Top Ten August: Perceived Failures Linked To MDR/IVDR Implementation Result In Fresh Calls To Action
Executive Summary
It is no secret that that the implementation of the EU’s Medical Device and IVD Regulations has been problematic. Now, despite most processes and documents being in place, experts are making fresh warnings and calling for radical changes.
Two key documents released in August, a white paper from German industry associations VDGH and BVMed proposing fundamental changes in the regulation of medical devices, and a position paper from TEAM-NB calling for urgent stakeholder action, provided some critical food for thought over the traditional European holiday month.
The white paper, written in collaboration with expert medtech regulatory lawyer and founding partner at Axon Lawyers, Erik Vollebregt, focuses on the current damage to innovation caused by the implementation of the Medical Device and IVD Regulations. In particular, it includes a proposal to have a centralized governance agency modeled on the European Medicines Agency, but specifically for devices.
The authors argue that this could be the answer to what many consider to be a fundamental failure of the implementation of the MDR and IVDR.
But the proposal is dividing opinions. Some see it as a practical way out of the current challenges in the implementation, while others think it would take much too long to set up. Sabina Hoekstra-van den Bosch, global director regulatory strategy at the notified body TÜV SÜD, said it is far too early to conclude that the medtech sector needs a central body. She noted noting that the European Commission has already instigated a Study on Regulatory Governance and Innovation in the field of Medical Devices in the framework of EU for Health and that the outcomes of this should be awaited first.
In addition to the white paper released by the German associations, the notified body association, TEAM-NB, issued a position paper where it warned manufacturers delaying their MDR transition could disrupt notified body planning and upend the whole sector’s efforts to achieve the extended timelines now in place for legacy products.
The association is concerned that manufacturers have responded to the extended timelines by deprioritizing their applications, and believes that too little is being done to reduce the weight of administrative tasks falling to notified bodies.
This threatens the very infrastructure in which notified bodies have heavily invested to manage the workload in a timely and effective manner, including through hiring additional staff, TEAM-NB said.
More EU News
In other EU news, the commission has published a practical document to help manufacturers and other relevant medtech sector actors decide whether a device can benefit from the extended transitional periods brought in under the recent amending regulation to MDR, and under what conditions.
Also, a latest progress report indicates that a new notified body is due to be designated under the IVDR. Its appointment will bring the total under that Regulation to 11, while there are 39 designated under the MDR.
In addition, there has been some good news for manufacturers of IVD products who have a short reprieve – until the end of the year − when it comes to using lead as a thermal stabilizer in polyvinyl chloride (PVC) sensors. The decision has been made in the context of the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive because there has not yet been adequate substitution of lead in specific sensors.
And, in the area of health data. progress has been also made towards the development of what could become the first pan-European platform for facilitating access to and analysis of diverse types of digital health data for regulatory and health technology assessment (HTA) decision making. Technical teams have now laid the cornerstone for the platform, and the initial focus will be lung cancer.
Listen To Some Of Our Latest Insights
Two Medtech Insight podcasts were published during August: the first explores the regulatory differences between EU and US regulations for digital health products and looks at cybersecurity legislation, reimbursement of digital health products, and current AI regulations; the second looks at progress to date in the development of the European medical device database, Eudamed, designed to support the implementation of the MDR and IVDR, at what companies need to know now and how actors should be preparing.
Swiss News
In Switzerland, meanwhile, Swissmedic, the national healthcare products regulator, confirmed in August that part of the swissdamed database, an initiative designed to mirror the EU’s Eudamed, will go live on a voluntary basis in January 2024. The first part to go live from that date will be Module 1 (Modul ACT) on the registration of companies and economic actors. The future Swiss UDI and product identification database, under Module 2 (Modul UDI), will be ready in summer 2024.
Also on the topic of Swiss medtech regulations, co-founder of Lausanne-based Abionic SA, Iwan Märki, spelt out for Medtech Insight how the MDR and IVDR are negatively impacting the ability of start-ups to access the EU market while, by contrast, the US is being seen as a more compelling launch market for EU and Swiss innovators alike. He is calling on the EU to address the topic of innovation, a topic that was at the fore of the white paper published by BVMed and VDGH, cited above.
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For a summary of the previous month’s news, see: EU Regulatory Roundup, July 2023: Weighing Up The Impact Of The MDR Amending Regulation