Published 01 August 2022
Manufacturers must ensure that all medical devices are certified as compliant with EU regulations introduced in 2017 and active from May 2024; however, assessment of certification applications is presently taking ‘13-18 months’, which risks leaving many products non-compliant for the European market.
IVF clinics and their laboratories have been warned that from 26 May 2024 many ‘medical devices’ used in their everyday procedures risk being temporarily or terminally unavailable. The May date is the deadline by which all device manufacturers must ensure that their products are fully compliant with EU regulations introduced in 2017 and applicable from May 2021 to ‘establish a robust, transparent, predictable and sustainable regulatory framework for medical devices’.(1) These regulations (MDR) make it clear that medical devices not certified as compliant by May 2024 will have no access to the EU market.
According to data reported by the EU’s Medical Device Coordination Group, 90% of currently available medical device conformity certificates will expire during 2023-2024, and, from 27 May 2024, manufacturers are responsible for ensuring that their devices comply with the new MDR.(2) Worryingly, the same report noted that in December 2021 37% of manufacturers’ submissions for new certification had been refused ‘on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness’. In April 2022, the report adds, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete. The Biomedical Alliance, of which ESHRE is a member, reported in a recent press release that MDR conformity certificates had so far been granted to only 1069 devices from a total of around 25,000 thought applicable.(3)
The EU emphasises that the MDR are fully applicable to all devices, and, in short reference to ART, include ‘devices for the control or support of conception’ - to presumably cover all everyday equipment in an IVF clinic and lab, from consumables and basic labware to transfer catheters to incubators and even to vitrification systems. But, says Swedish embryologist Aisling Ahlström, an ExCo member who now leads a new ESHRE working group set up to monitor MDR progress, we have yet to ‘clarify the broad MDR definition of medical devices in the context of assisted reproduction’. The working group’s aim, says Ahlström, is to monitor the implementation of the MDR and how it will affect ART and clinics, and to provide expert opinion to the EU and national regulators on what products and equipment are considered ‘critical’ (as defined by the original Tissue and Cell Directives) and should have MDR certification (CE marking) when used in ART.
But what is currently worrying the group – and indeed clinics – is the risk that many of these devices may simply disappear from the market, removed by manufacturers unable, or unwilling, to secure MDR certification for their European markets. ‘A hidden number of devices may be taken off the market,’ Ahlström told Focus on Reproduction, ‘either for an unknown period of time or permanently, as manufacturers struggle to obtain MDR certification or weigh up its costs against the profitability of each device. In addition, the launch of many innovations may not prioritise Europe because of the stricter components of the regulations and postmarket surveillance requirements. We have already heard that manufacturers anticipate difficulties in delivery of products if time problems in processing MDR applications are not resolved.’ A meeting of MedTech Europe, representing manufacturers, reported in May that MDR certification was taking ’13-18 months on average’.
In its press release the Biomedical Alliance similarly seemed to attribute the risk of product non-availability to the regulators and EU, which had ’never allocated’ the personnel or resources deemed necessary ‘to deliver the requirements of the new regulation’, while ‘the capacity of the notified bodies to approve devices remains insufficient’. ‘Special measures’ are urgently needed to avoid a ‘major clinical crisis’, said the Alliance.
However, the Alliance – and ESHRE – makes no complaint against the requirements of the MDR, which are in place, and have been since 2017, to improve the evidence base of all devices and thereby patient safety. What’s causing contention is the time needed by manufacturers to make their certification submission, and by the notified bodies – presently some 30 in number – to review the files and grant the certificate. The questions now on the agenda are how to speed up both processes and avoid a product discontinuation – or the need for clinics to stockpile.
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