Mandatory labelling of CMR substances in implants and their impact on orthopedics and trauma surgery

With the commencement of EU Regulation 2017/745 (Medical Device Regulation, MDR), a justification and labelling obligation for medical devices was introduced for substances (chemicals, elements) that are proven or suspected to be carcinogenic, mutagenic or toxic to reproduction (CMR substances). This also applies to substances having endocrine disrupting properties. This obligation has led to great concern in the industry and among medical professionals, particularly with regard to possible uncertainty on the part of patients and users. The aim of this article is to clarify the most important context in order to counteract these concerns. For patients, the CMR labelling requirement will not result in any changes in the quality of care. On the other hand, the medical profession has the additional task of conveying a sense of security to their patients despite an uncontrollable public debate. The use of a ceramic head instead of a metal head in hip joint replacement can be cited as an example here. CMR-labelled implants pose only a very low risk to the patient due to the material, which only occurs in very rare cases if the restoration fails. In the future, however, manufacturers must aim to qualify more CMR-free materials. However, this is a cost- and time-intensive endeavour under the regulations of the MDR with high requirements, particularly with regard to clinical efficacy. The well-established tried-and-tested implant materials have proven to be clinically successful even in difficult revision situations. Switching completely to a different material without the corresponding clinical experience could potentially lead to losses in component safety. The implementation of the CMR labelling requirement should be closely monitored by both the medical profession and manufacturers in order to counteract any uncertainty among patients at an early stage.

Subjects

CMR

cobalt

hazardous substances

implant

labeling

DDC Class

610: Medicine, Health

363: Other Social Problems and Services

340: Law

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https://creativecommons.org/licenses/by/4.0/

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publishedVersion

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a-2761-5480.pdf

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Main Article

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484.27 KB

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Mandatory labelling of CMR substances in implants and their impact on orthopedics and trauma surgery