Background to the complaint

1. The Medical Device Coordination Group (MDCG)^[1] is composed of experts appointed by Member States (members) and stakeholders (observers). It provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of the EU legislation on medical devices, that is, the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation.[2] The Commission chairs the MDCG, and provides technical, scientific and logistic support.

2. In September and October of 2022, the complainant and the Commission exchanged about whether the Commission’s practice regarding the proactive publication of documents concerning the work of the MDCG is in line with the Commission’s general rules applicable to expert groups[3] (referred to by the Commission as ‘horizontal rules’).

3. In particular, the complainant asked whether the Commission could make public draft documents that are intended for MDCG ‘endorsement’. The Commission replied that it publishes neither draft versions of documents discussed in meetings, which will potentially be subject to MDCG endorsement, nor positions of members or observers of the MDCG that feed into such documents. The Commission added that the disclosure of such draft documents could negatively affect ongoing decision-making processes.

4. The Commission noted, however, that it was reviewing its MDCG transparency practice, and that any changes to that practice would require approval by the MDCG itself.

5. Dissatisfied with the outcome of his exchanges with the Commission, the complainant turned to the Ombudsman on 28 November 2022.

The inquiry

6. The Ombudsman opened an inquiry to assess how the Commission ensures the transparency of the documents relating to the work of the MDCG[4].

7. In the course of the inquiry, the Ombudsman received the reply[5] of the Commission and the complainant’s subsequent comments[6] on this reply. The Ombudsman inquiry team also inspected the Commission’s file on three MDCG meetings that took place in the first half of 2023 and held a meeting with the representatives of the Commission to discuss certain matters that arose during the inspection of those documents. The inspection meeting report[7] was subsequently shared with the complainant who submitted comments[8] on it.

Arguments presented to the Ombudsman

By the complainant

8. The complainant took issue with what he perceived as a blanket exception to the publication of draft documents that are intended for endorsement by the MDCG. While the complainant did not dispute the possibility that, in certain circumstances, premature disclosure of a document that is intended for MDCG endorsement could undermine ongoing decision-making processes, he argued that any exception to proactive publication should be justified based on an individual assessment.

9. In support of his view, the complainant cited EU case-law on public access to documents, which has established that exceptions to public access must be interpreted and applied strictly.[9]

10. The complainant acknowledged that the documents at issue are not legislative documents (to which greater transparency standards apply). However, he contended that the same principles apply. He argued that those with an interest in these documents would understand that the topics under discussion are complicated and drafts may change. However, public debate on drafts can inform the debate and improve the quality of the documents.

11. The complainant argued that greater transparency of the documents that are intended for MDCG endorsement would strengthen public trust in the decision-making process.

By the Commission

12. In its reply to the Ombudsman, the Commission emphasised that the involvement of stakeholders and the requirement of proactive transparency are vital elements of the MDCG’s governance and working methods. The Commission said that it regularly makes public, on the expert group register,^[10] the agendas ahead of the plenary and subgroup meetings and minutes on such meetings, after participants have been consulted on them. The Commission also makes public documents that have been endorsed by the MDCG on the Commission’s dedicated website^[11].

13. The Commission acknowledged that some meeting documents that are not intended for MDCG endorsement were not made public proactively, even though this should have been done, in line with the applicable rules.[12] This includes presentations, background information and other working documents on individual agenda points prepared by the Commission, MDCG members or observers. The Commission committed to making such documents proactively available, if necessary in a redacted format, unless their disclosure would undermine the protection of any public or private interest under the EU legislation on public access to documents[13].

14. The Commission noted that the MDCG is also consulted on draft delegated acts developed in accordance with the EU legislation that established the MDCG.^[14] Unless justified on grounds of urgency, draft delegated acts are usually subject to a four-week public consultation period^[15] and are therefore in the public domain before they are formally submitted to the MDCG. Once adopted by the Commission, they are made public on the delegated acts register.^[16]

15. Drafts of MDCG guidance documents, MDCG position papers, and MDCG recommendations for designation of notified bodies that have not yet been endorsed by the MDCG, are not made public proactively. The Commission argued that, if disclosed prematurely, these documents could create confusion, prolong decision-making processes or otherwise undermine the decision-making process relating to the outputs of the MDCG.

