Swissmedic has updated the swissdamed Actors User Guide (v2.0), introducing AGOV login migration updates, mandate transfer functionality, and clarified actor management requirements for medical device manufacturers and authorised representatives in Switzerland.

The European Commission has updated the MIR 7.3.1 vigilance reporting forms under the EU MDR and IVDR. Manufacturers should verify accepted versions and updated XSD/XSL files.

The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.

TEAM-NB releases Code of Conduct v5.2 for MDR/IVDR Notified Bodies. Discover key changes and how they impact medical device manufacturers.

FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.

Swissmedic releases updated guidance on medical device software (MDSW), covering qualification, classification, and regulatory requirements under MDR/IVDR.

Learn about EU Batteries Regulation (EU) 2023/1542, including key requirements, scope, and timeline. What manufacturers need to know for compliance from 2025 onwards.

EU Delegated Regulation 2026/881 defines when cybersecurity vulnerability and incident notifications may be delayed under the Cyber Resilience Act.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

The EDPB publishes a new 2026 DPIA template to standardise GDPR compliance. What it means for medical device manufacturers.

Notified bodies highlight key risks and proposals in the EU MDR/IVDR targeted revision, including clinical evidence, WET, and regulatory oversight.

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

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

Swissmedic publishes updated EUDAMED UDI enumerations (v2.18.0). What this means for manufacturers preparing UDI, device and certificate data submissions.

New EU-U.S. Data Privacy Framework FAQ impacts data transfers to U.S. vendors. What this means for medical device manufacturers in 2026.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.

The FDA has issued a new draft guidance that updates the scientific principles for demonstrating biosimilarity. The document clarifies when strong analytical similarity data, supported by comparative human pharmacokinetic and immunogenicity assessments, may be sufficient to demonstrate biosimilarity without requiring a comparative clinical efficacy study. This updated approach can help manufacturers reduce development timelines and costs, while placing greater emphasis on robust analytical packages, sensitive PK study designs and a clear, risk-based justification aligned with FDA expectations.

The new revised version of the MDCG 2019-11 (Rev.1) clarifies the qualification and classification of software as a medical device (MDSW ) and in vitro diagnostic software (IVD), in the context of the MDR and IVDR. The document covers classification rules, integration with AI Act and EHDS, and includes practical and up-to-date examples. Smart MDR supports MDSW manufacturers in managing compliance and technical documentation.

The MHRA has published a new Periodic Safety Update Report (PSUR) template for medical devices in the UK, in line with the UK MDR. The document details how manufacturers should structure their post-market monitoring (PMS) reports, including performance data, surveillance, PMCF and benefit-risk profile analysis.

In January 2025, Health Canada published a new guide on the use of recognized standards to demonstrate compliance with the requirements of the Medical Devices Regulations. The document guides manufacturers in preparing submissions, updates and lifecycle management of applicable standards.