Decision on the decision of the European Commission to revise the risk classification of devices involving brain stimulation under rules governing products without an intended medical purpose in the context of the EU Medical Devices Regulation (case 157/2023/VB)
DECISION
CASE 157/2023/VB - OPENED ON Wednesday | 15 March 2023 - DECISION ON Thursday | 25 April 2024 - INSTITUTION CONCERNED European Commission ( Solution achieved ) - COUNTRY Denmark
The case concerned how the European Commission prepared an implementing regulation to revise the risk classification of certain devices involving brain stimulation in the context of the EU Medical Devices Regulation. The Commission drew up and adopted the implementing regulation in response to a request by six Member States, and based the decision on evidence from a list of sources provided by those Member States.
The complainant, a neuroscience company, took issue with the evidence and sources used by the Commission, as well as with how the Commission consulted stakeholders on the draft implementing regulation.
The Ombudsman found that the Commission had not verified whether the scientific sources provided by the Member States were sufficiently representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. In this sense, the Ombudsman considered that the Commission’s assessment of the sources was not sufficient for it to be in a position to decide whether, within the meaning of the Medical Devices Regulation, ‘new scientific evidence’ would justify the reclassification of the products.
To address this, the Ombudsman proposed that the Commission verify whether the sources provided by the Member States are comprehensive and representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. Should the Commission conclude that the most recent scientific evidence does not support the reclassification, it should take action to remedy the situation.
The Commission accepted the Ombudsman’s solution proposal and agreed to mandate the Scientific Committee on Health, Environmental and Emerging Risks to issue a scientific opinion on the risk posed by the use of brain stimulation devices for non-medical purpose. Based on this scientific opinion, the Commission will assess the need to take further action.
The Ombudsman welcomed the Commission’s positive response to her solution proposal and closed the case.
Background to the complaint
1. The Medical Devices Regulation[1] (MDR) applies to medical devices for human use, as well as a range of devices and products without an intended medical purpose. The MDR sets out rules for the classification of devices falling under its scope on the basis of their intended purpose and inherent risk. These products and devices are classified in annexes to the MDR. Depending on how these devices are classified, they will be subject to different requirements regarding conformity and risk assessment in order to receive a CE mark[2] enabling sale and use within the EU. The conformity assessment is carried out by ‘notified bodies’ within the EU Member States.
2. Where there is new evidence concerning devices falling within the scope of the MDR, or new information emerges in the context of market surveillance, they may be reclassified through the adoption of an implementing act. The Commission is responsible for adopting such implementing acts, which can be drafted either on the request of Member States[3] or on the Commission’s own initiative.[4] These implementing acts are adopted through a comitology procedure[5], with the Commission consulting the relevant subgroup of the Medical Device Coordination Group (MDCG)[6] and the MDCG itself, before submitting a draft implementing regulation or act to the Committee on Medical Devices[7]. The Committee issues its opinion on the draft before it is adopted by the Commission.
3. On 1 December 2022, in response to the request of six Member States, the Commission adopted an implementing regulation reclassifying certain groups of products without an intended medical purpose (’the implementing regulation’).[8] Among other products, the implementing regulation reclassified equipment intended for brain stimulation (hereinafter ’brain stimulation devices’). According to the MDR, brain stimulation devices “apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain”.[9] Brain stimulation devices without an intended medical purpose claim to improve the user’s wellness and cognitive functions and can be used without medical supervision.
4. The implementing regulation reclassified brain stimulation devices without an intended medical purpose as class III, the highest risk class.[10] This means that these products have to comply with more demanding requirements in the context of the conformity assessment by notified bodies.
5. The complainant, a neuroscience company producing brain stimulation devices, asked the Commission to put on hold the implementation of the implementing regulation and to open a new consultation period to collect stakeholders’ input. It also requested the Commission to grant public access to the Member States’ request for reclassification and to the scientific evidence on which the decision to reclassify brain stimulation devices was based.
6. The Commission provided the requested documents and explained that the implementing regulation could not be put on hold since it had already been published on the Official Journal. It said that it had developed the implementing regulation with the support of the Member States’ experts participating in the ’Annex XVI products subgroup’[11] of the MDCG. The MDCG was also consulted on the final draft of the implementing regulation, which was published for feedback from 11 August 2022 to 8 September 2022 on the Commission’s ‘Have your say’ portal.[12] The Committee on Medical Devices, the comitology committee, then issued a positive opinion on the draft implementing regulation.
7. On 21 January 2023, the complainant submitted a complaint to the Ombudsman arguing that the implementing regulation was adopted without taking into account the most recent scientific evidence and without proper consultation of stakeholders. The Ombudsman received several other complaints on the same issue from other stakeholders in the area.
The Ombudsman's proposal for a solution
8. The Ombudsman opened an inquiry into the procedure that led to the adoption of the implementing regulation. In particular, the Ombudsman inquired into whether the Commission followed the relevant rules set out in the MDR and the Commission’s Better Regulation guidelines and principles.[13] The inquiry did not concern the decision to reclassify brain stimulation devices as class III as such nor the assessment regarding the classification of devices under the MDR.
