Dear Ms X,

On 6 May 2019, you submitted a complaint^[1] to my Office against the European Commission concerning its failure to deal adequately with your infringement complaint (CHAP(2017)03487) against the Netherlands.

Your infringement complaint to the Commission concerned an alleged breach of Council Directive 93/42/EC on medical devices (the Medical Devices Directive). You contend, among other things, that the Dutch Healthcare Inspectorate failed to treat substances in breast implants as ‘medicinal substances’.

In your view, the Commission based its decision to close the infringement complaint on the wrong reasons. You further state that the Commission should investigate the facts of the case, rather than merely relying on the views of the Dutch authorities.

I would first like to express my understanding for your personal situation and my appreciation for the work that your organisation is doing to help other women.

After a careful analysis of all the information submitted to me, however, I am sorry to have to inform you that I do not find that the Commission’s response to you amounts to maladministration.

I note that the Commission has explained that it will not open infringement proceedings as it considers that the information you have provided to it is not sufficient to show that there was an infringement of the Medical Devices Directive. Specifically, the Commission stated that you have not provided it with evidence of the existence of a non-approved medicinal substance in breast implants. On this basis, the Commission closed the case.

The Commission’s explanation, to my mind, is reasonable.

Separate from my assessment as regards whether the Commission has adequately explained to you why it will not open infringement proceedings, I take note of the fact that you disagree with the Commission’s scientific assessment. The Ombudsman is not a scientific body and cannot conduct a scientific assessment as to whether substances should be considered ‘medicinal substances’. The Ombudsman therefore cannot assess whether, as a matter of science, the Commission was wrong.

I also note that the regulation of the safety of medical devices, such as breast implants, is currently a Member State responsibility^[2]. The European Commission therefore has no competence to evaluate if any given medical device is safe. As a result, I consider that the Commission did not err when it contacted the Dutch authorities to seek their views on the matter.

I understand that this might not be your desired outcome but I hope you find the above explanations useful.

 

Yours sincerely,

 

Emily O'Reilly
European Ombudsman

Strasbourg, 18/06/2019

 

[1] Full information on the procedure and rights pertaining to complaints can be found at https://www.ombudsman.europa.eu/en/document/70707.

[2] The legal framework has been revised through legislation that will repeal Council Directive 93/42/EC and which will apply from 26 May 2020. See for more information: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745.