Regulatory
The key point for manufacturers who have cleared the MDR process is that they must pay attention to providing data continuously because a shift is on the way.
meet the posture shift being proposed. Beyond shifting data obligations, Mathangi Srinivasan, a quality assurance manager in the medical device industry, highlights a lack of guidance on what evidence standards will satisfy the changes the EC is proposing. “A single device can have multiple expectations, depending on which notified body reviews it,” she notes, “and that inconsistency is going to make it difficult for manufacturers.” Meanwhile, Srinivasan’s broader issue with the
EC’s proposal is that while it would simplify certain requirements for manufacturers, it is unlikely to be implemented until late 2026/early 2027. “And the final text is probably going to look different from what is being proposed,” she notes. “It’s a compliance plan built on a target that’s moving; and it therefore becomes a shift we can currently only predict the outcome of.”
7,000 Dr Royth von Hahn 18
TÜV SÜD performed thousands of technical assessments for different medical products under the EU Medical Device Regulation (MDR) in recent years.
Key concerns for notified bodies To streamline manufacturers’ obligations under the MDR, the EC’s proposal, which Hahn anticipates will be finalised by the end of 2026, would also “change how notified bodies are supposed to work” – a factor TÜV SÜD holds “significant concerns” around. Much of what the EC is addressing with the proposal surrounds the work of notified bodies, Hahn says, rather than what manufacturers have to provide. “What we would be doing [under the proposal] is no longer looking at certain deficiencies or violations of the MDR, and with this we are cutting costs by basically not identifying those. But just because we are no longer looking at it, this doesn’t mean the products are in conformance,” Hahn explains. To illustrate his point, Hahn shares that TÜV SÜD performed more than 7,000 technical assessments on different medical products under the MDR in recent years. Single deficiencies throughout this endeavour
totalled more than 60,000, with around a third being administrative and two thirds technical, Hahn says. “They don’t mean a product is necessarily unsafe, but that certain technical aspects provided by a manufacturer are not in line with the MDR requirements. “Now, we are, in effect, being required to cut costs by no longer looking at certain deficiencies. We would be reducing sampling, technical document assessment on well-established technologies, and so on.” In essence, this shift means that notified bodies would have to reduce their number of findings, in turn reducing the potential follow-up work manufacturers would have to do, not by changing the MDR’s underlying requirements, but “basically by no longer looking at them”, Hahn explains. With this streamlined approach, the risk TÜV SÜD foresees is that if something happens with a product on the market, there would be “no evidence that the manufacturer did everything according to the rules, which becomes a problem in case of a safety- related incident.”
While the EC may counter that other surveillance measures, such as unannounced audits, remain in place to ensure issues like this do not occur, such measures are under the label of ‘for cause’.
Hahn says: “For cause means we do a reduced surveillance, sampling and assessment at the beginning, and then we are basically waiting until something happens, and that’s a paradigm change from a preventive approach, saying that we want to know in the beginning whether the manufacturer is really capable of complying with all these rules.” The effect of the EC’s proposal on notified bodies notwithstanding, the expectations for manufacturers are evolving, Geraldes says, and whatever efforts and systems manufacturers have made to produce audit-ready documentation “will have to change going forward”. ●
www.medicaldevice-developments.com
Sergii Gnatiuk/
Shutterstock.com
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