16. In the meeting with the Ombudsman inquiry team, the Commission representatives further said that the EU legislation setting up the MDCG contains specific provisions around confidentiality, whereby all parties involved in the application of that legislation must respect the confidentiality of information and data in order to protect the legislation’s effective implementation.^[17] In particular, the Commission representatives explained that the contributions and views expressed by representatives of the Member States on draft documents must not be disclosed without their prior agreement.^[18]

The Ombudsman's assessment

17. Ensuring a high level of transparency in relation to the work of expert groups and similar bodies is vital given the important work they carry out in advising the Commission on legislative proposals and policy initiatives, draft delegated acts, and the implementation of existing legislation, programmes and policies. Facilitating public scrutiny can help bolster trust in the system.

18. The Ombudsman has previously assessed the transparency of expert groups, among other matters.^[19] At the time, the Commission committed to making numerous improvements, including the adoption of rules^[20] governing the transparency of expert groups.

19. The MDCG should act in accordance with the EU legislation on medical devices^[21], the Commission’s rules on expert groups,^[22] the MDCG’s terms of reference,^[23] and its own rules of procedure^[24].

20. The MDCG’s terms of reference and rules of procedure[25] require the Commission to make available all relevant documents. This includes making public the agenda and other relevant background documents in due time ahead of meetings, with minutes of meetings to be published swiftly thereafter. Documents are made public on the register of expert groups^[26] or through a link from the register to a dedicated website. Crucially, exceptions to the proactive publication of MDCG documents are foreseen only where it is deemed that disclosure of a document would undermine the protection of a public or private interest as defined in the EU legislation on public access to documents.^[27]

21. In reply to the Ombudsman, the Commission confirmed that draft documents intended for MDCG endorsement are relevant background documents under the MDCG rules of procedure. As such, they should be considered for proactive publication in due time ahead of MDCG meetings.

22. However, in the context of the inspection by the Ombudsman inquiry team, it was not clear how the Commission applies this practice of assessing draft documents prior to their endorsement by the MDCG with a view to their potential proactive publication. During the meeting with the Ombudsman inquiry team, the Commission clarified that individual assessments of draft documents that are intended for MDCG endorsement are in fact carried out during preparatory meetings in advance of MDCG meetings. In this context, the Commission noted that it cannot make public any draft version of documents without the prior agreement of all MDCG members that contribute to the drafting of the documents in question.[28]

23. The Ombudsman welcomes the Commission’s commitment to, in future, proactively publish further background documents, such as presentations, background information and other working documents on individual agenda points prepared by the Commission, MDCG members or observers, unless their disclosure would undermine the protection of a public or private interest under the EU legislation on public access to documents^[29]. She also takes note of the Commission’s clarification that it does conduct individual assessments also of such draft documents that are intended for MDCG endorsement, with a view to their potential proactive disclosure. This is in line with the MDCG’s terms of reference and rules of procedure, which explicitly state that exceptions to publication can be made only where it is deemed that disclosure of a document would undermine the protection of a public or private interest as defined in the EU legislation on public access to documents.

24. As such, the Ombudsman finds that no further inquiries are justified.

25. That said, the Ombudsman considers that the Commission could do more to ensure that it gives the greatest possible effect to the transparency provisions in the relevant rules. In particular, the Commission should consider including in the MDCG minutes a list of all relevant background documents discussed in the respective meeting. Where the Commission determines that a relevant background document cannot be made public proactively, this should be indicated in the minutes, along with the reasons justifying this. This will allow the public to know about the existence of such documents and enable interested parties to request public access, if necessary. The Ombudsman will make a suggestion to that effect.

