Medical Devices Regulation

Balancing risk and benefit: The manufacturer's obligations and 39; s for hazardous substances in medical devices and how ComplyMarket can optimize compliance

The Medical Device Regulation (EU) 2017/745 ("MDR") prescribes the regulation of substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) and/or endocrine-disrupting substances in medical devices. This article provides an overview of the regulations for CMR and/or endocrine substances in medical devices and the manufacturer's obligations if the 0.1% threshold is exceeded.

Products in scope:

Devices or parts thereof, or the materials used therein, that:

• are invasive and come into direct contact with the human body,
• administer to the body any medicine, body fluid or other substance, including gases, or
• Transport or storage of such medicines, body fluids or substances, including gases, to be (re)administered to the body.

Regulations:

• Medical devices must not contain CMR and/or hormone-disrupting substances in a concentration of more than 0.1% by weight (w/w)/components.
• Medical devices must not contain carcinogenic, mutagenic or reprotoxic substances (CMR) of category 1A or 1B according to Annex VI Part 3 of the CLP Regulation (EC) No. 1272/2008Disruption of defined substances according to Article 59 of the REACH Regulation (EC) No. 1907/2006 and Article 5(3) of Regulation (EU) No 528/2012 on biocidal products.

Manufacturer's commitments:

If the threshold of 0.1% w/w is exceeded, the manufacturer must:

• Carry out a benefit-risk assessment and include the justification in the technical dossier.
• Mark the presence of such substances on the product itself and/or on the packaging for each unit or, where applicable, on the sales packaging with the list of these substances.
• Include instructions if the application is intended for groups of patients who are considered particularly susceptible to such substances.
• maintenance UDI Online Database.

How ComplyMarket can help you:

• ComplyDoC: is an intelligent IT and first open-source code cloud solution for supply chain sustainability, chemical and product compliance management to collect and collect information from suppliers.
• Ad hoc advice: ComplyMarket team has extensive experience in providing regulatory support for the Medical Device Regulation "MDR".