Date: Friday, 22 September 2023

Remote inspection arrangements

Webex video call organised by the European Ombudsman, 14:00 - 16:00

Present

European Commission

Head of Unit, SANTE.D3 (Medical Devices)

Deputy Head of Unit, SANTE.D3

Legal Officer, SANTE.D3

Policy Officer, SANTE.D3

Legal and Policy Officer, SANTE.D3

Co-ordinator for Inter-Institutional Relations, Relations with the European Ombudsman, SG.C2

European Ombudsman

Ms Amandine le Bellec, Inquiries Officer

Mr Koen Roovers, Inquiries Officer

Ms Jennifer King, Legal Expert

Mr Krzesimir Wawrzyczek-Seifert, Inquiries Trainee

Purpose of the meeting

The purpose of the meeting was for the Ombudsman inquiry team to meet with the

relevant representatives of the Commission to clarify certain matters that arose when

analysing the Commission’s reply and the complainant’s comments to that reply.

The meeting also allowed the Ombudsman inquiry team to obtain clarifications as regards the documents that the Commission had identified as falling within the scope of the Ombudsman’s inspection request, and had shared with the Ombudsman on 1 August 2023.

Introduction and procedural information

The Ombudsman inquiry team introduced themselves, thanked the European Commission representatives for meeting with them and set out the purpose of the meeting. They outlined the legal framework that applies to meetings held by the Ombudsman, in particular, that the Ombudsman would not disclose any information identified by the Commission as confidential, neither to the complainant nor to any other person outside the Ombudsman’s Office, without the Commission’s prior consent.^[1]

The inquiry team mentioned that they would prepare a draft report on the meeting to be sent to the Commission to ensure that the contents were factually accurate and complete. The meeting report would then be finalised, included in the file and provided to the complainant. No confidential information would be included in the report or otherwise provided to the complainant or any third party.

Information exchanged

Prior to the meeting, the Ombudsman inquiry team inspected the file, which included all documents that were circulated to members and observers of the MDCG prior to the  group’s last three meetings, namely those organised on 6-7 February 2023, 17-18 April 2023 and 6-7 June 2023. The Commission indicated that the documents provided are confidential.

The MDCG rules of procedure[2], which are established in accordance with the EU Regulation on medical devices[3] and the Commission’s horizontal rules on expert groups, set out by Commission Decision C(20262016)3301, include that:

“3. In accordance with Article 26 of Commission Decision C(2016) 3301, the secretariat shall make available all relevant documents, including the agendas, the minutes and the participants’ submissions, either on the Register of expert groups or via a link from the Register to a dedicated website where this information can be found. Access to dedicated  websites shall not be submitted to user registration or any other restriction. In particular, the secretariat  shall publish  the agenda and other relevant background documents in due time ahead of the meeting, followed by timely publication of minutes. Exceptions to publication shall only be foreseen where it is deemed that disclosure of a document would undermine the protection of any public or private interest as defined in Article 4 of Regulation (EC) N° 1049/2001.”

In its reply of 15 March, the Commission described two categories of documents, which
currently are not proactively made public:

(1) preliminary/draft versions of documents prior to their endorsement by the MDCG, and

(2) meeting documents that are not intended to be endorsed by the MDCG.

The Commission acknowledged that the second category of documents should also be made available on the Register in accordance with the above provision and that such documents will be made proactively available in the future, provided that the publication of those documents would not undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) 1049/2001.

Based on a review of the file and reply of the Commission, the Ombudsman shared four questions with the Commission as discussion points prior to the meeting.

1a. How does the Commission interpret “all relevant documents of expert groups and subgroups, including the agendas, minutes and the participants’ submissions” in Article 15(3) of the MDCG rules of procedure, as well as “the agenda and other relevant background documents”, which should be published “in due time ahead of the meeting”?

The Commission representatives confirmed that what it considers to be ‘all relevant documents’, are the agendas and minutes of the meetings (the former is made publicly available before the meeting and the latter after the meeting).

Participant’s submissions are slides used for presentations during the meeting, including from the Commission and different members and organisations, as well as any other submission before or during the meeting. (The MDCG’s membership includes representatives of Member State authorities (so-called type D members), representatives of third country public authorities (type E members) and organisations[4] (Type C members)[5].[6])

Background documents include:

• documents to prepare discussions that will take place during the meetings such as cover notes on individual agenda points and letters prepared by MDCG members on individual agenda points;
• documents to be endorsed by the MDCG, such as draft guidance documents, draft position papers, draft MDCG recommendation on the designation of the conformity assessment body under the MDR or the IVDR;
• documents on which the MDCG or Member State experts need to be consulted, such as draft Commission delegated acts prepared in accordance with Regulation (EU) 2017/745 on medical devices[7] (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices[8] (IVDR), for which the interinstitutional Agreement on better law-making requires the consultation of Member State experts; and
• documents to prepare certain Commission implementing acts, for which the MDR or the IVDR require prior consultation of the MDCG.
  
