Overview of the Portuguese MedTech market, including regulatory requirements, market access pathways, and opportunities for manufacturers entering Portugal.

Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.

EU Parliament adopts AI Act simplification package. Key changes impact high-risk AI timelines, MDR alignment, and compliance requirements.

Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).

FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.

Team-NB releases a position paper defining how manufacturers can transfer notified body surveillance for legacy devices under MDR Article 120, including key requirements, timelines, and responsibilities.

The EU Cyber Resilience Act is reshaping GMP expectations for laboratories. Learn how cybersecurity, data integrity, and validation requirements will impact manufacturers.

MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.

EU expert panel highlights clinical evidence gaps, benefit-risk concerns and PMCF weaknesses for bioabsorbable orthopaedic screws under MDR.

Swissmedic updates guidance on systems and procedure packs. Key obligations, CH-REP requirements, and impact for medical device manufacturers.

The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.

FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.

MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.

Discover the latest European Commission update on ERNs and what their expansion means for medical device manufacturers in rare disease areas.

FDA releases updated guidance on pyrogen and endotoxin testing. Key clarifications for medical device and pharma manufacturers.

The FDA has issued final guidance on medical devices with indications associated with weight loss, outlining regulatory expectations for clinical studies, non-clinical testing, and benefit-risk evaluation.

Swissmedic has released Version 20.0 of its “Formal Requirements” guidance, effective 1 March 2026. Learn what pharmaceutical manufacturers need to know about submission formats, documentation requirements and parallel import updates.

Swissmedic has published version 3.0 of the swissdamed UDI Data Dictionary, introducing clarifications to SRN fields and new machine-to-machine attributes for improved data mapping.

Team-NB warns that proposed MDR and IVDR revisions could reduce regulatory scrutiny and create unintended consequences for EU manufacturers, despite improvements in digitalisation and innovation pathways.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.