironics

- All presentations given and other documents shared by participants in the MDCG about Philips Respironics

Sincerely,
Peter Teffer

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

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Sir / Madam,

 

Thank you for your e-mail of 22 March 2022. We hereby acknowledge receipt
of your application for access to documents, which was registered on the
same date under reference number GESTDEM 2022/1665.

 

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 12
April 2022. 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.

 

Please note that the private third party running the AsktheEU website is
responsible and accountable for the processing of your personal data via
that website, and not the Commission. For further information on your
rights, please refer to the third party’s privacy policy.

 

We understand that the third party running the AsktheEU.org website
usually publishes the content of applicants’ correspondence with the
Commission on that website. This includes the personal data that you may
have communicated to the Commission (e.g. your private postal address).

 

Similarly, the third party publishes on that website any reply that the
Commission will send to the email address of the applicants generated by
the AsktheEU.org website.

 

If you do not wish that your correspondence with the Commission is
published on a private third-party website such as AsktheEU.org, you can
provide us with an alternative, private e-mail address for further
correspondence.  In that case, the Commission will send all future
electronic correspondence addressed to you only to that private address,
and it will use only that private address to reply to your request. You
should still remain responsible to inform the private third-party website
about this change of how you wish to communicate with, and receive a reply
from, the Commission.

 

For information on how we process your personal data visit our page
[1]Privacy statement – access to documents.

 

Yours faithfully,

 

SANTE ACCESS TO DOCUMENTS

[2]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

 

Zitate anzeigen

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Sir/Madam,

 

We refer to your request dated 22 March 2022 in which you make a request
for access to documents, registered on the same date under the above
mentioned reference number.

 

Your application is currently being handled. However, we will not be in a
position to complete the handling of your application within the time
limit of 15 working days, which expires today on 12 April 2022.

 

An extended time limit is needed as part of the documents requested
originate from third parties which have been consulted.

 

Therefore, we have to extend the time limit with 15 working days in
accordance with Article 7(3) of Regulation (EC) No 1049/2001 regarding
public access to documents. The new time limit expires on 6 May 2022.

 

We apologise for this delay and for any inconvenience this may cause.

 

Yours faithfully,

 

 

SANTE ACCESS TO DOCUMENTS

[1]cid:image001.gif@01D3FF48.374A49E0
European Commission
Health and Food Safety

 

 

References

Visible links

Dear Madam, Sir,

I write to you in reference to access to documents application GESTDEM 2022/1665, and your message on 12 April 2022 stating your inability to complete the handling of my application within the legal time limit of 15 working days.

I don't believe this extension is in line with both letter and spirit of Regulation 1049/2001. Article 7 explicitly states that an extension is only allowed in "exceptional cases, for example in the event of an application relating to a very long document or to a very large number of documents".

The need to consult a third party is everything but exceptional: the Regulation itself mentions the need to consult with third parties.

If the consultation process with third parties is not yet complete, this means that the European Commission has either a) not provided the third parties with a deadline that takes into account the need for the Commission to reply within 15 working days, or b) the third party missed such a deadline. In the first case (a), the Commission is responsible for having omitted such a deadline when it sent its consultation request. In the second case (b), it can be argued the Commission should proceed without the third party's consultation, since it is the Commission that is accountable for replying within 15 working days.

Additionally, such extension of the deadline is only allowed under Regulation 1049/2001 when "detailed reasons are given".

The mere reference to the need to consult third parties - which itself is not exceptional and thus not a qualified reason for an extension - can not be considered as "detailed reasons" for this delay.

I thus invite DG Sante to provide the documents without any additional delay, since there is no legal basis for it.

Sincerely,
Peter Teffer

SANTE CONSULT-B6, Gesundheit und Lebensmittelsicherheit

9 Attachments

  • Attachment

    7 Ares 2022 3271353 RE March 21st 2nd MDCG agenda additional topic Philips French decision Redacted II Redacted.pdf

    120K Download View as HTML

  • Attachment

    5 Ares 2022 1657218 Annex 20220209 DPS Philips jlds09022022 EN relu.pdf

    406K Download View as HTML

  • Attachment

    4 Ares 2022 1657218 March 21st 2nd MDCG agenda additional topic Philipps French decision Redacted II Redacted.pdf

    94K Download View as HTML

  • Attachment

    3 Ares 2022 730849 Message to MDCG Redacted II Redacted.pdf

    178K Download View as HTML

  • Attachment

    Partial positive reply Gestdem 2022 1665.pdf

    207K Download View as HTML

  • Attachment

    2 Ares 2022 100546 Annex PHILIPS D cision de Police Sanitaire 09 02 2022 Redacted.pdf

    5.2M Download View as HTML

  • Attachment

    List of documents Gestdem 2022 1665.pdf

    445K Download View as HTML

  • Attachment

    1 Ares 2022 1005467 Message to MDCG and Philips TF under PMSVWG Redacted II Redacted.pdf

    201K Download View as HTML

  • Attachment

    6 Ares 2022 1657218 Annex 2 PHILIPS D cision de Police Sanitaire 09 02 2022 Redacted.pdf

    5.2M Download View as HTML

Dear Mr Teffer,
please find attached a reply to your request for documents.