  

1b. Does the Commission consider that preliminary/draft versions of documents prior to their endorsement by the MDCG are covered by “other relevant background documents”?

The Commission representatives said that yes, preliminary/draft versions of documents prior to their endorsement by the MDCG are covered in this category.

2a. Does the Commission conduct individual assessments of draft documents that are intended for MDCG endorsement, to be able to reach the conclusion that these documents cannot be disclosed?

The Commission representatives stated that they do conduct individual assessments on a case-by-case basis of documents, including draft documents, to see whether they can be made public.

They made reference to two sets of provisions, which apply when assessing whether or not pro-actively making public draft documents prior to MDCG endorsement. Those provisions are set out in:

• Point 11 of the rules of procedures of the MDCG which lays down transparency rules and establishes 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 Article 4 of Regulation (EC) No 1049/2001

The Commission representatives considered that assessing whether the proactive publication of draft/preliminary versions of documents would undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) 1049/2001 was relevant for the purpose of the publication. In addition, the Commission stated that it does not apply a general presumption of non-disclosure in relation to draft documents that have not yet been endorsed by the MDCG.

• ·Articles 109 MDR and 102 IVDR establish confidentiality obligations which shall apply also to the exchange of information between national competent authorities (NCAs) and the Commission. To make a document public prior to MDCG endorsement, the Commission would need prior agreement of the NCAs. Those provisions need to be taken into account when assessing whether exceptions to the publication would apply.

The Commission representatives pointed out that documents requiring MDCG endorsement are drafted through a collective effort of and/or with contribution by Competent Authorities of Member States. Those documents aim to ensure the effective and harmonised implementation of the MDR and IVDR. By contributing to the development of those documents openly, in a context of mutual trust, representatives of Competent Authorities of Member States express and exchange views regarding different possible approaches. Their views may change or evolve over time following the exchange of arguments with representatives of other Competent Authorities and the Commission until the document is finally endorsed by the MDCG. Draft/preliminary versions of documents prior to the endorsement by the MDCG, therefore, contain the – not yet final – views or opinions of Competent Authorities of Member States. Those views or opinions should be regarded as confidential information and data in documents that aim to ensure the effective and harmonised implementation of the Regulations. Under Article 109(1) MDR and Article 102(1) IVDR, this information is protected and, in principle, these draft/preliminary versions of documents prior to their endorsement by the MDCG cannot be made public.

When asked by the Ombudsman inquiry team to provide an example of how these documents contribute to the implementation of the Regulations and the detrimental effect of publishing draft documents prior to their endorsement on the sector, the Commission representatives referred for instance to the revision of the MDCG guidance document on significant changes[9].  Commission representatives noted that what is considered to be a significant change by Competent Authorities has evolved over time in light of the exchange of views of Competent Authorities regarding different possible approaches. Making draft versions of the guidance document containing evolving views of Competent Authorities on this subject public, could be the cause of confusion in the sector with major impact for manufacturers of legacy devices and be detrimental to the effective implementation of the MDR and IVDR in this regard.

Further, the Commission representatives noted the risk of disclosing draft documents that have not yet been endorsed by the MDCG as this would make apparent the not yet final views among EU Member States that could be taken advantage of by stakeholders, thus undermining the effective and harmonised implementation of the Regulations. A concrete example of this risk that the Commission representatives mentioned relates to a proposal to reclassify certain medical devices[10]. Should drafts of the document for reclassification have been made public prior to its adoption, showing potential divergent views among national competent authorities about the reclassification, those authorities could have been exposed to the pressure of stakeholders with an aim to change the draft in favour of their products[11]. The Commission Better Regulation requirements that apply to implementing acts foresee dedicated fora for ensuring that consultations of stakeholders are conducted while preparing implementing acts and results are taken into account in the decision-making process.

Moreover, the Commission representatives also mentioned that in the context of the MDCG and its task to contribute to the development of guidance and other documents aimed at ensuring the effective and harmonised implementation of the Regulations, the contributions and views expressed by Competent Authorities relevant for the drafting of documents are here also protected. In accordance with Article 109(2) MDR and Article 102(2) IVDR, the Commission cannot make public any draft/preliminary version of documents without the prior agreement of all Competent Authorities that are contributing to drafting a particular document.

