It concerns the dangerous substances contained in medical devices. It was officially implemented on May 26, 2021.
Aim:
The regulations on medical devices (EU) 2017/745 (“MDR”) introduces a significant provision concerning the regulation of carcinogenic, mutagenic or toxic substances for reproduction (CMR) and/or endocrine disruptors. According to the MDR, medical devices should not contain CMR substances and/or endocrine disruptors at a concentration greater than 0.1 % weight/weight (p/p) of the components. Particular attention should be paid to nanomaterials, unless they only come into contact with intact skin.
Products concerned:
Devices, or their components or materials used in them, which meet the following criteria:
- They are invasive and go directly into contact with the human body.
- They (re) administer drugs, body fluids or other substances, including gases, towards/from the body.
- They transport or store such drugs, body fluids or substances, including gases, with a view to their (re) administration to the body.
The devices must be designed and manufactured to minimize the risks associated with substances or particles, including wear debris, degradation products and treatment residues that can be released by the device.
In addition, medical devices should not contain the following substances above a concentration of 0.1 % weight/weight (p/p) of the article:
- Carcinogenic, mutagenic or toxic substances for reproduction (CMR) classified in category 1a or 1b, as defined in part 3 of Annex VI of the CLP (EC) Regulation N ° 1272/2008.
- Substances identified as endocrine disruptors in accordance with article 59 of the REACH (EC) regulation n ° 1907/2006 and in article 5, paragraph 3, of regulation (EU) on biocidal products (EU) n ° 528/2012.
The current list includes more than 1,000 substances and will be updated every six months to include new additions or revisions.
Responsibilities of manufacturers in the event of exceeding the threshold of 0.1 % p/p
The manufacturer is required to perform the following actions:
- Carry out a benefit-risk assessment and provide justification in the technical file.
- Clearly label the presence of these substances on the device itself and/or on the packaging of each unit. Alternatively, if necessary, the labeling must be affixed to the sales packaging with a list of these substances.
- Include instructions for use specifically adapted to the groups of patients considered to be particularly vulnerable to these substances.
- Ensure the maintenance of the UDI online database (single Device Identification), which contains relevant information on the medical device.
By fulfilling these obligations, manufacturers can meet regulatory requirements and guarantee the safety and transparency of their medical devices.
Ahmed Sakr
Product Compliance Consultant
Complymarket UG (Beschraenkt)
