REACH authorisation impacts medical device industry
One of the hot topics impacting the medical device industry this year is REACH authorisation.
Whilst certain substances are exempt from REACH authorisation, others such as octylphenol ethoxylate (OPEs) are currently on the authorisation list. OEPs have a sunset date of 4 January 2021 and without authorisation or an exemption, the use of these substances will be illegal in the European Economic area after this date. Companies currently using OPEs in life sciences, inter alia in IVDs and medical devices, and in any other medical products, may need to apply for authorisation.
In addition, three aprotic solvents NMP (1-Methyl-2-pyrrolidone), DMF (N,N-Dimethylformamide) and DMAC (N,N-Dimethylacetamide) have been proposed for inclusion onto the REACH authorisation list. Companies using these substances in the manufacturing of medical devices and IVDs – for example in processes for enzyme production, membrane production, peptide synthesis, or in the manufacturing of synthetic antigens/antibodies – will need to develop risk mitigation plans should these substances be added to the authorisation list.
12 steps to apply for REACH authorisation
The authorisation procedure is complex and TSG has created this handy timeline outlining the 12 steps to apply for REACH authorisation. With many years’ experience guiding companies through every aspect of their REACH obligations, we can help you develop risk mitigation plans, identify technically viable alternatives to the substance of very high concern, undertake assessments to determine compliance with REACH, as well as help with REACH authorisation applications.
Please do get in touch if you're working on REACH compliance projects – we'd love to meet with you and discuss how we can assist.