Finally, the Commission representatives said that, to their understanding, confidentiality provisions included in the MDR and IVDR take precedence over the Commission’s horizontal rules for expert groups and other similar entities, as these are provisions included in the legislative act setting up the MDCG. In this respect, the Commission highlighted that the MDCG is not an expert group established by the Commission on its own initiative, but an ‘other similar entity’, as it is set up by the Union legislator[12].

The Ombudsman inquiry team noted that the Commission’s written reply of 15 March 2023 to the Ombudsman, which had been shared with the complainant for comments, did not include the above arguments. The Commission representatives acknowledged that the interplay between the Commission’s horizontal rules for expert groups and other similar entities and the specific confidentiality provisions set out in the MDR and IVDR caught their specific attention in recent exchanges with representatives of EU Member States.

The EO inquiry team referred to recent case law in which the EU Courts have rejected similar arguments concerning the need to protect the decision making process, where the documents requested involve the positions of Member States.[13] The Commission representatives pointed out that in the specific situation of the MDCG, the legislative act setting up this ‘other similar entity’ contains specific legislative provisions around confidentiality, whereby all parties involved in the application of the MDR and IVDR must respect the confidentiality of information and data in order to notably protect the effective implementation of the Regulations.

2b. How are the individual assessments in the context of pro-active disclosure of draft MDCG documents conducted?

The Commission representatives said that preparatory meetings involving the whole unit are organised in advance of each MDCG meeting to notably discuss the draft documents that will be submitted to the MDCG for endorsement and whether they can be proactively made public. They stated that the MDCG meeting agendas and documents to prepare discussions during the meeting are made public before the meeting, if they do not undermine the protection of a public or private interest as defined in Article 4 of Regulation (EC) 1049/2001 taking into account the confidentiality requirements provided for in Article 109 MDR and Article 102 IVDR.

The decision on disclosure is implemented through publication in the Commission’s register of expert groups. Presentations that are made during MDCG meetings are normally made public afterwards. Personal data and commercially confidential information are redacted from the documents that are made public. If the publication of a presentation would run counter to the confidentiality requirements provided for in Article 109 of the MDR and Article 102 of the IVDR, the Commission will not make the presentation public.

3. In this context, have Member State experts objected to disclosing draft MDCG documents that are intended for MDCG endorsement?

The Commission representatives said that they had not received any objections to publication/disclosure of draft MDCG documents prior to their endorsement by Member State experts. However, they added in reply to a question from the Ombudsman inquiry team that they had never explicitly sought the consent of those national authorities, as the confidentiality provisions in the MDR and IVDR (Articles 109 and 102 respectively) specifically require the prior agreement of the originating authorities and not their specific objection. In the case of draft/preliminary versions of documents prior to their MDCG endorsement, these contain the – not yet final – views and opinions of Competent Authorities of Member States, which should be regarded as confidential information and data exchanged between Competent Authorities and the Commission. The Commission can therefore not make public any draft/preliminary version of documents without the prior agreement of all Competent Authorities that are contributing to drafting a particular document. 

4. What is the timeline of the ongoing review of the Commission’s proactive publication practice in relation to the MDCG?

From 17 November 2022, the Commission started making public all of the participants’ submissions, where their publication does not undermine the protection of a public or private interest as defined in Regulation (EC) 1049/2001 taking into account confidentiality requirements provided for in Article 109 MDR and Article 102 of IVDR.

Due to the limited resources available in coordinating the 30 to 40 MDCG related meetings per year, as of September 2023 the Commission has outsourced some administrative support tasks related to the MDCG. The Commission representatives said that the assessment as regards the confidentiality of documents or the application of the exceptions under Article 4 Regulation 1049/2001 is not being outsourced.

Currently, MDCG agendas are made public one or two weeks before the MDCG meeting. The Commission aims to make public the meeting minutes and participants’ submissions as soon as possible after the meeting. However, the Commission representatives acknowledged that delays have occurred in this respect, with publication of the minutes only happening two or three months after the MDCG meetings. The Commission representatives said that assessing participants’ submissions takes less time than the MDCG minutes, because the minutes necessitate consultation with the meeting participants on the content of these minutes.

Follow-up

The Commission representatives agreed to provide a written reply to the first two discussion points, as the answers it had shared with the Ombudsman’s inquiry team during the meeting had evolved since the Commission had submitted its reply on 15 March 2023. As such, neither the Ombudsman, nor the complainant, was aware of this argumentation provided by the Commission, before the inspection meeting. The Commission’s subsequent written reply is included in the annex to this inspection report.

