Will the MDR transition fall short of mitigating impact on IR and beyond?

Profile: Theresa Caridi page 16

In May 2021, the European Union (EU) Medical Devices Regulation (MDR) came into force to revise quality and safety standards for thousands of types of medical devices, and to reclassify in some cases. MDR was intended to come into effect in May 2020 after a three-year transition period, but this was delayed due to the COVID-19 pandemic. The transition period was recently extended again to allow device companies and manufacturers more time to plan their route to conformity with the new regulations, which many industry and healthcare stakeholders consider will make for slower implementation of new devices than under the MDR’s precursor, the Medical Device Directive (MDD). Interventional News sought out the views of interventional radiologists in Europe and the UK to capture the concerns within the sub-specialty relating to MDR, as well as those of industry.

In March 2023, European Council members voted to give producers of higher-risk medical devices until 31 December 2027, and those of mediumand lower-risk devices until 31 December 2028, to bring their products in line with the new rules on safety and quality. This gives manufacturers at least three years and six months’ extra time to adapt, as the conformity deadline initially adopted when MDR came into force was May 2024.

In December 2022, ahead of the March extension vote, EU health commissioner Stella Kyriakides was quoted explaining, in a European Council meeting, the rationale for going ahead with the vote. “We are […] experiencing [device] supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.” Her words echo the reasoning stated in the regulation, published in the Official Journal of the European Union following the March vote: “In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of [MDD] certificates.”

Philippe Pereira

Legislative measures taken with mitigation in mind, in Switzerland

With a more regulated device landscape on the horizon, the Swiss Parliament voted to allow US Food and Drug Administration (FDA)-approved devices onto the market in Switzerland, in November 2022. Swiss Medtech were among the backers of this decision and shared in a press release from the time of the vote that “more than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products—they are not prepared to meet the additional requirements for the limited Swiss market, and patients in Switzerland are the ones to suffer”. This statement summarises the challenges that many companies, health professionals, and others involved in the provision of healthcare by means of medical devices face now, with the MDR transition period already in motion.

Examining IR opinion

Philippe Pereira, an interventional radiologist and director of the Center for Radiology at SLK-Kliniken (Heilbronn, Germany), co-authored an editorial in December 2022 which looks ahead to the obstacles MDR will create for interventional radiologists as the transition period ends and nonconforming devices are taken off the market.

Published in CardioVascular Interventional Radiology, the article warns that “taking devices with small profit margins, including orphan devices or devices for niche indications, such as those for many paediatric IR procedures, off the market instead of going through a costly and still uncertain rectification process has become an option.” The authors make the further point that this will increase the cost of devices that are recertified under MDR and put pressure on those manufacturers of surviving devices to increase their output. Should companies choose to apply for a recertification, Pereira et al set out their concern that “estimates of 13–18-month periods for the recertification could create a situation of safe devices becoming stuck in limbo between MDD certificate expiry and recertification, unavailable to patients and caregivers.” In their conclusion, the authors urge all

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In March 2023, the European Council voted to extend the MDR transition

FEW ADVERSE EVENTS ARE connected to the use of inferior vena cava (IVC) filters when they are used to help prevent deep vein blood clots from developing into pulmonary embolisms (PE), according to the findings of the Predicting the safety and effectiveness of inferior vena cava filters (PRESERVE) trial, published jointly in the Journal of Vascular and Interventional Radiology (JVIR) and the Journal of Vascular Surgery Venous and Lymphatics (JVS-VL). The study and its findings have garnered attention, to the tune of presentations and discussions at some of the largest recent vascular and interventional radiology meetings.

PRESERVE is a multicentre, prospective, open-label, nonrandomised trial that studied the safety and efficacy of IVC filters from six manufacturers. It was a joint effort of the Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS), carried out in cooperation with the US Food and Drug Administration. PRESERVE was sponsored by the Inferior Vena Cava Filter Study Group Foundation—a foundation created by SIR and SVS to receive and distribute funds supplied by manufacturers to the contract research organisation and sites. The study was conducted at 54 sites in the USA between 10 October 2015 and 31 March 2019. During that time, filters were implanted in 1,421 patients, of whom 1,019 patients had an existing deep vein thrombosis (DVT) or pulmonary embolism (PE). Trial results suggest that IVC filters were effective in helping to prevent PEs in patients experiencing a DVT. Approximately half of the patients in the study had their filters removed within three months of placement, and only one of 23 incidences of PE occurred within the 30-day post-filter removal observation period, according to study authors.

“The question should not be only ‘should we place a filter?’ but ‘how should we offer comprehensive filterinclusive care of patients with venous blood clots, comprised of a detailed patient evaluation, a plan for retrieval after placement, and frequent followup with evaluation for filter removal or replacement,’” said Matthew S

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