With kind regards
Daniela Marullo

SANTE MED DEV SECRETARIAT

Dear Madam, Sir,

Thanks for your reply to my access to documents request registered under reference number GESTDEM 2022/1665. Please pass this on to the person responsible for handling confirmatory applications.

I had asked for, inter alia:

- The minutes, both internal and public, of the 21-22 March 2022 meeting of the Medical Device Coordination Group, in particular about the recall case involving Philips Respironics

The list of documents accompanying your reply suggests that these documents do not exist. This is not possible. The MDCG terms of reference clearly states that there should be "meaningful and complete" minutes and that these minutes should be published "timely".

While it is possible that the minutes are still not approved for publication on the MDCG website, that does not waive the Commission of the responsibility to determine whether it can publish draft versions of those minutes when a citizen asks for them under Regulation 1049/2001 - as I have done.

I therefore request that you re-examine my request and publish all versions of the minutes of the said meeting.

Sincerely
Peter Teffer

SG ACCES DOCUMENTS, Gesundheit und Lebensmittelsicherheit

1 Attachment

Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping

Dear Sir,

 

Thank you for your email dated 9/05/2022 by which you request, pursuant to
Regulation No 1049/2001 regarding public access to European Parliament,
Council and Commission documents, a review of the position taken by DG
SANTE in reply to your initial application GESTDEM 2022/1665.

 

We hereby acknowledge receipt of your confirmatory application for access
to documents which was registered on 11/05/2022 ([5]Ares(2022)3591359).

 

Your application will be handled within 15 working days (03/06/2022). In
case this time limit needs to be extended, you will be informed in due
course.

 

Please be informed that the answer to your confirmatory application is a
formal Commission decision that will be notified to you by express
delivery. Thank you for providing your contact phone number, so that the
external delivery service can contact you in case of absence.

 

Please note that the Commission will not use your phone number for any
other purpose than for informing the delivery service, and that it will
delete it immediately thereafter.

 

Yours faithfully,

 

 

 

ACCESS TO DOCUMENTS TEAM (IC)

 

 

European Commission

Secretariat-General

SG.C1 (Transparency, Document Management and Access to Documents)

[6][email address]

 

 

 

Zitate anzeigen

Sg-Acc-Doc@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Mr Teffer,

 

I refer to your email of 9 May 2022, registered on 11 May 2022, by which
you submitted a confirmatory application in accordance with Article 7(2)
of Regulation (EC) No 1049/2001 regarding public access to European
Parliament, Council and Commission documents ("Regulation (EC) No
1049/2001"), registered under the reference number above.

 

The confirmatory decision in response to your application is in the
process of being internally approved.

 

However,  we will not be in a position to reply to your confirmatory
request within the prescribed time limit which expires on 3 June 2022.
Consequently, we have to extend this period by another 15 working days in
accordance with Article 8(2) of Regulation (EC) No 1049/2001. The new
deadline expires on 27 June 2022.

 

I regret this additional delay and sincerely apologise for any
inconvenience this may cause. However, I can assure you that we are doing
our utmost to provide you with a final reply as soon as possible.

 

Yours sincerely,

 

Mariusz Daca, Ph.D.
Deputy Head of Unit
[1]cid:image001.gif@01D13362.41D673C0

European Commission

Secretariat General

Unit C.1 (Transparency, Document Management and Access to Documents)

 

 

References

Visible links

Dear Madam, Sir,

I refer to my confirmatory application for access to documents, registered on 11 May 2022 under Ares(2022)3591359 (related to GESTDEM 2022/1665).

This is a kind reminder of the fact that the extended time limit - only allowed in exceptional cases - to reply expires today.

Since you informed me on 3 June 2022 that the decision was "in the process of being internally approved", I hope and expect to receive the final decision today.

Sincerely,
Peter Teffer

SG ACCES DOCUMENTS, Gesundheit und Lebensmittelsicherheit

[1]holding letter - 2022-1665 - Ares(2022)4711751  (Please use this link
only if you are an Ares user – Svp, utilisez ce lien exclusivement si vous
êtes un(e) utilisateur d’Ares)

Dear Mr Teffer,

Thank you for your email.

