Made in accordance with Article 2(10) of the Statute of the European Ombudsman[1]

Background to the complaint

1. The Medical Devices Regulation[2] (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[3] 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[4] or on the Commission’s own initiative.[5] These implementing acts are prepared under the comitology process[6], with the Commission consulting the relevant subgroup of the Medical Device Coordination Group (MDCG)[7] and the MDCG itself, before submitting a draft implementing regulation or act to the Committee on Medical Devices[8]. 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’).[9] 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”.[10] 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.[11] 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’[12] of the MDCG. Stakeholders of the subgroup were consulted (see paragraph 23 below for further details). 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 ‘Have your say’ portal.[13] The Committee on Medical Devices 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 the affected stakeholders. The Ombudsman received several other complaints on the same issue from other stakeholders in the area.

The inquiry

8. The Ombudsman opened an inquiry into the complainant’s claim that the Commission failed to take an evidence-based and participative approach in the development and adoption of the implementing regulation.

9. In the course of the inquiry, the Ombudsman’s inquiry team met with representatives of the Commission and received the comments of the complainant on the report of the meeting.[14]

Arguments presented to the Ombudsman

Evidence on which the implementing regulation was based

10. The complainant noted that existing scientific evidence considers that both transcranial magnetic stimulation and low output transcranial electric stimulation are safe treatments with few and mild side effects. In the complainant’s view, the implementing regulation mentions risks that are false and/or not based on the most recent scientific evidence. In addition, it lists all risks as common to all devices without differentiating between the different technologies used for brain stimulation.[15]

11. It argued that the Commission based the implementing regulation on outdated and insufficient sources. It said that only five of the sources used by the Commission to prepare the implementing regulation refer to brain stimulation devices. One is entirely based on another one and only three are peer-reviewed. In addition, they are all outdated: the most recent dates from 2018 (and the complainant contends it is not relevant) and all the others date from 2013 or 2014. The complainant also argued that the sources refer to mainly ethical and legal risks, which are not supported by scientific evidence. Nevertheless, the Commission presented these risks as being evidence-based in the implementing regulation.

12. The complainant added that over one thousand peer-reviewed articles are published every year on the matter and that, had the Commission used more recent sources, it would have reached a different conclusion on the reclassification of brain stimulation devices.

13. The complainant noted that the Commission published the draft implementing regulation only two weeks after having received the request from the Member States. In the complainant’s view, this shows that the Commission simply trusted the sources provided by the Member States without reviewing the most recent scientific expertise in the field.

14. During the meeting, the Commission representatives noted that the request received from the Member States was the first request for reclassification received since the entry into force of the MDR. It noted that the MDR does not establish a threshold of ‘new scientific evidence’ for the reclassification of devices nor does it set out how such evidence should be assessed.[16] The MDR states that the Commission should consult the relevant experts of the MDCG before taking a decision.[17]

15. As the Commission is not a scientific body, it has to rely on the evidence provided by the relevant Member States’ experts and on the advice of the MDCG, whose members are appointed on the basis of their expertise in the field.

16. Regarding the evidence used, the representatives of the Commission stated that it considered that five of the sources provided by the Member States are relevant for brain stimulation devices. These papers were provided by Member States’ experts and they are all published in well-known journals by reliable institutions. When it received the list of sources, the Commission verified whether they supported the risks mentioned by the Member States in their request. The Commission also consulted the MDCG on the draft reclassification implementing regulation. On this basis, it considered that the evidence provided was sufficient to support the request set out by the Member States in their letters.

17. The Commission representatives also noted that, as products without an intended medical purpose can be used without the supervision of health professional, it is necessary to consider carefully every possible risk that a product might entail. According to the MDR, products without a medical purpose should not present any risk or the risk should be low.[18]

18. The complainant commented on the position expressed by the Commission representatives. It clarified that the purpose of the complaint is not to change the risk classification for non-medical use of the devices, but rather to prevent the implementing regulation having unintended negative impacts on medical or research purposes. The complainant noted that the risks associated with brain stimulation devices in the implementing regulation are not presented as related to the non-medical use of the technologies, but rather as inherent risks. This has implications going beyond the non-medical use of the devices and affecting any use. The complainant said that it already experienced issues both for medical and research uses, as ‘notified bodies’[19] and ethics boards have already started to refer in their work to the risks mentioned in the implementing regulation.

