European Ombudsman suggests Commission needs more robust evidence when reclassifying medical devices

Quick background: The European Ombudsman fields citizens’ complaints on Union institutions

• The legal basis for a European Ombudsman comes from Article 228 of the Treaty on the Functioning of the European Union (TFEU). The European Parliament elects the European Ombudsman, which is intended to serve as an administrative oversight mechanism. Duties for this body include receiving complaints from any citizen of a Member State “concerning maladministration in the activities of the Union institutions, bodies, offices or agencies…He or she shall examine such complaints and report on them.” If the ombudsmen find grounds based on those complaints, they may initiate an inquiry. If the issues are confirmed during the inquiry, the matter is referred to the affected institution or agency concerned, which has three months to report back. The ombudsmen will then forward their reports to the Parliament and the agency concerned.

In early 2023, the Ombudsman received a complaint on the European Commission’s reclassification regulation on brain stimulation devices.

• A quick recap on Ombudsman case 157/2023/VB [see here for previous AgencyIQ explainer]: A neuroscience company submitted a complaint to the Ombudsman shortly after the Commission’s reclassification implementing regulation ( Commission Implementing Regulation (EU) 2022/2347) was published in the Official Journal. The implementing regulation was intended to address a concern brought to the Commission’s attention by six Member States. The complainant pointed out that certain active devices with no medical purpose described in Annex XVI of the European medical device regulation (MDR; Regulation (EU) 2017/745) defaulted automatically to the lowest risk class because of the lack of intended medical purpose, even if their use represented significant risk to the patient. The regulation placed brain stimulation devices into the highest risk class, class III, because of this classification scheme.
• The complaint alleged failure to follow the law in the preparation of the draft implementing regulation. While the Commission engaged the Medical Device Coordination Group (MDCG) to provide current evidence on brain stimulation devices, which were one of the reclassified products, the complainant felt the evidence provided was outdated and insufficient, and further asserted that the Commission solicited very little feedback before implementing the regulation. In presenting its own evidence, the company noted that “over one thousand peer-reviewed articles are published every year and that, had the Commission used more recent sources, it would have reached a different conclusion.”
• The Ombudsman had two questions on the Commission’s process for its evidence-based approach. The Ombudsman asked the Commission to respond to the assertion that the articles cited to reclassify brain stimulation were “extremely limited…, outdated and, in certain cases, not peer reviewed.” The second question asked for clarification on the actions the Commission took when it received the reclassification request from the Member States, focusing on how the Commission evaluated the scientific evidence and decided that it was sufficient – and sufficiently new – to reclassify brain stimulation equipment.
• In the Commission’s response, it asserted that it used both an evidence-based approach and a sound feedback process. One of the purposes of the MDCG, as outlined in MDR Article 105(f) and (g), is to assist Member States and the Commission and offer scientific advice. The Commission responded to the complaint that the five scientific papers on brain stimulation devices provided by the MDCG offered information on potential risks of these products. Additionally, it outlined the public feedback it undertook via the Have your say mechanism on the proposed reclassification. [ Read AgencyIQ’s assessment of the feedback received.]
• The complainant continued to take exception to the Commission’s response, however. While acknowledging the Have your say feedback, the complainant noted that there were only 21 responses, and just four of those related to brain stimulation devices. Notably, those four were “highly critical” of the reclassification and disagreed with putting equipment intended for no medical purpose into a higher risk class than the same ones used for a medical purpose. It also pointed out that neither the European Society for Brain Stimulation nor any scientists active in the field were consulted.

The Ombudsman assessed the case and offered solutions to the Commission, but it’s not apparent whether the Commission has responded to the suggested solutions

• The Ombudsman’s assessment is limited to whether or not the Commission followed its processes. The Ombudsman doesn’t take a stance on the appropriate classification of brain stimulation devices, but instead focuses on whether the Commission followed the requirements of the MDR and its own Better Regulation guidelines and principles.
• Finding: The Commission relied on scientific advice that was both limited and old. The Ombudsman pointed to a statement in the MDR that, upon a request for reclassification, the Commission will make the decision based on new scientific evidence that is comprehensive and representative. In this case, however, the Ombudsman asserts that the Commission made the decision based “solely on the scientific sources listed by Member States in their request,” which all came from 2013 and 2014. Per the Ombudsman’s review, the Commission didn’t confirm that the evidence was current or if there was any conflicting evidence, which should be necessary in enacting implementing acts supporting reclassification, according to MDR Article 51(3)(b). Where the Commission doesn’t have sufficient expertise, the Ombudsman felt it should have made use of expert groups.
• There were also problems with the public feedback process on the proposed reclassification. Regarding the open feedback via Have your say, the Ombudsman agreed that the Commission followed the same procedure it used for other implementing acts, but further noted that having it during the summer holidays was an “unfavourable period for receiving extensive stakeholder feedback.” The Ombudsman also noted that not disclosing the list of sources at the time of the feedback didn’t allow the stakeholders to assess and provide feedback on the sources as to their adequacy.
• Suggestions for the Commission include verifying the evidence. The Ombudsman suggested that the Commission needs to verify whether the evidence used to finalize the reclassification of brain-stimulating devices was comprehensive, representative and current as to the risks of the devices. Further, if the Commission finds the more recent evidence doesn’t support the reclassification, it should “adopt a new implementing act, on its own initiative, based on Article 51(4) of the MDR.”
• In general, the Commission should do more in its feedback efforts. “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.”
• The Commission’s response, if any, hasn’t yet been posted. The Ombudsman asked the Commission to respond describing any actions taken by February 13, 2024, but case 157/2023/VB doesn’t yet indicate whether the Commission responded by that date or what its response might have been.

Analysis

• In this complaint against the Commission, the Ombudsman generally agreed with the complainant. The Ombudsman recognized that the Commission followed some of its processes as expected. However, the office further found that the Commission deviated from those expectations by not verifying if the evidence presented was new evidence; neither did the evidence appear to be comprehensive or representative. While the MDCG is tasked with advising the Commission, in this case, it appeared to accept the articles that the Member States presented in their request for reclassification without verifying the representativeness of those articles, and the Commission didn’t question the approach.
• Especially concerning was that the only evidence examined to support reclassification came from the very Member States asking for the reclassification. The Ombudsman specifically criticized the Commission’s willingness to accept a few articles a decade or more old as being current and representative, especially since the complainant pointed out that yearly, hundreds of articles are published on the topic.
• The Ombudsman suggested that the Commission needs to take a deeper look at the evidence that brain stimulation devices are high risk and perhaps issue a correcting regulation if it finds the evidence doesn’t support the original reclassification. In general, the Commission should ensure that it engages sufficient experts and stakeholders to ensure it has used new scientific evidence to support its reclassification decisions.
• While the Commission had until February 13, 2024 to respond, no response has been added to the complaint case. We don’t know if this means the Commission didn’t offer a response by that date, or if its response just hasn’t been added to the case yet.
• What this might mean for manufacturers of brain stimulation devices with no medical purpose: Given the Ombudsman’s recommendations, it’s possible that the Commission could issue a correcting regulation to alter the current classification of these devices as the highest risk, but it would likely be some time. To do this, the Commission would need to collect and analyze current evidence and evaluate whether a reclassification is warranted, which would presumably go through another public consultation – although hopefully, the summer recess could be avoided his time.

To contact the author of this item, please email Corey Jaseph ( cjaseph@agencyiq.com).
To contact the editor of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com) or Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• • • Proposal for a solution 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)