It's about dangerous substances in medical devices. The official implementation took place on May 26, 2021.
Goal:
The Medical Device Ordinance (EU) 2017/745 ("MDR") introduces a remarkable determination to regulate cancer -generating, genetic -changing or reproductive (CMR) and/or endocrine -acting substances. According to MDR, medical devices may not contain CMR and/or endocrine-damaging substances in a concentration of more than 0.1 weight percent (f) of the components. Nanomaterials should be given special attention, unless they only come into contact with intact skin.
Products in the scope:
Devices or their components or materials used in them fall under the following criteria:
- They are invasive and come into contact with the human body directly.
- They admit medication, body fluids or other substances, including gases, into the body or from the body.
- They transport or store such medication, body fluids or substances, including gases, for the purpose of (re) administration in the body.
Devices must be designed and manufactured in such a way that the risks associated with substances or particles, including wear residues, dismantling products and processing residues that can be released by the device, minimize.
In addition, medical devices must not contain the following substances over a concentration of 0.1 weight percent (f/f) of the article:
- Carcinogenic, mutagenic or reproductive oxic (CMR) fabrics of category 1a or 1b in accordance with part 3 of Appendix VI of the CLP regulation (EG) No. 1272/2008.
- Substances that are classified as endocrine-damaging in accordance with Article 59 of the REACH regulation (EC) No. 1907/2006 and Article 5 (3) of the Biocidal Products Ordinance (EU) No. 528/2012.
The current list includes over 1000 fabrics and is updated every six months to record new additions or revisions.
Responsibilities of the manufacturer if the limit is exceeded 0.1 % W/f
The manufacturer is obliged to carry out the following measures:
- Perform a benefit-risk assessment and state a reason in the technical act.
- Record the presence of these substances clearly on the device itself and/or on the packaging of each device. Alternatively, the labeling together with a list of such fabrics must be attached to the sales packaging.
- Add instructions for use that are specially tailored to patient groups that are considered to be particularly susceptible to these substances.
- Ensure the maintenance of the UDI online database (Unique Device Identification), which contains relevant information on the medical device.
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 (limited liability)