19. Regarding the sources used by the Commission, the complainant noted that, while the MDR does not establish a clear threshold for new scientific evidence, the sources used by the Commission cannot, under any circumstances, be considered as new. In the complainant’s view, the volume of new sources not taken into account in the context of the reclassification clearly shows how the evidence used was not new within the meaning of the MDR.

20. The complainant argued that, while the Commission claims not to be a scientific body, it acted as such. It assessed the scientific evidence provided by the Member States, identified the risks mentioned by them and checked whether they were consistent with their request. In the complainant’s view, these actions show that the Commission did perform scientific work. In addition, the complainant argued that the Commission went beyond the statements made by the Member States in the letter by adding, in the implementing regulation, a statement that modifications to neuronal activity in the brain can have long-lasting effects and that any unintended effects may be difficult to reverse. In the complainant’s view, reaching such a conclusion means that the Commission performed the work of a scientific body.

21. The complainant also took the view that none of the actors involved in the procedure had the relevant competence or expertise to perform the necessary scientific work to support the statements in the implementing regulation. In the Member States’ letter, there are no references to any experts or qualified personnel having provided scientific data and nothing suggests that the sources used were gathered by experts in the Member States. There are no indications that experts in the Member States have conducted scientific research and concluded that there was sufficient scientific evidence to establish the risks of the technologies. Regarding the MDCG, the complainant noted that it is a regulatory body and not a scientific one. Members of the MDCG are experts representing the ‘competent authorities’ of the Member States,[20] but they are not required to have any specific expertise in medical or scientific fields that could be relevant for brain stimulation technologies. It is also unclear to what extent the MDCG took part in the reclassification. It is thus questionable whether the involvement of the MDCG could be sufficient to ensure the quality of the scientific evidence used.

Consultation of stakeholders

22. The complainant argued that the Commission failed to involve the relevant stakeholders in the process. In particular, it noted that the Commission received only 21 responses to the exercise it carried out seeking feedback on the draft implementing regulation. It noted that, in the context of another implementing regulation related to the MDR, the Commission collected much wider feedback (2 225 feedback instances) during an equivalent period.[21] In the complainant’s view, the failure to consult stakeholders sufficiently explains why the implementing regulation is based on poor scientific evidence.

23. The Commission stated that it collected feedback from stakeholders following the same procedure used for any other draft implementing act related to the MDR. In practice, the Commission communicated the opening of the feedback period on the ‘Have your say’ portal and informed the members and observers of the MDCG, in particular those active in the ‘Annex XVI subgroup’, which include organisations representing manufacturers.[22]

24. The Commission noted that it has no control over the number of replies it receives and, in any case, the content of feedback is more relevant than the number. The number of responses received as feedback on the draft implementing regulation is in line with the feedback received on other implementing regulations adopted in the area. The feedback received on the other implementing regulation referred to by the complainant was exceptional, and partially explained by the fact that it had been the subject of campaigns.[23] The Commission argued that the fact the feedback exercise was conducted during the summer period did not negatively affect it, as the number of responses is in line with the feedback received during other periods.

25. The complainant further argued that the implementing regulation has implications that go beyond Annex XVI products. Consequently, the Annex XVI subgroup was too narrow, in terms of expertise and representation, to cover all aspects of the reclassification of brain stimulation devices. Neither the European Society for Brain Stimulation nor the main scientists active in the field were consulted. The complainant further argued that the members of the Annex XVI subgroup are not stakeholders for brain stimulation technologies specifically. None of the members of the subgroup represents brain stimulation manufacturers, contrary to what the Commission claimed. It added that the member of the subgroup with the greatest knowledge of brain stimulation technologies publicly objected to the draft implementing regulation during the feedback period.

26. The complainant argued that, given the number of people impacted, directly or indirectly, by the reclassification, the feedback received by the Commission was clearly insufficient. In the complainant’s view, this was not due to a lack of interest in the reclassification, but to the Commission’s failure to reach the relevant audience.

27. Regarding the quality of the feedback, the complainant noted that out of the 21 responses, only four referred to brain stimulation devices. These four were highly critical of the draft and three specifically referred to the draft classifying equipment intended for non-medical purpose in a higher risk category than the same equipment intended for medical purpose. The complainant noted that, regardless of the negative feedback received, there were no changes to the draft and argued that it is unclear how the Commission followed up on this negative feedback.

