Final SCHEER Committee Phthalate Benefit-Risk Assessment Guidelines Published

Final SCHEER Committee Phthalate Benefit-Risk Assessment Guidelines Published

After a lengthy public consultation period, the European Commission’s long-awaited Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) report and benefit-risk assessment guidelines on phthalates in certain medical devices have been published.

These guidelines have specific data and reporting implications for benefit-risk assessments on the presence of phthalates in medical devices under the European Union Medical Device Regulation (EU MDR). These guidelines outline a framework for medical device manufacturers to follow when compiling technical file submissions for notified bodies.

Breaking Down the New Benefit-Risk Assessment Guidelines

Phthalates are commonly used as polymer plasticizers and can be found in a variety of industrial applications, though the medical device industry also makes use of them. The SCHEER guidelines specifically address phthalates that are carcinogenic, mutagenic and/or toxic to reproduction (CMR) or endocrine-disrupting (ED).


Learn more about the EU MDR and its requirements in our eBook, Understanding the European Union Medical Device Regulation.


The guidelines also outline 10 key steps for conducting a benefit-risk assessment:

  1. A description of the medical device in question.
  2. Identification of the CMR/ED substance used within the medical device, which must include definitions for both the functionality and performance provided by this substance as well as benefits the substance provides to the medical device.
  3. A risk assessment of the CMR/ED substance in the medical device. Potentially, this assessment could examine biocompatibility concerns, toxicological hazards, CMR/ED hazards, a determination of tolerable and/or acceptable patient exposures, and risks associated with intended uses and patient groups.
  4. Possible alternative substances, mixtures, designs and medical treatments.
  5. An assessment of potential relevant alternatives, including justification for their selection or exclusion as well as information on their availability.
  6. A description of the functionality and performance of these identified alternatives, as well as the benefits of their use.
  7. A risk assessment of each of these alternatives based on biocompatibility concerns, toxicological hazards, CMR/ED hazards, tolerable and/or acceptable patient exposures, and risks associated with intended use and patient groups.
  8. A comparison of the current CMR/ED substance’s functionality against the identified alternatives.
  9. A comparison of the current CMR/ED substance’s hazards against those of the identified alternatives.
  10. A benefit and risk assessment between the current substance and its potential alternatives.

Why Are These Guidelines Required?

The SCHEER guidelines were mandated under EU MDR 2017/745, section 10.4.3 (“Guidelines on phthalates”). These requirements place an added element of due diligence on medical device manufacturers using hazardous substances in their products. Regulators now want to see data-backed justification for continuing to use these substances in lieu of an alternative.

This new approach places additional responsibility on hazardous substance users to assess and report on potential alternatives. As part of the product approval renewals process, regulators are expected to further challenge companies to justify their use of these substances. Managing accurate, up-to-date data on the substances used in medical devices will be increasingly important to demonstrating due diligence in the future.

The Assent Compliance Platform helps companies streamline the collection of supply chain data to support a variety of risk mitigation activities. To learn more about Assent’s solution, email info@assentcompliance.com.

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