The ongoing trend of the pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. Among other risk factors, the safety of a drug product depends on the quality of the elastomeric components.

In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. While it is convenient to receive treatment at home without having to travel to a healthcare facility, the notion of administering drug injections, or even the sight of needles, can be intimidating to many individuals. The process can be greatly simplified with the use of auto-injectors. These devices typically contain a drug-filled syringe and make the injection procedure more straightforward by semi-automating the process.

During the 14 June 2022 Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Health Council concerns were raised regarding the challenges facing the implementation of Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) and the potential impact to the continued availability of certain medical devices on the EU market. Subsequently, at the 9 December 2022 EPSCO Health Council-¹, the European Health Commissioner, Stella Kyriakides, proposed an urgent, targeted legislative initiative to amend the transitional provisions provided for in Article 120 of the MDR².