An EU CECP expert panel has issued a scientific opinion on a Class III intra-articular knee device, identifying limitations in the clinical evidence, benefit-risk assessment and PMCF strategy.

The EMA has updated its list of CECP opinions issued by Expert Panels for medical devices undergoing conformity assessment, covering Class III implantable and selected Class IIb devices.

Swissmedic has updated its guidance on Field Safety Corrective Actions, clarifying reporting responsibilities, electronic submissions, FSN publication, timelines, customer follow-up and data protection.

Swissmedic has updated its guidance on products without an intended medical purpose under Annex 1 MedDO, covering transitional provisions, conformity assessment, registration, economic operators and vigilance requirements.

The European Commission has adopted Implementing Regulation (EU) 2026/2083 on MyHealth@EU, setting rules for cybersecurity, interoperability, compliance checks, incident management and cross-border health data exchange.

Portugal achieved an 86% eHealth maturity score in 2023, above the EU-27 average, with strong digital access to health records and expanded healthcare provider participation.

ICH has published updated E14/S7B Questions & Answers (R1), providing new implementation support on QT/QTc prolongation, proarrhythmic risk, ECG methodology, study design and nonclinical assessment.

The FDA has issued draft guidance on electronic submission templates for PMAs and certain PMA supplements, covering eSTAR structure, technical screening, exemptions and future mandatory electronic submission requirements.

The MHRA has updated its guidance on pre-submission advice for innovative medicines, covering notification timelines, pre-submission meetings, Direct National Route, IRP, ACCESS and Project Orbis.

The MHRA has updated its guidance on patient and public involvement, covering its engagement approach, Patient and Public Community, rare disease work, ILAP, AI in healthcare and participation payments.

NIST IR 8587 provides implementation recommendations to protect identity and access tokens from forgery, theft and misuse, covering cryptographic keys, token validation, SSO, federation, APIs and cloud security.

MDSAP has issued the REPs User Access Request Form, allowing requests for new users, user updates and deactivation, with defined roles for Auditing Organizations and Regulatory Authorities.

Health Canada has updated POL-0001, its national compliance and enforcement policy for health products, covering medical devices, regulated activities, inspections, risk-based enforcement and corrective actions.

The COMBINE programme has published a new sponsors’ guide on safety reporting in combined studies under the CTR, MDR and IVDR, covering responsibilities, reporting timelines, communication pathways and national requirements.

The FDA’s CDRH Regulatory Reliance Portal provides practical resources for regulatory authorities using FDA medical device decisions, databases, inspections and post-market information in reliance-based pathways.

The TGA has updated guidance on mandatory statements and prominently displayed information in therapeutic goods advertising, including requirements for medical devices, social media, online sales and health warnings.

MDSAP has updated its QMS Management Responsibility and Management Review Procedure, clarifying responsibilities, management review frequency, review inputs, quorum requirements and follow-up of action items.

The European Commission has published three new templates to support written input from patients, carers and clinicians during joint clinical assessments, including scoping-phase templates and a comment form.

MedTech Europe has published a position paper arguing that reusability should not become the regulatory default for single-use medical devices under MDR Article 17, while supporting safe, evidence-based reprocessing.

The UK Health Bill 2026 proposes new powers to establish a medical device licensing regime for Great Britain, enabling MHRA to directly assess and license devices through future secondary legislation.