Commissioner Olivér Várhelyi has clarified the European Commission's stance on Lyme disease testing oversight, confirming existing regulatory controls but ruling out new EU-wide patient registries or expanded evaluation powers. The response, addressing a parliamentary question from Renew MEP Cynthia Ní Mhurchú, details progress on three suggestions from a petition by John Vandeput for EuroLyme: a working group, best practice exchange, and an infected-patient databank, along with oversight of Borrelia blood tests and evaluation of new testing methods.
Várhelyi’s reply cites actions involving the European Centre for Disease Prevention and Control (ECDC) and an EU Reference Laboratory but notes no plans for a patient registry. He confirmed existing regulatory controls under Regulation (EU) 2017/746 for Borrelia tests but highlighted the lack of a mandate for EU-wide medical device evaluations. This follows the Commission's broader health package announced on March 16-17, 2026, where Várhelyi proposed simplifying medical device regulations, including fixed timeframes for conformity assessments and expanding the list of well-established devices exempt from complex certification. That package also included the Biotech Act, aiming to shorten clinical trial approvals, and the Safe Hearts Plan.
Earlier, on April 14, 2026, Commissioner Ursula von der Leyen pushed to resolve medical device delays, promising legislative and procedural reforms to balance safety with quicker market access. That response to a parliamentary question from MEP Ní Mhurchú outlined a December 2025 legislative proposal for MDR revision, an April 2026 Implementing Regulation setting maximum timelines for notified body certifications, and March 2026 Delegated Regulations easing requirements for well-established technologies. The same day, Renew MEP Vlad Vasile-Voiculescu and EPP’s Adam Jarubas clashed over the EU Cancer Plan’s focus on measurable outcomes during a SANT committee meeting, which also addressed the MDR/IVDR revision.
Várhelyi’s latest reply emphasizes reliance on existing EU networks and national health technology assessments rather than creating new registries or expanding EU evaluation powers. Borrelia tests come under an established independent oversight scheme, and the Commission avoids deepening EU intervention or creating additional centralized institutions. Medical device manufacturers benefit from existing certification regimes that balance oversight with market access, while patients and healthcare providers may find the absence of a unified EU patient databank and evaluation a missed opportunity for harmonized standards and improved diagnostics. EU public health authorities maintain cooperative roles without extra mandates, and the Commission limits administrative burdens but potentially at the cost of slower access to novel testing assessments.
This reply provides key signals on the Commission's cautious approach, reiterating the commitment made on April 14 to leverage current frameworks. Commission responses to petitions are typically stepping stones, and follow-up actions by EU bodies, notably ECDC and national agencies, will be pivotal. The absence of new concrete tools suggests ongoing monitoring rather than immediate policy overhaul, setting expectations for stakeholders about gradual evolution rather than rapid reform.
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