Excluded Compound Testing

Exclusion Testing for Material Compliance Regulations of Medical Device Components

Multiple regulating bodies (MDR, REACH, RoHS, the State of California) have prepared lists of harmful or potentially harmful compounds that are to be excluded from various commercial products. Specifically, MDR guidelines require collection of data and documentation that medical devices do not contain carcinogens, mutagens, or reproductive toxic substances.

Companies who import products into Europe are required to disclose the materials of construction to various regulating bodies. Often, manufacturers rely on their material and component suppliers for this information. However, in many cases, suppliers are either not forthcoming with this information or a manufacturer might want to confirm the supplier’s information. Therefore, the manufacturer needs to perform analytical testing to demonstrate the absence of excluded compounds.

Regulations

Medical Device Specific

  • MDR section 10.4 (CMR 1a/1b and ED)

Non-Medical Device Specific

  • REACH 1907/2006 Article 33 (SVHC)
  • REACH 1907/2006 Article 67 (Restricted)
  • RoHS 3 (2015/863)
  • RoHS 2011/65
  • POP 850/2004
  • Prop 65

Our Approach to Exclusion Testing

EAG has compiled a master list of more than 4,000 excluded compounds. We have assessed each of the compounds present from a scientific standpoint to address the likelihood of each compound being used in a medical device. This drastically reduces the number of compounds that need to be screened. EAG scientists perform screening for the remaining compounds using several different analytical methods including:

  • Material Identification via XRF and FTIR
  • Sample Extraction and Screening by LCMS and GCMS

EAG is your partner in meeting pertinent regulatory guidelines. We can customize an approach to meet your specific needs:

  • One of our dedicated Program Directors will prepare protocol, organize work and data, and lead the scientific team
  • A protocol specific to your components will be provided for your review
  • We provide weekly updates and discussion of program progress
  • Full and comprehensive reporting of data and conclusions will be provided

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