MedTech Europe in the headlines in September 2026
Posted on 06.10.2026
In September, MedTech Europe featured prominently in coverage of the MDR/IVDR revision, setting out its positions on the IVDR, single-use devices and AI-enabled medical devices. Coverage also centred heavily on the EU’s proposed Public Procurement Regulation, with MedTech Europe welcoming the shift towards value-based procurement while warning against “Made in Europe” requirements. Further coverage included the State of the Union address, the EU’s proposed PFAS restriction, and a new collaboration with Team-NB to digitise conformity assessment.
EU project will digitise conformity assessment to free up manufacturer resources
Medtech Insight reported that Team-NB and MedTech Europe joined forces on a project to digitise MDR and IVDR conformity assessment procedures, backed by €4m in funding, with the European Commission hoping the initiative will help promote a more innovative and competitive medtech industry.
FDA backs PFAS in medical devices as Europe moves to ban them and suppliers offer alternatives
As reported by Medtech Insight, FDA has reaffirmed that fluoropolymers like PTFE remain safe and irreplaceable in devices, but this US reprieve offers little shelter from an EU REACH restriction on track for 2027 adoption, one that MedTech Europe warns could still hit availability of endoprostheses, vascular grafts, cardiovascular patches, sutures, hernia mesh and endoscopes even with derogations in place.
Surgical robots deliver – but who pays?
Robotic-assisted surgery can improve patient outcomes, shorten recovery times and ease physical strain on surgeons while helping hospitals use their capacity more efficiently, policymakers said at a roundtable on the technologyʼs future. Yet, as Laura Hampunen of MedTech Europeʼs Robotic-Assisted Surgery Sector Committee told Euractiv, access and implementation remain uneven across Europe.
United States medical devices manufacturing
President Donald Trumpʼs second-term trade policies and global tariffs, multinational medical device companies have accelerated US manufacturing investment as a key strategy to negotiate tariff exemptions and mitigate supply chain risks. Business Online highlighted that medical devices remain subject to tariffs by the US despite calls from trade associations AdvaMed and MedTech Europe, which have warned continued tariffs on the sector will negatively impact patient care and healthcare system resilience in the US.
It’s Public Procurement Act day
As the Commission unveils its Public Procurement Act, alongside the Innovation Act, the medtech sector is warning that a proposal to prioritise ‘Made in Europe’ products in public tenders as part of the EU’s overhaul of its public procurement rules could hurt the price and accessibility of medical devices in Europe. ‘It really is a red flag for me personally,’ Oliver Bisazza, CEO of MedTech Europe, told Politico’s Morning Health Care. ‘We would rather Europe maintain its long-standing approach of open borders, open trade, free trade, and being the bastion of that in the world, rather than joining the same protectionist tendencies as so many other governments.’
Euractiv, Politico, and Regulatory Affairs Professionals Society (RAPS) further reported that EFPIA and MedTech Europe both welcomed the EU’s shift from price-based to quality-based procurement, but cautioned against strict localisation or ‘buy European’ requirements. MedTech Europe reiterated that origin-based rules could disrupt global supply chains, shrink the range of technologies eligible for tenders, and ultimately restrict patient access.
MedTech Europe pushes back against changes to single-use medical device rules
Under planned changes to the Medical Devices Regulation, manufacturers would need to justify why a single-use product cannot be reused. Regulatory Affairs Professionals Society (RAPS) quoted MedTech Europe’s pushback: ‘Reprocessing of single-use devices should not become a regulatory default.’ The association argued that a device’s intended purpose should stay with the manufacturer, consistent with the MDR’s existing requirements on clinical benefit, safety, performance, and the state of the art in medicine.
Industry fears fragmented AI medical device rules
MedTech Europe welcomed Parliament’s proposed medical device rule amendments but flagged fragmentation risks, as reported by Euractiv. Alexander Olbrechts, Director of Digital Health & Medtech Value, pointed to growing recognition among MEPs that AI-enabled medical devices need a single framework rather than ‘two parallel compliance systems.’ Yet he warned that removing delegated and implementing acts could leave the system ‘half-built,’ while abandoning the sectoral approach risked ‘duplicate assessments, legal uncertainty and delays for patients.’
MedTech Europe welcomes AI push in SOTEU, flags procurement gap
Euractiv reported that MedTech Europe welcomed von der Leyen’s AI-in-healthcare remarks, but pointed to the absence of public procurement reform. CEO Oliver Bisazza noted EU healthcare procurement is worth over €2.6tn annually and shouldn’t be driven by price alone, urging the Commission to ‘buy better, not just buy European.’ Politico further highlighted MedTech Europe’s reaction to the State of the Union (SOTEU) address, noting its agreement that ‘AI should empower doctors, not replace them’, while still pressing for coherent AI regulation to back investment in remote monitoring and diagnostics.
The European Commission is piling up projects to accelerate industrial AI even as existing efforts to drive the tech’s adoption remain a work in progress, following the announcement of AI initiatives across five sectors in November. Euractiv noted that Europe’s healthcare sector immediately picked up on this “strong overlap” after von der Leyen’s speech. The Commission should fulfil the promises in its original strategy, MedTech Europe told Euractiv.
In vitro devices get less attention in EU reform
Euractiv reported that the in vitro diagnostics component of the MDR/IVDR revision has received considerably less attention from EU lawmakers than its medical devices counterpart. MedTech Europe cautioned against complacency, noting that healthcare systems will increasingly rely on in vitro diagnostics as ageing populations and chronic diseases drive up testing volumes. The relative lack of attention is a missed opportunity to bring simplification to a sector whose results inform up to 70% of clinical decisions, and called for certain MDR amendments to be extended to the IVDR.
New EU Regulation Addresses Many, But Not All, Of Medtech’s Procurement Concerns
In an interview with Medtech Insight, Alexander Olbrechts, Director Digital Health and Medtech Value at MedTech Europe, welcomed the newly proposed EU Public Procurement Regulation, which aims to simplify procurement across the single market and put more weight on quality considerations. However, he raised concerns about how much weight quality will actually carry in contract awards, the lack of a common EU definition of quality, the risk of fragmentation across member states, and a “European preference” criterion that overlooks the full medtech value chain.