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Comprehensive Update on the Guidelines for Benefit-Risk Assessment of CMR/ED Phthalates in Medical Devices

Medical devices regulation

The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has released a significant update to its guidelines concerning the benefit-risk assessment (BRA) of phthalates used in medical devices. These phthalates are identified as Carcinogenic, Mutagenic, or Toxic to Reproduction (CMR), or possess Endocrine-Disrupting (ED) properties. This update revises the 2019 guidelines based on new scientific data and practical feedback from stakeholders in the medical device industry

Key Updates and Enhancements:

1. Scope and Introduction:

  • Expanded Scope: The updated guidelines now provide more comprehensive information on their intended use, extending beyond the initial scope to cover additional regulatory contexts and applications.
  • Chemical Descriptions and Regulatory Developments: Enhanced descriptions of the chemical nature of phthalates, particularly as esters of phthalic acid, and updates on recent regulatory changes affecting their use.

2. Enhanced Methodologies:

  • Evidence and Weight of Evidence (WoE) Approach: Introduction of a section detailing the sources of evidence used and the application of the WoE approach, which aggregates data from various studies to form a comprehensive risk assessment.

3. Framework Adjustments:

  • Terminology Refinements: The terminology within the framework has been refined from “potential relevant” to “most relevant” candidates when evaluating alternatives to CMR/ED phthalates. This aims to streamline the assessment process by focusing on the most promising alternatives.
  • Evaluation Requirements: A minimum of three alternatives must be evaluated unless fewer can be justified with additional information. This change aims to ensure thorough evaluation while avoiding unnecessary extensive assessments.

4. Regulatory and Annex Updates:

  • ED Hazard Classification: New information on the regulation regarding ED hazard classification, with categories for known or presumed endocrine disruptors and suspected endocrine disruptors.
  • Additional Annexes: Three new annexes provide detailed information on exposure to current CMR/ED phthalate alternatives (Annex 8), health hazards associated with these alternatives (Annex 9), and recent progress in developing alternatives for use in blood bags (Annex 10).

Detailed Framework and Methodology:

1. Assessment Steps for CMR/ED Phthalates:

  • Step 1: Description and characterisation of the medical device composition, including identification and concentration of CMR/ED phthalates.
  • Step 2: Description of the use and function of CMR/ED phthalates within the device, detailing their critical role in device performance and patient benefits.
  • Step 3: Risk assessment of CMR/ED phthalates, including patient exposure estimation and toxicological risk characterization.

2. Evaluation of Alternatives:

  • Step 4: Inventory of possible alternatives, including substances, materials, designs, and medical treatments.
  • Step 5: Identification of the most relevant alternatives, with justification for their selection.
  • Step 6: Detailed description of the functionality, performance, and benefits of the most relevant alternatives.
  • Step 7: Risk assessment for the most relevant alternatives, focusing on patient exposure and toxicological risks.

3. Comparison and Justification:

  • Step 8: Comparison of functionality and performance between CMR/ED phthalates and the most relevant alternatives.
  • Step 9: Hazard characterization and exposure comparison.
  • Step 10: Overall benefit-risk comparison to justify the use of CMR/ED phthalates.

Importance for Various Stakeholders:

  • Manufacturers: Must rigorously perform BRAs, ensuring comprehensive data collection and analysis to justify the use of CMR/ED phthalates or to identify suitable alternatives.
  • Regulatory Bodies: Utilize these updated guidelines to assess the safety of medical devices and enforce compliance with the latest regulatory standards.
  • Healthcare Providers: Ensure that medical devices in use meet the highest safety standards, thereby safeguarding patient health.


The updated SCHEER guidelines provide an essential framework for assessing the benefit-risk ratio of CMR/ED phthalates in medical devices. This update emphasizes the importance of high-quality data, thorough evaluation of alternatives, and continuous revision based on the latest scientific evidence. These guidelines aim to enhance patient safety and ensure the efficacy of medical devices in the healthcare industry.

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European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety

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