The Ombudsman's assessment

28. The Ombudsman’s inquiry concerns the procedure that led to the adoption of the implementing regulation. In particular, the Ombudsman is inquiring into whether the Commission followed the relevant rules set out in the MDR and the Commission’s Better Regulation guidelines and principles.[24] The inquiry does not concern the decision to reclassify brain stimulation devices as class III as such. Nor will it review any assessment regarding the classification of devices under the MDR.

29. The MDR sets out that, “at the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: [...] 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”.[25]

30. According to EU case-law,[26] the Commission should, as a matter of good administration and in line with its duty of care, use all means available to it to ascertain the relevant facts and circumstances on which it bases the acts it adopts. Deriving from this, in the context of its responsibilities under the MDR, it is the Commission’s duty to verify that the conditions for the reclassification of the devices provided for in Article 51(3) of the MDR are fulfilled before adopting an implementing act.

31. The Ombudsman considers that, in dealing with requests for the reclassification of devices under the MDR, the Commission should therefore ensure that the evidence provided in such requests is comprehensive and representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. Doing so would appear necessary for implementing acts to comply with the conditions in Article 51(3)(b) of the MDR.

32. From the information provided by the Commission representatives during this inquiry, it is clear that the Commission based the draft implementing regulation solely on the scientific sources listed by the Member States in their request. In doing this, the Commission checked whether the sources provided were consistent with the Member States’ request, but it did not verify whether those sources included the most up to date evidence concerning the devices in question nor that there was no other conflicting scientific evidence that would have led to a different conclusion on the reclassification. In this sense, the Ombudsman considers 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 MDR, ‘new scientific evidence’ would justify the reclassification of the products.

33. While the Ombudsman acknowledges the Commission’s arguments that it is not a scientific body and that it has only limited resources, she considers that the Commission should still have verified whether the evidence provided by the Member States was comprehensive and representative of the most recent scientific evidence published on the risks linked to the use of brain stimulation devices. Given that the sources provided by the Member States mostly dated from 2013 and 2014, it should have been apparent to the Commission that this was not the case. Basing the draft implementing regulation only on the evidence provided with the Member States’ request, without taking into account what other evidence might exist, suggests that the Commission did not comply with its duty of care.

34. If the Commission considers that it does not have the necessary expertise or resources to itself carry out reviews of the latest evidence or scientific literature in the context of dealing with requests for reclassification of devices, it should ensure that this is addressed. Doing so would ensure it is acting in line with its commitment in the Interinstitutional Agreement on Better Law-Making that “[...] whenever broader expertise is needed in the early preparation of draft implementing acts, the Commission will make use of experts groups, consult targeted stakeholders and carry out public consultations, as appropriate”.[27]

35. In this context, the Ombudsman notes that the feedback received by the Commission on the draft implementing regulation was very limited. What feedback it did receive did indicate that stakeholders may have problems with the reclassification.

36. The Ombudsman accepts that the Commission followed the same procedure as for other implementing acts under the MDR and that the feedback received was in line with that received in relation to other implementing acts. The Commission cannot proactively contact any potential stakeholder interested in an act on which it is consulting. It is stakeholders’ responsibility to follow the policy development in the fields in which they are interested and to take the opportunity to provide the Commission with their comments during the feedback period.

37. That said, the Ombudsman notes that the Commission opened the draft implementing regulation for feedback for four weeks during the summer holidays. Clearly, this is an unfavourable period for receiving extensive stakeholder feedback on a draft implementing act, and the timing might have prevented stakeholders, such as the complainant, from expressing their concerns before the adoption of the act. In the interest of ensuring evidence-based decision making, the Commission should seek to ensure that it receives extensive feedback from those with practical and scientific expertise in such specialist fields.

38. Furthermore, at the time of the feedback exercise, the Commission did not disclose the list of sources provided by the Member States to justify the reclassification of the devices. Had the Commission published the list together with its draft implementing regulation, stakeholders could have critically assessed it and provided their feedback to the Commission on the adequacy of the evidence on which the draft implementing regulation was based. This could have helped the Commission verify whether the sources provided by the Member States were sufficient to support the request for reclassification.

