Restricted Substances under the New Medical Devices Regulation
Number of restricted substances will increase every year
22 June 2020
In addition to addressing requirements for nanomaterials, one of the unique additions to the Medical Devices Regulation (EU) 2017/745 (“MDR”), is the regulation of carcinogenic, mutagenic or toxic to reproduction (CMR), and/or endocrine-disrupting substances. As per the new MDR, medical devices can not contain CMR and/or endocrine-disrupting substances in a concentration above 0.1% weight by weight/components.
Currently, there are more than 1,000 substances regulated under the MDR, and the number will continue to rise every year. Since collecting information about the presence of regulated chemical substances will be overwhelming, and lab testing will not be an option for controlling thousands of substances, other risk assessment and mitigation methods are recommended. These methods should be included in the corresponding technical file for each medical device.
In cases where CMR and/or endocrine-disrupting substances must be used, documentation must include a justification and clarification to support that there were no alternatives available or that there were not additional exposure or risks for the patients, in addition to a risk-benefit analysis. Chemical regulation requirements under the new MDR do not affect other chemical management regulations like the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Persistent Organic Pollutants (POP) or the Restriction of Hazardous Substances (RoHS) directive. Therefore, the best option to comply with the many existing chemical regulations is to have a unified chemical management system that begins at the design phase and continues to manage the supply chain throughout production.
Furthermore, per the MDR, the presence of CMR and/or endocrine-disrupting substances above the threshold shall be communicated using a label on the device itself and/or on the packaging for each unit. The information labelled should be submitted using the Unique Device Identification (UDI) Database along with the Basic Unique Device Identification-Device Identifier (UDI-DI). If the intended use of such devices includes treatment of special patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups must be provided.
Under MDR, manufacturers are required to have at least one person responsible for regulatory compliance that possesses the requisite expertise in the field of medical devices. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the EU market if the manufacturer designates a sole authorized representative within the EU. If you are a manufacturer in the European Union (EU) or you would like to outsource this role and responsibility, Intertek can help. Our scientific and regulatory experts are available to assist companies in meeting MDR compliance requirements.
For further information on how Intertek can help you place your medical devices onto the EU market, please don't hesitate to contact us.