The inquiry team thanked the European Commission representatives for their time and for the explanations provided.

 

Brussels, 28 September 2023

Ms Jennifer King                                                                                                             Mr Koen Roovers

Legal Expert                                                                                                                     Inquiries Officer

 

Annex - Written reply of the Commission on questions 1 and 2

1. How does the Commission interpret “all relevant documents of expert groups and subgroups, including the agendas, minutes and the participants’ submissions” in Article 15(3) of the MDCG rules of procedure, as well as “the agenda and other relevant background documents”, which should be published “in due time ahead of the meeting”? Does the Commission consider that preliminary/draft versions of documents prior to their endorsement by the MDCG are covered by “other relevant background documents”? If not, why not?

The Commission considers as relevant documents of the MDCG the following documents, grouped in categories:

1. Agendas and minutes of meetings;

2. Participants’ submissions: PowerPoint presentations made during MDCG meetings (by MDCG members and stakeholders), any other document submitted by participants for/during MDCG meetings;

3. Background documents:

a. documents to prepare discussions/that will be discussed during MDCG meetings: cover notes on individual agenda points prepared by the Commission services, letters prepared by MDCG members on individual agenda points.

b. documents to be endorsed by the MDCG, e.g., draft guidance documents, draft position papers, draft MDCG guidance documents, draft MDCG position papers, draft MDCG recommendation on the designation of the conformity assessment body under the MDR or the IVDR.

documents on which the MDCG or Member State experts need to be consulted,

e.g., draft Commission delegated acts prepared in accordance with the MDR or IVDR, for which the Interinstitutional Agreement on Better Law-Making requires the consultation of Member State experts; documents to prepare certain Commission implementing acts, for which the MDR or the IVDR require prior consultation of the MDCG, e.g. Art 51(3) MDR.

Therefore, the Commission does consider draft versions of documents prior to their endorsement by the MDCG to be covered by the wording of “other relevant background documents”.

2. If the Commission considers that preliminary/draft versions of documents prior to their endorsement by the MDCG are covered by “other relevant background documents”, how does the Commission assess whether disclosure of such documents could undermine the protection of the ongoing decision-making process?

The Commission said in its reply of 15 March 2023 that the work carried out by expert groups is a collective one, which very often leads to conclusions being reached by consensus, in a spirit of mutual trust, and that experts should be able to contribute freely to the work of expert groups and to express their views in a flexible way, in light of the specific circumstances: “This interest would be significantly compromised should all versions of preliminary drafts be made accessible to the public by default and without ad hoc assessment and this would ultimately be detrimental to the decision-making process of this expert group.”

Does this imply that the Commission conduct s individual assessments of draft documents that are intended for MDCG endorsement, to be able to reach the conclusion that these documents cannot be disclosed? If so, how are such individual assessments conducted?

Pursuant to Article 26(2) of the horizontal rules on expert groups, before proactively publishing  any document on the European Commission Register for Expert Groups and Other Similar Entities or any other website, the Commission assesses whether its publication would undermine  a public or private interest as defined in Article 4 of Regulation (EC) No 1049/2001, as also provided for by Article 15(3) of the MDCG rules of procedure. For the purposes of this assessment, the Commission further takes into consideration sectorial legislation, which provides for specific obligations to respect the confidentiality of information and data in accordance with Article 109(1) of Regulation (EU) 2017/745 and Article 102(1) of Regulation (EU) 2017/746, as well as special rules in relation with information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission in accordance with Article 109(2) of Regulation (EU) 2017/745 and Article 102(2) of Regulation (EU) 2017/746.

In practice, this means that for documents related to the work of the MDCG, the Commission assesses whether the proactive publication of a document would run counter to any of the exceptions listed in Article 4 of Regulation (EC) No 1049/2001 taking into account the confidentiality requirements provided for in Article 109 of Regulation (EU) 2017/745 or Article 102 of Regulation (EU) 2017/746.

