The French competent authority (ANSM) has published information for medical devices containing COBALT further to the publication of the Commission Delegated Regulation (EU) 2020/217 amending and correcting Regulation (EC) No 1272/2008 of the European Parliament and the Council on classification, labeling and packaging of substances and mixtures. This delegated regulation amends Annex VI of the CLP Regulation 1272/2008, which lists all substances that the European Chemical Agency (ECHA) has classified as hazardous, having specific labeling and packaging requirements.
Therefore, the ANSM informs manufacturer that as of October 1, 2021, cobalt will be classified as follows:
- Carcinogenic 1B
- Mutagenic 2
- Toxic for reproduction 1B
Thus, from October 1, 2021, if the use of this substance is present in the medical device with quantities above 0,1% w/w, it would be necessary for the manufacturer to be compliant with the requirements set in Annex I, Chapter II, point 10.4 of the Medical Device Regulation 2017/745, which are the following:
- Justify the use of cobalt: As the ANSM explains, this can be done by showing proof that no other substance can replace cobalt in the medical device;
- Indicate the presence of cobalt through specific labeling;
- Provide information on residual risks and, if applicable, on appropriate precautionary measures If the intended use of such devices includes treatment of children, or treatment of pregnant or breastfeeding women, or treatment of other patient groups considered particularly vulnerable to such substances and/or materials.
These requirements are the same of CMR 1A and 1B substances, as well as Endocrine-disruptors listed in the CLP Regulation 1272/2008, which apply to medical devices listed in article 10.4.1. of Annex I Chapter 2 MDR:
- Devices that are invasive and come into direct contact with the human body;
- Devices that (re)administer medicines, body-liquids or other substances, including gases, to/from the body; or
- Devices that transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body.
Please note that MDR Annex 1 -10.4.5 further specifies that if the intended use of such devices includes treatment of children, or treatment of pregnant or breastfeeding women, or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
Nevertheless, please note that cobalt is currently not listed as a Substance of Very High Concern (SVHC). Consequently, the use of cobalt in medical devices is not prohibited for the time being.
To address any possible queries, the ANSM provides clarity on the matter through a Q&A section in the French language.
Are you interested in knowing more about hazardous substances and specific MDR requirements? Please do not hesitate to contact us. We can assist you on your path towards MDR compliance for your medical devices.
Pablo De Mingo Monge
Publications department
16.11.2021
References:
EUR Lex. (4 October 2019). Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation (Text with EEA relevance)Text with EEA relevance. Retrieved on 16/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02020R0217-20200218
EUR Lex. (5 April 2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)Text with EEA relevance. Retrieved on 16/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424
EUR Lex. (16 December 2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance). Retrieved on 16/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). (1 October 2021). Évolution règlementaire impactant les dispositifs médicaux qui contiennent du cobalt.Retrieved on 16/11/2021 from https://ansm.sante.fr/actualites/evolution-reglementaire-impactant-les-dispositifs-medicaux-qui-contiennent-du-cobalt