According to regulation no. (EC) 1272/ 2008, Annex VI part 3, the substances that are carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B are considered as the “CMR” substances. Category 1 A are the known human carcinogen, mutagen or reproductive toxicant based on human evidence whereas category 1 B is based on the animal studies. CMR category 1 A and 1B substances in the table 3.1 of annex VI of the above regulation are restricted by REACH.
The substances assigned with the hazard statement code H340, H350, H360 in that table will be restricted under REACH. “Endocrine -disrupting substances” or endocrine disruptors are the chemicals that impact on the human and animal hormonal system under certain conditions. There are scientific evidences for the serious effects on the humans.
As per the EU MDR 2017/745, CMR and/ or endocrine -disrupting substances should be present in concentration below 0.1% weight by weight (w/w). If the concentration is above the specified limit in the medical device, then justification should be drawn based on the below points
- ~ Analysis and estimation of the potential patient or user exposure to the substance. Here the relevance of the biological evaluation based on the standard ISO 10993-1 and testing of the medical device within a risk management process.
- ~ Availability of possible alternative designs, materials or substances based on the literature reviews or independent researches
- ~ If the possible alternatives are available, check the feasibility, functionality, risk- benefit ratios of the product including the intended use and the intended population with any special consideration.
- ~ Compare those alternatives with the treatment CMR and /or endocrine disruptors for the functionality, hazards of use and non-use scenario, benefit risk ratio.
- ~ Analysis on any uncertainty
Overall summary report based on the above justifications for the continued use of the CMR/ED phthalates according to the Annex I clause 10.4 of EU MDR. The labelling should contain the list of the above-mentioned substances with its concentration. If the patient groups include the children, pregnant or breast-feeding women or treatment of other vulnerable group to the substance, then information on the residual risks and the precautionary measures shall be given on IFU.