Conclusion

Based on the inquiry, the Ombudsman closes this case with the following conclusions:

The Ombudsman considers that no further inquiries are justified.

The complainant and the Commission will be informed of this decision.

Suggestion for improvement

To further transparency and enable the public to request access if necessary, the Commission should include in the MDCG minutes a list of all relevant background documents discussed in the respective meeting. Where the Commission determines that a relevant background document cannot be made public proactively, this should be indicated in the minutes, along with any reasons justifying this.

 

Emily O'Reilly
European Ombudsman

Strasbourg, 23/04/2024

 

[1] See: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565

[2] Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 ; and Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices (IVDR): https://eur-lex.europa.eu/eli/reg/2017/746/oj .

[3] As set out in Commission Decision C(2016) 3301 of 30.5.2016 establishing horizontal rules on the creation and operation of Commission expert groups: https://ec.europa.eu/transparency/documents-register/api/files/C(2016)3301_0/de00000001029661?rendition=false.

[4] See: https://www.ombudsman.europa.eu/en/opening-summary/en/164286.

[5] See: https://www.ombudsman.europa.eu/doc/correspondence/185371.

[6] See: https://www.ombudsman.europa.eu/doc/correspondence/185372.

[7] See: https://www.ombudsman.europa.eu/doc/inspection-report/185373.

[8] See: https://www.ombudsman.europa.eu/doc/correspondence/185374.

[9] See De Capitani v. Council, T-163/21, ECLI:EU:T:2023:15, paragraphs 66 to 69 and paragraph 79, available at: https://curia.europa.eu/juris/document/document.jsf;jsessionid=2D5CF916F1AE6313EE79D4DE53291E9A?text=&docid=269684&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=23684646

[10] See: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565. 

[11] See: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en.

[12] In accordance with Article 26 of the Commission Decision C(2016)3301: https://ec.europa.eu/transparency/documents-register/detail?ref=C(2016)3301&lang=en and Point 15 of the MDCG rules of procedure, available at: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565.

[13] Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43–48, available at: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001R1049.

[14] Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR), see: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745; and Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices (IVDR): see: https://eur-lex.europa.eu/eli/reg/2017/746/oj.

[15] For more detail on such public consultations, see: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives?frontEndType=DEL_ACT.

[16] See: https://webgate.ec.europa.eu/regdel/#/delegatedActs?lang=en.

[17] Article 109 of the MDR and Article 102 of the IVDR.

[18] See Article 109 of the MDR and Article 102 of the IVDR.

[19] Case OI/6/2014/NF concerning the composition and transparency of European Commission expert groups: https://www.ombudsman.europa.eu/en/case/en/43789.

[20] Commission Decision C(2016)3301 of 30 May 2016 establishing horizontal rules on the creation and operation of Commission expert groups, available at: https://ec.europa.eu/transparency/documents-register/detail?ref=C(2016)3301&lang=en.

[21] Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR), see: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745; and Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices (IVDR): see: https://eur-lex.europa.eu/eli/reg/2017/746/oj.

[22] Commission Decision establishing horizontal rules on the creation and operation of Commission expert groups (C(20262016)3301):

https://ec.europa.eu/transparency/documents-register/api/files/C(2016)3301_0/de00000001029661?rendition=false.

[23] Available at: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565

[24] https://health.ec.europa.eu/system/files/2022-01/md_dialogue_mdcg_rules_procedure_en.pdf

[25] See Point 15(3) of the Rules of Procedure of the Medical Device Cooperation Group, available at: https://health.ec.europa.eu/system/files/2022-01/md_dialogue_mdcg_rules_procedure_en.pdf

[26] See: https://ec.europa.eu/transparency/expert-groups-register/screen/home?lang=en.

[27] See Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43–48, available here: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001R1049.

[28] Due to confidentiality provisions in the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation (Articles 109 and 102 respectively),

[29] As defined in Article 4 of Regulation (EC) No 1049/2001, see footnote 12.