9. In the course of the inquiry, the Ombudsman inquiry team met with representatives of the Commission and received the comments of the complainant on the report of the meeting.[14]
10. The Ombudsman found that the Commission had not verified whether the scientific sources provided by the Member States were sufficiently representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. In this sense, the Ombudsman considered that the Commission’s assessment of the sources was not sufficient for it to be in a position to decide whether, within the meaning of the Medical Devices Regulation, ‘new scientific evidence’ would justify the reclassification of the products.
11. The Ombudsman also noted that the feedback received by the Commission on the draft implementing regulation was very limited. The Commission had published it for feedback for four weeks during the summer holidays, which is an unfavourable period for receiving extensive feedback from stakeholders. In addition, the Commission did not publish, together with the draft implementing regulation, the list of evidence provided by the Member States, which could have allowed stakeholders to provide feedback to the Commission on the adequacy of such evidence.
12. In light of this, the Ombudsman proposed[15] to the Commission that it should
verify whether the evidence provided by the Member States is comprehensive and representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. Should the Commission conclude that the most recent scientific evidence does not support the reclassification, it should take action to remedy the situation, for instance by adopting a new implementing act, on its own initiative, based on Article 51(4) of the MDR. In doing so, the Commission should also take into account the Ombudsman’s observations regarding the collection of feedback on draft implementing acts.
13. The Commission accepted the Ombudsman’s proposal for a solution,[16] by agreeing to mandate the Scientific Committee on Health, Environmental and Emerging Risks to issue a scientific opinion on the risk posed by the use of brain stimulation devices for non-medical purpose. Based on this scientific opinion, the Commission will assess the need to take further action.
14. As regards the Ombudsman’s observations on the collection of feedback on draft implementing acts, the Commission informed the Ombudsman that it will consider extending the consultation period of public consultations launched during the summer period where the draft measure is not urgent. It will also ensure, where necessary, the inclusion of as much information as possible on the scientific evidence supporting a draft measure when consulting on it. The Commission further committed to assessing whether the participation of stakeholders in meetings of the MDCG and its subgroups should be expanded and whether new stakeholders, in particular organisations specialised on brain stimulation, should be included in the Annex XVI subgroup.
15. The Ombudsman sent the Commission’s reply to the complainant for comments. The complainant expressed its satisfaction with the Commission’s reply.
The Ombudsman's assessment after the proposal for a solution
16. The Ombudsman welcomes the Commission’s positive response to her solution proposal. Since the Commission accepted the Ombudsman’s proposal, the Ombudsman closes the case.
Conclusion
Based on the inquiry, the Ombudsman closes this case with the following conclusion:
The Commission has accepted the Ombudsman’s proposal for a solution.
The complainant and the Commission will be informed of this decision.
Emily O'Reilly
European Ombudsman
Strasbourg, 25/04/2024
[1] Regulation (EU) 2017/745 of 5 April 2017 on medical devices, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745.
[2] The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. https://single-market-economy.ec.europa.eu/single-market/ce-marking_en
[3] Article 51(3) of the MDR reads as follows:
“At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following:
[...]
(b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII”.
[4] Article 51(4) of the MDR reads as follows:
“The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3”.
[5] More information on the comitology process: https://commission.europa.eu/law/law-making-process/adopting-eu-law/implementing-and-delegated-acts/comitology_en.
[6] The MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. It is divided into 13 subgroups, which provide advice and guidance in their fields of expertise. Members of the subgroups are appointed by the Member States. Stakeholders participate in meetings of the subgroups following applications to the dedicated calls for expression of interest. Additional information is available at https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&do=groupDetail.groupDetail&groupID=3565.
[7] The Committee on Medical Devices is a comitology committee, which includes experts from relevant national authorities in the EU Member States: https://ec.europa.eu/transparency/comitology-register/screen/committees/C49800/consult?lang=en.
[8] Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose, https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32022R2347&qid=1691136126487.
[9] Section 6 of Annex XVI to the MDR.
[10] Commission Implementing Regulation (EU) 2022/2347, Article 1
[11] The ’Annex XVI products subgroup’ develops common specifications for products without an intended medical purpose listed in Annex XVI to the MDR. Additional information can be found in the terms of reference of the subgroup available at https://health.ec.europa.eu/system/files/2020-06/md_tor-wg13-annex_xvi_0.pdf.
[12] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
[13] https://commission.europa.eu/law/law-making-process/planning-and-proposing-law/better-regulation/better-regulation-guidelines-and-toolbox_en.
[14] https://www.ombudsman.europa.eu/en/doc/inspection-report/en/170462.
[15] https://www.ombudsman.europa.eu/solution/184981.
[16] https://www.ombudsman.europa.eu/doc/correspondence/184982.
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