Independent scientific committee SCHEER published the final Guidelines on the benefit-risk assessment of the presence in certain medical devices of phthalates, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).
These Guidelines can be used by manufacturers, notified bodies and regulatory bodies for the justification of the use of CMR/ED phthalates above a concentration of 0.1% w/w in a medical device – as regulated by the EU MDR (Annex I section 10.4.1.).
In 40 pages, the document presents the framework for benefit-risk assessment (BRA), assessment of possible alternatives, justification for the use of CMR/ED phthalate, benefit assessment (material, clinical benefits), methodologies for benefit-risk assessment, uncertainty analysis and conclusions.
In its conclusions, the SCHEER notes that 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; the Committee also notes that number of BRA methodologies are theoretically available, nevertheless 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.
Finally, on the process, it was initiated by a request of the European Commission, followed by a short period of public consultation (18.3.-29.4.) as announced in our Library of documents – Public consultations.