Please note that the decision is in the process of being finalised. We
expect that it will be send to you as soon as possible. 

Please accept our apologies for this delay and for any inconvenience it
might cause to you.

Kind regards,

Access to documents team (cr)
SG.C.1
Transparency

Zitate anzeigen

SG-GREFFE-CERTIFICATION@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

3 Attachments

Dear Sir Peter Teffer,

 

Please find attached the electronic version of Commission Decision
C(2022)4818 as adopted by the European Commission on 3.7.2022.

 

The formal notification of the decision under Article 297 TFEU is being
made only in electronic form.

 

Could you please confirm receipt of the attached document by return
e-mail?

 

Many thanks in advance.

 

 

BEVIERE Chantal

 

European Commission

Secrétariat général de la Commission – SG - B-2
Procédures écrites, d’habilitation et de délégation

B-1049 Brussels/Belgium

+32 2-295.77.42

[1][email address]

 

 

  

 

 

 

From: SG GREFFE CERTIFICATION <[email address]>
Sent: Monday, July 4, 2022 2:53 PM
To: ask <[email address]>
Cc: MORINI Belinda (SG) <[email address]>
Subject: C(2022) 4818 - Ekko Voorkamer

 

Dear Sir Peter Teffer,

 

Please find attached the electronic version of Commission Decision
C(2022)4818 as adopted by the European Commission on 3.7.2022.

 

The formal notification of the decision under Article 297 TFEU is being
made only in electronic form.

 

Could you please confirm receipt of the attached document by return
e-mail?

 

Many thanks in advance.

 

Kind regards,

 

BEVIERE Chantal

 

European Commission

Secrétariat général de la Commission – SG - B-2
Procédures écrites, d’habilitation et de délégation

B-1049 Brussels/Belgium

+32 2-295.77.42

[2][email address]

 

 

  

 

 

 

 

References

Visible links
1. mailto:[email address]
2. mailto:[email address]

SG-GREFFE-CERTIFICATION@ec.europa.eu, Gesundheit und Lebensmittelsicherheit

1 Attachment

Dear Mr, Ms

 

It is very important for us.

 

Please, could you please acknowledge the receipt of the document enclosed
in the message addressed to you

BEVIERE Chantal

 

European Commission

Secrétariat général de la Commission – SG - B-2
Procédures écrites, d’habilitation et de délégation

B-1049 Brussels/Belgium

+32 2-295.77.42

[1][email address]

 

 

  

 

 

 

From: SG GREFFE CERTIFICATION <[email address]>
Sent: Thursday, July 7, 2022 9:54 AM
To: [FOI #10874 email]
Cc: MORINI Belinda (SG) <[email address]>
Subject: C(2022) 4818 - Ekko Voorkamer

 

Dear Sir Peter Teffer,

 

Please find attached the electronic version of Commission Decision
C(2022)4818 as adopted by the European Commission on 3.7.2022.

 

The formal notification of the decision under Article 297 TFEU is being
made only in electronic form.

 

Could you please confirm receipt of the attached document by return
e-mail?

 

Many thanks in advance.

 

 

BEVIERE Chantal

 

European Commission

Secrétariat général de la Commission – SG - B-2
Procédures écrites, d’habilitation et de délégation

B-1049 Brussels/Belgium

+32 2-295.77.42

[2][email address]

 

 

  

 

 

 

From: SG GREFFE CERTIFICATION <[3][email address]>
Sent: Monday, July 4, 2022 2:53 PM
To: ask <[4][email address]>
Cc: MORINI Belinda (SG) <[5][email address]>
Subject: C(2022) 4818 - Ekko Voorkamer

 

Dear Sir Peter Teffer,

 

Please find attached the electronic version of Commission Decision
C(2022)4818 as adopted by the European Commission on 3.7.2022.

 

The formal notification of the decision under Article 297 TFEU is being
made only in electronic form.

 

Could you please confirm receipt of the attached document by return
e-mail?

 

Many thanks in advance.

 

Kind regards,

 

BEVIERE Chantal

 

European Commission

Secrétariat général de la Commission – SG - B-2
Procédures écrites, d’habilitation et de délégation

B-1049 Brussels/Belgium

+32 2-295.77.42

[6][email address]

 

 

  

 

 

 

 

References

Visible links
1. mailto:[email address]
2. mailto:[email address]
3. mailto:[email address]
4. mailto:[email address]
5. mailto:[email address]
6. mailto:[email address]

Dear Mrs Beviere,

I confirm receipt of Commission Decision C(2022)4818.

Sincerely,
Peter Teffer