MedTech Europe in the headlines in October 2026

MedTech Europe in the headlines in October 2026

Posted on 01.10.2026

October media coverage highlighted MedTech Europe's call for a single regulatory pathway for AI-enabled medical technologies, efforts to reduce regulatory duplication and accelerate patient access to innovation, as well as its support for a shift towards value-based public procurement that prioritises quality alongside cost. The publication of the Facts & Figures 2026 report also generated broad media coverage, drawing attention to Europe's slowing medtech growth and competitiveness challenges despite continued strengths in innovation, employment, and patent activity.

Europe must 'course-correct' medtech rules, industry warns

Speaking at the MedTech Conference in Boston, CEO Oliver Bisazza told Rapporteur that revising the MDR and IVDR is critical to Europe's competitiveness. 'Course-correcting the EU medtech rulebook is one of the most important things Europe can do to restore lost ground in an increasingly competitive world,' he said, adding that 'the world is watching how Europe handles this.'

As reported by Business Monitor Online, MedTech Europe welcomed the Commission's proposed MDR/IVDR reforms as necessary to address certification bottlenecks, device shortages and mounting pressure on SMEs, with particular support for measures to streamline certification, reduce regulatory burden and introduce dedicated pathways for breakthrough and orphan devices. Greater clarity on clinical evidence requirements will, however, be needed to avoid continued delays and uncertainty.

Industry calls for a single regulatory pathway for AI-enabled medical devices

As reported by Borncity, IlFarmacista, El Global Farma, diariofarma, and Sanità Informazione, MedTech Europe, EFPIA, COCIR, DIGITALEUROPE, ESTRO and EUCOPE published a joint statement, urging the EU to integrate AI Act requirements directly into the MDR and IVDR. The coalition warned that overlapping rules are lengthening certification timelines, contributing to shortages and delaying patient access. MedTech Europe and other associations urged the EU to integrate AI Act requirements directly into the MDR and IVDR, warning that overlapping rules are lengthening certification timelines, contributing to shortages and delaying patient access, as reported by Borncity, IlFarmacista and El Global Farma.

Following MEP Guzenina's withdrawal as S&D rapporteur for the IMCO opinion over a dispute on how to address AI requirements, MedTech Europe told Rapporteur it trusts Parliament to find a way forward, warning that 'two parallel regulatory systems with overlapping requirements' would ultimately delay patients' access to innovation.

The Digital Omnibus: Recalibrating Compliance for Agentic AI

Forkast News highlighted a March 2026 joint statement by MedTech Europe and more than 40 other associations calling for a delay to key AI Act requirements, which the EU has since agreed to. MedTech Europe argued the extension gives technical standards time to mature and companies time to prepare.

MedTech Europe "Facts & Figures 2026" Report

MedTech Insight, POLITICO, Rapporteur, Contexte, Notiziario Chimico Farmaceutico (NCF) and Nelson Advisors (Healthcare Digital) highlighted findings from MedTech Europe's Facts & Figures 2026 report showing that the European medtech sector remains strong in innovation, employment, and patent activity, but faces growing competitiveness challenges as market growth slowed to 1.8%, Europe's global market share fell to 25.6%, and the number of medtech companies declined for the first time on record. Coverage also underscored MedTech Europe's warning that regulatory complexity and slower uptake of innovation are weighing on the sector, while ongoing MDR/IVDR reforms are seen as a key opportunity to restore growth and investment.

Public Procurement Regulation: Shift Away from "Lowest-Price" Buying

As covered by Nelson Advisors (Healthcare Digital), MedTech Europe welcomed the shift towards best price-quality ratio and value-based procurement, while pushing back against European preference quotas that could disrupt medical device supply chains.

EU Aligns Safety Reporting For Combined Drug-IVD/Device Studies, But Double Reporting Persists

As reported by Medtech Insight, MedTech Europe welcomed the new COMBINE guidance in a social media post, while calling for the remaining duplicate reporting requirements to be addressed.