Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices

WG on Guidelines for BRA of Phthalates used in MDS
SCHEER members: Teresa Borges, Rodica Mariana Ion, Wim de Jong, Demosthenes Panagiotakos, Emanuela Testai, Theo Vermeire
SCCS members: Ulrike Bernauer, Christophe Rousselle
External experts: Stéphane Bégué, Hilde B. M. Kopperud, Maria Rosaria Milana, Tanja Schmidt
Experts from EU Agencies: Francesco Pignatti, Evgenia Stoyanova, Katarina Volk
Contact: SANTE-C2-SCHEERec [dot] europa [dot] eu (SANTE-C2-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 18 June 2019

Conclusions:

These Guidelines are intended to be used for a BRA of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. The Guidelines can be used for the justification of the use of CMR/ED phthalates in a medical device according to the Regulation (EU) 2017/745 on medical devices. They also provide a framework on how to assess and compare possible alternative substances, materials, designs or medical treatments to the use of CMR/ED phthalates in medical devices. Major aspects include the functionality of phthalates, the performance of the medical device using the phthalate or the potential relevant alternative for the phthalate, as well as the risk assessment of the phthalate or the alternatives. In the end, the benefit(s) shall be weighed against the possible risks of the use of the CMR/ED phthalate and of the alternative substance, materials, designs or medical treatments. This overall analysis will determine whether it is justified or not to use a CMR/ED phthalate in a medical device.

In view of the concern of the CMR/ED properties of phthalates, further research to possibilities to replace these phthalates in medical devices is highly encouraged by the SCHEER.

During the preparation of these Guidelines for BRA of the use of CMR/ED phthalates in medical devices, SCHEER noticed that a number of BRA methodologies are theoretically available. However, there is a considerable lack of data for the BRA for potential relevant alternatives to be used in medical devices. Therefore, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices. As the BRA of the presence of phthalates may have an impact on the conclusions of the "overall" benefit-risk determination of the medical device, a periodic update of the BRA of the medical device may be needed. The BRA of the presence of the CMR/ED phthalate should be updated when new scientific information becomes available on alternatives for the use of phthalates, when new Guidelines are released, or as the "overall" benefit-risk determination of the medical device is updated. A plan to perform an update of the general BRA for the medical device should be included in the dossier before marketing the device, and this should also include a plan regarding the necessary updates on the evaluation of alternatives for CMR/ED phthalates.

Pending on new scientific evidence, it is recommended to evaluate the use and usefulness of these Guidelines after an application period of three years.

Keywords:

Guidelines, benefit-risk assessment, CMR/ED phthalates, medical devices, SCHEER

Scientific Advice to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties, final version adopted at SCHEER plenary on 18 June 2019.