Harmonised standards
Dear Secretariat General of the European Commission,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001 and interpreted by the Court in the recent decision of 5 March 2024, C‑588/21 P, I am requesting documents which contain the following information:
The povision of all harmonised standards, since those standards form part of EU law owing to their legal effects.
Yours faithfully,
Alexander Schmalenberger
Taylor Wessing Partnerschaftsgesellschaft mbB
Hanseatic Trade Center
Am Sandtorkai 41
20457 Hamburg
Dear Sir or Madam,
We hereby acknowledge the receipt of your request for access to documents
sent on 06/03/2024 and registered on 07/03/2024 under the case number
2024/1288.
We will handle your request within 15 working days as of the date of
registration. The time-limit expires on 02/04/2024. We will let you know
if we need to extend this time limit for additional 15 working days.
To find more information on how we process your personal data, please see
[1]the privacy statement.
Yours faithfully,
Secretariat-General - Access to Documents
European Commission
References
Visible links
1. https://ec.europa.eu/info/principles-and...
Dear Sir,
Please find attached a message concerning your request for access to
Commission documents registered under the above case number 2024/1288.
Kind regards,
DG GROW ATD Team
Dear Secretariat General of the European Commission,
thank you for your answer. The documents requested are all listed on the follwoing website and it subsites:
https://single-market-economy.ec.europa....
Yours faithfully,
Alexander Schmalenberger
Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...
Dear Secretariat General of the European Commission,
I would also be content if you could simply provide the harmonised standards for download on the website I provided the link for.
Yours faithfully,
Alexander Schmalenberger
Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...
Dear Secretariat General of the European Commission,
I am writing to inquire about the progress of my request for access to documents, which was submitted on 6 March 2024. While I have received an acknowledgment of receipt, I have yet to receive any substantive response or documents.
The request pertains to the provision of all harmonised standards, as these are integral to EU law due to their legal effects, under the right of access to documents in the EU treaties, Regulation 1049/2001, and in light of the Court’s interpretation in the decision of 5 March 2024, C‑588/21 P.
Given the importance of these documents for my ongoing projects, I would greatly appreciate an update on the status of my request or any indicative timeline for the processing of the same.
Thank you for your attention to this matter, and I look forward to your prompt response.
Yours faithfully,
Alexander Schmalenberger
Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...
Dear Mr. Schmalenberger,
We refer to your request for access to documents, registered on 07/03/2024
under the above mentioned reference number.
Your application is currently being handled. However, we were in a
position to complete the handling of your application within the time
limit of 15 working days, which expired on 16/04/2024.
An extended time limit is needed as in order to retrieve the documents
requested, large files have to be examined;
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 08/05/2024.
We apologize for this delay and for any inconvenience this may cause.
Yours sincerely,
DG GROW – Access to documents team
European Commission
Directorate-General for Internal Market, Industry, Entrepreneurship and
SMEs
DG GROW/B1 – Planning and Briefings
Link: [1]File-List
Link: [2]Edit-Time-Data
Link: [3]themeData
Link: [4]colorSchemeMapping
[5]Your Access to Documents request under reference EASE 2024/1288 -
Ares(2024)3338316 (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 Schmalenberger,
We refer to your email of 23 April 2024 in which you clarify the scope of
your request for access to documents, registered in the
Directorate-General for the Internal Market, Industry, Entrepreneurship
and SMEs (DG GROW) under the reference EASE 2024/1288.
You request access to all documents related to all harmonised standards.
We would like to inform you that, under Article 6(3) of Regulation (EC) No
1049/2001, your application concerns non-verifiable amount of documents
considering the large, temporal, and broad scope of your request.
The work needed for this request entails multiple steps:
• Establishment of a complete list of the documents
falling under the scope of your request;
• Retrieval of all identified document files and
their processing for the purpose of your request;
• Assessment of the further procedural steps to
undertake;
• (possibly) third-party consultations under Article
4(4) of Regulation 1049/2001 and (possibly) a further dialogue with the
third-party originators of documents falling within the scope of your
request;
• Final assessment of the documents in light of the
comments received, including of the possibility of granting (partial)
access;
• Eventual redactions of the relevant parts falling
under exceptions of Regulation (EC) No 1049/2001;
• Preparation of the draft reply;
• Finalisation of the reply at administrative level
and formal approvals of the draft decision;
• Final check of the documents to be (partially)
released (if applicable) (scanning of the redacted versions,
administrative treatment, etc.) and dispatch of the reply.