39. More generally, as it appears that the Commission has so far always received limited feedback in relation to draft implementing regulations under the MDR, it could reflect on whether it should do more to raise awareness among relevant experts and stakeholders.

40. In light of the above, the Ombudsman proposes that the Commission now verifies 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.

The proposal for a solution

Based on the above findings, the Ombudsman proposes that the Commission now verifies whether the scientific evidence provided with the Member States’ request 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.

The Commission is invited to inform the Ombudsman by 13 February 2024 of any action it has taken in relation to the above solution proposal.

 

Emily O'Reilly
European Ombudsman

Strasbourg, 08/11/2023

 

[1] Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.253.01.0001.01.ENG&toc=OJ%3AL%3A2021%3A253%3ATOC

[2] Regulation (EU) 2017/745 of 5 April 2017 on medical devices, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745.

[3] 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

[4] 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”.

[5] 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”.

[6] More information on the comitology process: https://commission.europa.eu/law/law-making-process/adopting-eu-law/implementing-and-delegated-acts/comitology_en.

[7] 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.

[8] 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.

[9] 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.

[10] Section 6 of Annex XVI to the MDR.

[11] Commission Implementing Regulation (EU) 2022/2347, Article 1

[12] 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.

[13] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en

[14] https://www.ombudsman.europa.eu/en/doc/inspection-report/en/170462.

[15] Recital 7 of Commission implementing regulation 2022/2347 reads as follow:  

“According to available scientific evidence on equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745, such as those for transcranial magnetic stimulation or transcranial electric stimulation, the use of such products may cause side effects, for example, atypical brain development, abnormal patterns of brain activity, increase metabolic consumption, fatigue, anxiety, irritability, headaches, muscle twitches, tics, seizures, vertigo and skin irritation at the electrode site. While such equipment is not surgically invasive, the electrical currents or magnetic or electromagnetic fields do penetrate the cranium to modify neuronal activity in the brain. Such modifications can have long-lasting effects and any unintended effects may be difficult to reverse. Such products should therefore be classified as Class III.”

[16] 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:

[...]

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”.

[17] MDR, Article 51(6).

[18] MDR, Annex I, section 9 reads as follows: “For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons”.

[19] Notified bodies are conformity assessment bodies designated by an EU Member States.

[20] Rules of procedure of the MDCG, https://health.ec.europa.eu/system/files/2022-01/md_dialogue_mdcg_rules_procedure_en.pdf.

[21] Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346.

[22] The list of observers in the MDCG is available on the Register of Commission Expert Groups and Other Similar Entities, https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupID=3565. The Commission clarified that of the 34 observers in the MDCG, the following 12 are active in the Annex XVI subgroup:

1. AESGP (Association of the European Self-Medication Industry);

2. APPLiA (Home appliance Europe);

3. COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry);

4. EAAR (European Association of Authorised Representatives);

5. ECOO (European Council of Optometry and Optics);

6. Euromcontact (represents the European Manufacturers of contact lenses and lens care products);

7. GIRP (European Healthcare Distribution Association);

8. MedTech Europe (European trade association for the medical technology industry including diagnostics, medical devices and digital health);

9. SMEunited (Crafts & SMEs in Europe);

10. Team-NB (European Association of Notified Bodies for Medical Devices);

11. NB-MED (Notified Bodies Coordination Group);

12. EUROM 1 (European Federation of Precision, Mechanical and Optical Industries).

[23] Out of 2225 feedback instances, 1153 were collected through campaigns, https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11629-Products-with-an-aesthetic-or-non-medical-purpose-safety-requirements_en.

[24] https://commission.europa.eu/law/law-making-process/planning-and-proposing-law/better-regulation/better-regulation-guidelines-and-toolbox_en.

[25] MDR, Article 51(3).

[26] Judgment of the General Court of 7 March 2019, Sweden v. Commission, T-837/16, paras 64 and following, https://curia.europa.eu/juris/document/document.jsf;jsessionid=9187C75B914FB95EE65030714F0E836E?text=&docid=211428&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=473069 - this judgment can be applied by analogy to this case.

[27] Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making, OJ L 123, 12.5.2016, Point 28, second subparagraph, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016Q0512%2801%29.