USA
Laboratory Developed Tests (LDTs) – Small Entity Compliance Guide
FDA issued a Small Entity Compliance Guide following the final Laboratory Developed Tests (LDT) Rule. The rule clarifies that in vitro diagnostic products (IVDs), including those developed by laboratories, are regulated as medical devices under the FD&C Act. The guide helps smaller organizations understand and comply with the applicable regulatory requirements.
Guidance on Delaying, Denying, Limiting, or Refusing Inspections
FDA released guidance explaining the actions and circumstances that may be considered delaying, denying, limiting, or refusing a drug or medical device inspection under Section 704 of the FD&C Act, consistent with Section 501(j).
Canada
Transparency Principles for Machine Learning-Enabled Medical Devices
FDA, Health Canada, and the MHRA introduced guiding principles to improve transparency for machine learning-enabled medical devices (MLMDs). Building on Good Machine Learning Practice (GMLP), the principles emphasize effective human-AI interaction, clear communication with users, and adoption of transparent development practices.
Europe
Clinical Evaluation of Orphan Medical Devices
The MDCG published guidance describing how medical devices and accessories may qualify as orphan devices under MDR (EU) 2017/745. The guidance supports manufacturers and notified bodies in meeting clinical evidence requirements and facilitates access to EMA expert panel advice on orphan status and clinical data expectations.
Updated SCHEER Guidance on Phthalates
SCHEER revised its benefit–risk assessment guidance for phthalates used in medical devices. The update includes terminology refinements and additional annexes covering recent developments in alternative plasticizers, exposure assessment, and toxicological evidence.
Device-Specific Vigilance Guidance
A new Device Specific Vigilance Guidance (DSVG) document harmonizes vigilance reporting for CE-marked urogynaecological surgical mesh implants. It clarifies manufacturers’ obligations for reporting incidents and serious incidents under MDR (EU) 2017/745.
Finland
Public Access to Operator Information
Fimea announced that organizations registered in Finland’s CERE database will be listed publicly, improving transparency and supporting procurement authorities and stakeholders in line with EUDAMED principles.
Germany
Reporting SAEs and Product Defects
German guidance reiterates MDR requirements for reporting serious adverse events and product defects in medical device clinical investigations, including applicable reporting forms and timelines.
Statistical Requirements for Clinical Investigations
Authorities recommend incorporating statistical planning and analysis requirements defined in DIN EN ISO 14155 into clinical investigation plans to ensure scientifically robust trial applications.
Italy
Orphan Medical Device Guidance
Italy highlighted the MDCG orphan device guidance as an important step in improving access to medical devices for patients with rare diseases while supporting compliance with MDR clinical evidence requirements.
Switzerland
Swissdamed Actors Module
Swissmedic announced that the Actors module of the Swissdamed database will become operational on August 6, 2024. Until July 26, 2024, CHRN registrations and updates will continue through PDF forms before transitioning to the new system.
United Kingdom
Software and AI as Medical Devices
Updated UK guidance reflects the growing role of software and AI in healthcare, references transparency principles for machine learning-enabled medical devices, and provides additional resources for developers.
Japan
Compassionate Clinical Trials
Japan updated information on its compassionate use framework, allowing eligible patients with serious or life-threatening conditions to access investigational medical products when no suitable alternatives or trial participation options exist.
South Korea
IVD Medical Devices Act Amendment
South Korea announced amendments to the Enforcement Rules for the In Vitro Diagnostic Medical Devices Act, expanding eligibility for clinical performance testing institutions and strengthening oversight and compliance procedures.
Srilanka
Manufacturing Site Registration
The NMRA instructed medical device marketing authorization holders to submit manufacturing site registration details through its online portal, together with supporting approval documents, by July 31, 2024.
