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LISBON – Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical follow-up (PMCF) plan is realistic, according to experts who spoke at RAPS Euro Convergence 2026 on Thursday.

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MedTech Europe has shared feedback on planned changes to the European Union’s medical device and diagnostic regulations, offering high-level support for the revisions while calling for tweaks to aspects of the proposals.

Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), announced a new pilot program promising one-day inspections for low-risk facilities on Wednesday.

LISBON – A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU Medical Device Regulation (MDR) at the RAPS Euro Convergence 2026 conference on Wednesday.

The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

LISBON – Regulators will need to evolve as new technologies come to market, according to experts who spoke at the opening plenary session of RAPS Euro Convergence 2026. Major challenges include finding the right balance between safety and regulatory flexibility and determining an acceptable level of uncertainty.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

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The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for increasing access to treatments for ultra-rare diseases yet raised questions concerning various aspects of the program.

COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product software, two panelists recently told attendees, at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three-month pilot.