As explained in the Commission’s reply to the Ombudsman, documents such as MDCG guidance documents, MDCG position papers, MDCG recommendations for designation of notified bodies, which are still at a draft stage, are not proactively published. The reason being that such a publication would seriously undermine the ongoing decision-making process within the MDCG, which is one of the interests protected pursuant to Article 4 of Regulation (EC) No 1049/2001. Documents requiring MDCG endorsement are drafted through a collective effort of and/or with contributions by Competent Authorities of Member States. Those documents aim to ensure the effective and harmonised implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (see Article 105 and Article 99 respectively). By contributing to the development of those documents openly, in a context of mutual trust, representatives of Competent Authorities of Member States express and exchange views regarding different possible approaches. Their views may change or evolve over time following the exchange of arguments with representatives of other Competent Authorities and the Commission until the document is finally endorsed by the MDCG. Draft/preliminary versions of documents prior to the endorsement by the MDCG contain the – not yet final – views or opinions of Competent Authorities of Member States. Those views or opinions should be regarded as information and data whose confidentiality must be preserved in order to protect the effective and harmonised implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 in line with Article 109(1) and Article 102(1) respectively thereof,.

Furthermore, in accordance with Article 109(2) of Regulation (EU) 2017/745 and Article 102(2) of Regulation (EU) 2017/746, any information that is exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authorities.

In the context of the MDCG and its task to contribute to the development of guidance and other documents aiming to ensure the effective and harmonised implementation of the Regulations (Article 105 of Regulation (EU) 2017/745 and Article 99 of Regulation (EU) 2017/746), the contributions and views expressed by Competent Authorities relevant for the drafting of documents are here also protected. In accordance with Article 109(2) of Regulation (EU) 2017/745 and Article 102(2) of Regulation (EU) 2017/746, the Commission cannot make public any draft/preliminary version of documents without the prior agreement of all Competent Authorities that are contributing to drafting a particular document.

Once a draft document has received the required MDCG endorsement, in principle, the information and data from Competent Authorities of Member States contained in the draft document can no longer be perceived as being of a confidential nature. The documents are then published on the website of the European Commission.

The Commission is legally bound to the confidentiality obligations laid down in Article 109 of Regulation (EU) 2017/745 and Article 102 of Regulation (EU) 2017/746 and interprets the Rules of Procedures of the MDCG and the horizontal rules on expert groups in light of these confidentiality obligations stemming from the said legislation.

Therefore, the Commission makes documents directly accessible to the public on the Commission website without prejudice to the exceptions laid down in Article 4 of Regulation (EC) No 1049/2001 taking into account the confidentiality obligations established in Article 109 of Regulation (EU) 2017/745 and Article 102 of Regulation (EU) 2017/746.

 

[1] Article 4.8 of the European Ombudsman’s Implementing Provisions.

[2] See Point 15(3) on page 6: https://health.ec.europa.eu/system/files/2022-01/md_dialogue_mdcg_rules_procedure_en.pdf.

[3] in accordance with Article 103(8) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, see: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745.

[4] Organisations were selected after an open call for a 5 year term.

[5] Expert groups may be composed of the following types of members:

(a) individuals appointed in their personal capacity who are to act independently and in the public interest (‘Type A members’);

(b) individuals appointed to represent a common interest shared by stakeholders in a particular policy area, who do not represent an individual stakeholder, but a policy orientation common to different stakeholder organisations (‘Type B

members’). Where appropriate, those individuals may be appointed on the basis of proposals put forward by the stakeholders concerned;

(c) organisations in the broad sense of the word, including companies, associations, Non-Governmental Organisations, trade unions, universities, research institutes, law firms and consultancies (‘Type C members’);

(d) Member States' authorities, at national, regional or local level (‘Type D members’);

(e) other public entities, such as third countries' authorities, including candidate countries’ authorities, Union bodies, offices or agencies and international organisations (‘Type E members’).
See Article 7(2) of the Commission’s horizontal rules for expert groups, which are available here: https://ec.europa.eu/transparency/documents-register/api/files/C(2016)3301_0/de00000001029661?rendition=false.

[6] See: https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565. The MDCG has 13 subgroups of which two include no observers given the subjects matter discussed in these subgroups, namely the: (i) Market Surveillance subgroup and (ii) Notified Bodies Oversight (NBO) subgroup.

[7] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

[8] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

[9] MDCG 2020-3 rev.1: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en

[10] See for more info: https://eur-lex.europa.eu/eli/reg_impl/2022/2347/oj

[11] See for more info: https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/manufacturers-devices-without-intended-medical-purpose_en.

[12] See Article 2 of Decision C(2016)3301.

[13] See Pech v. Council (case T-252/19): https://curia.europa.eu/juris/document/document.jsf;jsessionid=AEE8CA77E9255AE6735D10447B41F178?text=&docid=240171&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=1941688. Similar arguments were put forward in De Capitani v Parliament (T-540/15) and Pollinis v. Commission (T‑371/20 and T‑554/20).