Ludger MöllerPhoto courtesy of Ludger Möller
The implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) has been, as the expert puts it, ‘a very rocky road’ – and the regulatory community is bracing for the next wave of complexity. Möller, Chair of the EAAR and head of Hannover, Germany-based MDSS GmbH, one of the EU’s leading authorised representative services, is closer to the regulatory turbulence of recent years than most. With parliamentary committees actively working through the reform proposals and a 2027 target timeline beginning to take shape, he believes the meeting in September is timed perfectly to take stock of where EU medical device regulation stands, and where it must go next.
The ongoing regulatory friction increasingly comes with a human cost, Möller finds: ‘We lose clients because of the MDR/IVDR,’ he says. ‘Small and medium-sized manufacturers simply cut off Europe – they are leaving. And very good medical devices are not available for European patients any longer.’ The consequence, he argues, is a reduction in clinical choice and competitive pressure that ultimately serves no one. The European Commission has, in his view, done extensive work to substantiate these concerns, and its findings underpin much of the current reform agenda.
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Relieving the regulatory burden
Central to his critique is the disproportionate clinical data burden placed on well-established and low-risk products. An engineer by background, Möller provides a telling example: the safety requirements of EN IEC 60601 are universally accepted as a harmonised standard – no one demands a clinical study to validate for example the leakage current. Yet under the MDR, manufacturers of long-established devices find themselves repeating the same clinical data exercises as their competitors, for products whose safety record is not in question. ‘Everyone knows the product works,’ he says. ‘It’s a legacy product, for many, many years on the market.’ He therefore points to the underutilisation of common specifications as a missed opportunity: standardised data requirements for lower-risk product categories could reduce both the administrative burden and the inconsistency between notified bodies.
The case for treating such products differently is, in his view, already being made by the market itself. Since 2021 – now more than five years ago – legacy devices have remained on the market without significant changes to their design and intended purpose. In that time, they have been subject to the rigorous post-market surveillance requirements of the MDR, to stricter market surveillance by the competent authorities, and, since May 2024, to the full QMS requirements, with notified body audits to match. ‘If those devices were not safe,’ Möller says, ‘it probably would have been noted by now.’
As a meaningful step to avoid this kind of over-testing, Möller welcomes the forthcoming regulatory definition of Well-Established Technology (WET): once a notified body has determined that a product qualifies as WET, he argues, that determination should be placed on a publicly available list – so that other notified bodies can scrutinize it in the same manner.
IVDR: an even steeper climb
If the MDR transition has been difficult so far, Möller predicts that the IVDR is bound to be cause for even more serious headaches. Under the former In-vitro Diagnostic Directive (IVDD), a high number of IVD products were not monitored by a notified body at all. The leap to the full rigour of the IVDR, he says, will be ‘a very difficult road to take, particularly for small and medium-sized manufacturers’.
This is where the role of the authorised representative becomes especially significant, the expert points out. For manufacturers outside the EU without a local subsidiary, the AR is often the first point of contact and the primary guide through the regulatory landscape, with the goal of obtaining the CE marking for their products. The simplifications proposed in the current reform package are, for Möller, not merely welcome – they are needed for the continued availability of IVD products on the EU market.
AI – the next regulatory frontier
Beyond the MDR and IVDR, a more fundamental challenge is taking shape: the advent of artificial intelligence (AI) presents a further layer of regulatory complexity – at a much faster pace than any framework can easily accommodate, Möller says. Medical devices already qualify as high-risk AI under the EU AI Act – a classification that, without careful alignment between the two frameworks, risks burying smaller manufacturers and university spin-outs under a double layer of regulatory obligations.
Every medical device comes with a risk. Even a scalpel can be used to cut the wrong way – yet without it, surgery is impossible
Ludger Möller
To avoid this, the expert endorses a framework called “the least burdensome approach” – borrowed from regulatory thinking in the US: Patient safety and product efficacy are non-negotiable, he stresses – but neither is product availability. He points to Germany’s digital health application reimbursement scheme (DiGA) as an example of the direction of travel, with AI-powered software applications increasingly entering routine clinical use. The concept of regulatory sandboxes – controlled environments in which products can be tested before full market entry – is one he finds particularly promising, and one he hopes will feature in the summit’s discussions.
Möller also points out a workforce dimension that is easy to overlook: the regulatory profession itself will need to evolve, drawing in people with backgrounds in data science, software engineering, and machine learning alongside the traditional mix of engineers and life scientists
A point of orientation in a shifting environment
This push for simplification, Möller emphasises, is not a retreat from safety: ‘Every medical device comes with a risk,’ he says. ‘Even a scalpel can be used to cut the wrong way – yet without it, surgery is impossible. We should be mindful of that.’ The goal, he argues, is not deregulation but calibration – ensuring that the regulatory framework serves patients by keeping safe and effective products available in the EU, not by excluding them.
The medical device sector is navigating a period of profound and rapid change – and the need for shared orientation has rarely been greater. For the EAAR, the September summit is designed to meet precisely that need: a forum where notified bodies, regulators, competent authorities, and manufacturers can take stock together. ‘A great meeting point to get a great update and outlook for the future,’ as Möller puts it – and, at this particular juncture, a point of reference for an entire industry.
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