The completion of these steps regarding a very large number of documents,
which we have estimated, at this stage, to be around 8000 separate
document files and broad scope, cannot be expected to be completed within
the normal time limits set out in Article 8 of Regulation (EC) No
1049/2001.
As stated by the EU Courts, the European Commission needs to respect the
principle of proportionality and ensure that the interest of the applicant
for access is balanced against the workload resulting from the processing
of the application for access in order to safeguard the interests of good
administration. Article 6(3) of Regulation (EC) No 1049/2001 provides that
in the event of an application relating to a very long document or to very
large number of documents, the institution concerned may confer with the
applicant informally, with a view to finding a fair solution.
In accordance with the case law of the EU Courts, a fair solution can only
concern the content or the number of documents applied for, not the
deadline for replying. This means that the scope of your requests must be
reduced in a way that would enable its treatment within the extended
deadline of 15 + 15 working days.
According to our estimates on the workload and the length and complexity
of processing documents at stake, it would seem that the
Directorate-General for Internal Market, Industry and SMEs (DG GROW) would
be able to handle approximately 15 to 20 harmonised standards, counting
from your reply to our proposal for a fair solution.
To this end, we ask you to specify the objective of your wide-scoped
request, your specific interest in the documents requested, and to narrow
down the scope of your request by providing an exact list of harmonised
standards of interest, to reduce it to a more manageable number.
In order to enable us to respect the time-limits of Regulation (EC) No
1049/2001, we would ask you for a swift reply to our invitation to this a
fair solution proposal, within five working days at the latest.
In the absence of a reply within five working days, we will unilaterally
restrict the scope of your application to those parts that can be dealt
with within the extended deadline.
Thank you in advance for your understanding.
DG GROW – Unit H3 – Standards Policy
European Commission
Directorate-General for Internal Market, Industry, Entrepreneurship and
SMEs
Directorate H – Ecosystems III – Construction, Machinery and
Standardisation
Unit H3 – Standards Policy
References
Visible links
1. file:///tmp/cid:filelist.xml@01DAA0A5.5D7270C0
2. file:///tmp/cid:editdata.mso
3. file:///tmp/~~themedata~~
4. file:///tmp/~~colorschememapping~~
5. https://webgate.ec.testa.eu/Ares/documen...
Dear GROW H3,
Dear Sir/Madam,
Thank you for your detailed response regarding my request for access to documents related to harmonised standards, registered under reference EASE 2024/1288.
I understand the extensive scope of my original request and appreciate the challenges associated with processing a large volume of documents. To facilitate a more manageable request and to align with the principle of proportionality, I am providing a specific list of harmonised standards that are of primary interest to me.
I kindly request access to the following harmonised standards:
EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14971:2019 - Medical devices - Application of risk management to medical devices
EN ISO 11607-1:2020 - Packaging for terminally sterilised medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 11607-2:2020 - Packaging for terminally sterilised medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
EN ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN ISO 11135:2014 - Sterilisation of health-care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilisation process for medical devices
EN ISO 11137-1:2015 - Sterilisation of health-care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices
EN ISO 11137-2:2015 - Sterilisation of health-care products - Radiation - Part 2: Establishing the sterilisation dose
EN ISO 15223-1:2021 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
EN ISO 17664-1:2021 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
EN ISO 25424:2019 - Sterilisation of health-care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilisation process for medical devices
EN ISO 11737-1:2018 - Sterilisation of health-care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2:2020 - Sterilisation of health-care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilisation process
EN ISO 10993-12:2021 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
EN ISO 10993-10:2023 - Biological evaluation of medical devices - Part 10: Tests for skin sensitisation
EN ISO 10993-15:2023 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
EN ISO 10993-17:2023 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
EN ISO 10993-18:2020 - Biological evaluation of medical devices - Part 18: Chemical characterisation of medical device materials within a risk management process
EN ISO 10993-9:2021 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
EN ISO 285:2015+A1:2021 - Sterilisation - Steam sterilizers - Large sterilizers
I hope this narrowed scope will allow for a more efficient processing of my request within the extended deadlines specified in Regulation (EC) No 1049/2001. Please let me know if further adjustments are needed or if there are any additional steps required on my part.
