The Medical Devices Regulation (EU) 2017/745 (“MDR”) addresses the clinical investigation and sale of medical devices for human use.
The MDR regulates carcinogenic, mutagenic or toxic to reproduction (CMR) substances, and endocrine-disrupting (ED) substances. Specifically, medical devices cannot contain CMR and/or ED substances in a concentration above 0.1% weight by weight.
The EU MDR regulated substances are referred to in Chapter II Section 10.4 of Annex I of EU MDR. This Annex identifies three lists:
(1) Substances which are “…carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.”
This refers to the European Commission’s Classification, Labelling, and Packaging (CLP) Regulation, whose Annex VI provides a detailed list of chemicals. Category Codes allow identification of substances known to be carcinogenic, mutagenic, or toxic to reproduction.
(2) Substances with “…endocrine-disrupting properties…identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council.”
This refers to the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation, specifically substances on the REACH SVHC Candidate List known to have endocrine-disrupting properties, as indicated in the “Reason for inclusion” field in the List.
(3) Substances with “…endocrine-disrupting properties…pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012.”
This refers to Article 5 (Item 3) of the EU Biocidal Properties Regulation (BPR). The European Chemicals Agency (ECHA)’s Endocrine Disruptor Assessment List gives assessment status for substances considered to be potential endocrine disruptors under EU BPR or the REACH Regulation.