Impact of MDR 2017/745 on the use of intra-ocular lenses for cataract surgery

The purpose of the research is to determine if the implementation of EU MDR 2017/745 had any regulatory, clinical or market related impact(s) on the in vivo use of intra ocular lenses (IOLs), for cataract surgery on the European Market. Methods The investigation was conducted as a narrative literature review, drawing on both academic and grey literature. This review synthesised existing research pertaining to EU MDR 2017/745 and its impact on the use of intra-ocular lenses during cataract surgery and their long-term in vivo function. Discussion The key regulatory changes introduced by the EU MDR 2017/745 and their implications for intra-ocular lenses were evaluated through regulatory, clinical and market viewpoints. The classification of IOLs was determined as a Class IIb device within the European Union. We review how this classification impacts IOL regulatory requirements, such as clinical evaluation and post-market surveillance. From a clinical point of view, it was determined that such changes would impact clinical staff and the end user in a variety of ways including reduced lens choice, lengthened surgical wait times and higher device cost. The IOL market undulated since implementation of the MDR in 2017, notwithstanding other global shifting paradigms such as Brexit, the SARS-CoV-2 Pandemic, the Russian-Ukraine war and potential uncertainties in global trade policies and tariffs each playing a significant role post ratification of the MDR. Despite these challenges, the aging European population guarantees the demand for cataract surgery with it set to continue as the most performed surgical procedure in the world. ConclusionThe implementation of EU MDR 2017/745 has had several impacts on the use of IOLs for cataract surgery but the long-term impacts of MDR 2017/745 are currently unknown and time will tell whether the regulation is as effective as originally anticipated.