Thank you for your cooperation and understanding.
Yours sincerely,
Alexander Schmalenberger
SUBJECT: Your application for access to documents – Harmonised standards
medical devices – Ref. EASE No 2024/1288
Dear Mr Schmalenberger,
After the arrangement for a fair solution to your request registered on 6
March 2024 under case number 2024/1288, the competent services of the
European Commission are managing the access to the documents related to
harmonised standards which references are published in the OJEU in support
of Regulation (EU) 2017/745 on medical devices.
Please note that the work needed for your request entails multiple steps:
- establishment of a complete list of the documents falling under
the scope of your request;
- retrieval of all identified document files and their processing
for the purpose of your request;
- assessment of the further legal and procedural steps to
undertake, in light of the applicable legal provisions, in particular
Regulation (EC) No 1049/2001 on public access to European Parliament,
Council and Commission documents, as well as the EU copyright legislation;
- third-party consultations under Article 4(4) of Regulation
1049/2001 and further dialogue with the third parties originators and
copyright-owners of the documents falling within the scope of your
request;
- final assessment of the documents in light of the comments
received, including the possibility of granting (partial) access;
- eventual redaction of the relevant parties falling under
exceptions of Regulation 1049/2001;
- preparation of the draft reply;
- finalization of the reply at administrative level and formal
approvals of the draft decision;
- final check of the documents to be (partially) released,
administrative treatment and dispatch of the reply.
The completion of these steps regarding a significant number of documents,
which in the case of your request we have estimated, at this stage, to be
around 70 separate document files (including harmonised European
standards, international standards and their amendments and corrigenda)
and broad scope, cannot be expected to be carried out within the normal
time limits set out in Article 8 of Regulation 1049/2001.
As stated by the EU Courts, the European Commission needs to respect the
principle of proportionality and ensure that the interest of the applicant
for access is balanced against the workload resulting from the processing
of the application for access in order to safeguard the interest of good
administration.
Taking into account the above, please rest assured that the competent
services of the European Commission are making their best efforts to
address your request at the shortest delay possible. We will duly inform
you on the outcome of the procedure.
We apologise for the inconvenience. Many thanks for your understanding.
Best regards
SANTE D3 Medical Devices
European Commission
Directorate-General for Health and Food Safety (DG SANTE)
Unit D.3 - Medical devices
1049 Brussels, Belgium
[1][email address]
Health and Food Safety:
[2]https://ec.europa.eu/info/departments/he...
EU Public Health - Medical Devices - Sector:
[3]https://ec.europa.eu/health/md_sector/ov...
References
Visible links
1. mailto:[email address]
2. https://ec.europa.eu/info/departments/he...
3. https://ec.europa.eu/health/md_sector/ov...
Dear [email address]/ SANTE D3 Medical Devices,
Thank you for your detailed and informative response regarding my request for access to documents related to harmonised standards published in the OJEU in support of Regulation (EU) 2017/745 on medical devices.
I appreciate the transparency and thorough explanation of the steps involved in processing my request. Understanding the complexity and the extensive work required to handle approximately 70 separate document files provides valuable insight into the process and the necessary time commitment.
I am grateful for the efforts of the competent services of the European Commission to address my request promptly and efficiently. I fully understand the need to balance the interest of access with the principles of proportionality and good administration.
Thank you for keeping me informed about the progress and for your commitment to providing a comprehensive response at the earliest opportunity. I look forward to receiving the outcome of the procedure.
Best regards,
Alexander Schmalenberger
Dear Mr Schmalenberger,
Please find attached a message concerning your request for access to
Commission documents registered under the above case number 2024/1288.
Please acknowledge the receipt of this message by return email.
Kind regards,
Flora Giorgio
DG SANTE Unit D.3
Dear Secretariat General of the European Commission,
Dear Ms. Giorgio,
thank you for the message and your work.
Yours faithfully,
Alexander Schmalenberger
Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...