Risk of medical device shortages: blood bags
Question for written answer E-002133/2022
to the Commission
Nathalie Colin-Oesterlé (PPE), Anne Sander (PPE)
On World Blood Donor Day 2022 and against the backdrop of the upcoming proposal to revise Directive 2002/98/EC on the collection of blood products, which will focus on reducing European dependence with regard to such products, the European blood bag industry is on the brink of ruin.
Under Regulation (EC) No 1907/2006 (REACH), the industry is required to remove bis(2-ethylhexyl) phthalate (DEHP) from its products.
Following the entry into force of Regulation (EU) 2017/745 on medical devices in May 2021, the industry was also required to add an identifier to any old commercial products containing DEHP by May 2021 and must stop utilising it in new products by May 2024. An initial written question on the aforementioned regulation was submitted on 27 October 2021.
- 1.So as not to prevent the marketing of medical products, which would lead to dangerous shortages for patients, what action will the Commission take to make sure that the deadlines are met, despite the shortage of notified bodies?
- 2.Is the Commission planning to extend the transitional period for products placed on the market before May 2021 that already have European certification?