Dealing with harmful substances found in medical devices. It was officially implemented on May 26, 2021.
goal:
Medical Device Regulation (EU) 2017/745 ("MDR") introduces notable regulations regarding the regulation of carcinogenic, mutagenic, or reproductive toxicity (CMR) and/or endocrine disruptors. According to MDR, medical devices must not contain CMR and/or endocrine disruptors at concentrations greater than 0.1% by weight (w/w) of the components. Special considerations must be paid to nanomaterials unless the nanomaterials contact only with intact skin.
Applicable products:
Devices that meet the following criteria, or components or materials used within the device.
- They are invasive and come into direct contact with the human body.
- They (re-)administer the body medicines, fluids, or other substances, including gases.
- They transport or store substances containing such medicines, bodily fluids, or gases for the purpose of (re)administration to the body.
Devices must be designed and manufactured in a manner that minimizes the risks associated with materials and particles, such as wear powders, degradation products, and processing residues that may be released from the device.
Furthermore, medical devices must not contain any substances below a concentration of more than 0.1% (w/w) in weight ratio of the product.
- Carcinogenic, mutagenic, or reproductive toxic (CMR) substances classified as CLP Rule (EC) No. 1272/2008, as defined in Part 3 of Annex VI, Category 1A or 1B.
- Substances identified as endocrine disruptors pursuant to Article 59 of REACH Regulation (EC) No 1907/2006 and Article 5(3) of Biocidal Products Regulation (EU) No 528/2012.
The current list consists of over 1,000 substances and is updated every six months, including new additions and revisions.
Manufacturer's responsibility if 0.1% w/w threshold is exceeded
The manufacturer must take the following measures:
- A profit and risk assessment is carried out and valid reasons are provided in the technical file.
- Please clearly indicate the presence of these substances on the device itself and/or the packaging of each unit. Alternatively, if applicable, the label should be attached to the sales package with a list of such substances.
- Include instructions specifically tailored for patients who are considered particularly vulnerable to these substances.
- Ensure that you maintain your Unique Device Identification (UDI) online database, which contains relevant information about medical devices.
By fulfilling these obligations, manufacturers can meet regulatory requirements and ensure the safety and transparency of their medical devices.
Ahmed Sakr
Product Compliance Consultant
ComplyMarket UG (Haftungsbeschraenkt)
