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Data source EUR-LEX
  • 1182
2019-12-02

Chemical Requirement of Medical Device Regulation (MDR)

Certain devices, or those parts thereof or those materials used therein have contain CMR 1A, 1B, or EDCs in a concentration higher than 0.1%, the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit.

  • MDR Regulation(EU) 2017/745 has been adopted:
    • On 25th May, 2017
    • 3 years’ transition period, and will take effect on 26th May, 2020
    • MDR will replace AIMD (90/385/EEC) and MDD (93/42/EEC)
  • According to Article 52 and 10.4.1 of Annex I of MDR, if devices, or those parts thereof or those materials used therein have met the following anyone of conditions:
    • are invasive and come into direct contact with the human body or,
    • (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
    • transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
    Devices, or those parts thereof or those materials used therein shall avoid to contain the following substances above >0.1(w/w)%
    • substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP) of the European Parliament and of the Council, or
    • substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the criteria that are relevant to human health amongst the criteria established therein.
  • The abovementioned medical device, part or material contains CMR 1A & 1B in CLP or REACH EDCs substances > 0.1% (w/w), then the following action shall be accomplished:
    • the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
    • If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
  • CMR 1A & 1B under CLP and REACH EDCs contain nearly 1,200 substances. SGS only tests relevant High Risk Substance according to the different classified materials of medical device
High Risk Substance screening test of
  • CMR 1A & 1B substances in Regulation (EC) 1272/2008 Part 3 of Annex VI and
  • EDCs in Regulation (EC) No 1907/2006 SVHC candidate list
Tested Material Plastic Rubber Silicone Rubber Metal/
Plating
Glass/ Ceramic Paint/ Ink/
Dye/ Coating
Leather Textile/
Cotton
Paper Wood
Sample Size (g) 45 60 45 20g+50cm2 5 65 55 55 35 50
Note
  1. Only test homogenous materials that are invasive and assessable to human body.
  2. Only detected high risk substances with concentration > RL “500 ppm” will be listed on the screening report. If all tested high risk substances are n.d., the test results are expressed as “All tested MDR substances : n.d.”
  3. Inorganic item can’t be analyzed directly per the current available technique and instrument. Thus, the specific element(s) of inorganic item will be analyzed and calculate the concentration of inorganic item based on the specific element(s).

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