USA
Guidance on Laboratory Developed Tests: Small Entity Compliance Guide
FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (89 FR 37286) (“LDT Final Rule”). The final rule amends FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. FDA has prepared the Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.
Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
The guidance covers facilities that are subject to drug or device inspection under section 704 of the FD&C Act. The guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j) of the FD&C Act.
Canada
Guiding Principles On Transparency for Machine Learning-Enabled Medical Devices
The FDA, Health Canada and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). These principles build upon the: Good machine learning practice for medical device development (GMLP) principles especially:
Principle 7: Focus is placed on the performance of the human-AI team
Principle 9: Users are provided clear, essential information
These guiding principles are intended as considerations when adopting and advancing good transparency practices.
Europe
New MDCG Guidance on Clinical Evaluation of Orphan Medical Devices
The Medical Device Coordination Group (MDCG) has issued new guidance explaining how a medical device or its accessory may qualify as an “orphan device” under the Medical Devices Regulation (EU) 2017/745 (MDR). The document supports manufacturers and notified bodies in fulfilling MDR clinical evidence requirements while addressing challenges that often delay patient access to orphan devices. The guidance also enables manufacturers and notified bodies to request advice from expert panels coordinated by the European Medicines Agency (EMA) regarding orphan status and necessary clinical data for evaluation.
Update – Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) guidelines phthalates
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has revised its guidance regarding the benefit–risk assessment (BRA) of phthalates used in medical devices under the MDR. These substances may have carcinogenic, mutagenic, reproductive toxicity (CMR), or endocrine‑disrupting (ED) properties. The updated version mainly introduces minor terminology revisions related to identifying alternatives to CMR or ED phthalates. Additional annexes provide updated insights on developments over the past five years concerning the use, exposure assessment, and toxicological data for alternative plasticizers.
Update on SCHEER Guidelines for Phthalates in Medical Devices
A new Device Specific Vigilance Guidance (DSVG) document has been issued to harmonize vigilance reporting for CE‑marked urogynaecological surgical mesh implants used in the treatment of pelvic organ prolapse and stress urinary incontinence. The guidance clarifies reporting requirements for incidents and serious incidents that manufacturers must submit to competent authorities in accordance with MDR (EU) 2017/745.
Finland
Public Availability of Medical Device Operator Information
Organizations operating in the medical device sector must register either in the European EUDAMED database or in Finland’s national CERE register. The Finnish Medicines Agency (Fimea) intends to publish a publicly accessible list of operators registered in the CERE database. Making this information available will enhance transparency and assist procurement authorities and other stakeholders, consistent with the public accessibility principles applied within EUDAMED.
Germany
Reporting Serious Adverse Events and Product Defects in Clinical Trials
Since the MDR came into force on May 26, 2021, all clinical trials involving medical devices submitted to national federal authorities must comply with MDR requirements related to reporting serious adverse events (SAEs) and product defects (DDs). These obligations are defined in Regulation (EU) 2017/745 together with the Medical Devices Implementation Act (MPDG). Guidance documents also outline the specific reporting forms and applicable timelines for submitting SAE and DD reports.
Statistical Requirements for Medical Device Clinical Trial Applications
According to DIN EN ISO 14155, the international standard governing clinical investigations of medical devices involving human participants, statistical methods used in clinical trials must meet rigorous scientific and methodological standards. The standard specifies requirements for statistical planning and data analysis. Authorities therefore recommend that sponsors incorporate these statistical considerations into the clinical investigation plan when preparing trial applications.
Italy
Guidance on Clinical Evaluation of Orphan Medical Devices
Italy has emphasized the importance of the MDCG guidance on orphan medical devices as a key development for patients with rare diseases who often have limited diagnostic and therapeutic options. The document outlines the criteria used to determine whether a medical device or accessory qualifies as an orphan device under MDR (EU) 2017/745. It also supports manufacturers and notified bodies in demonstrating compliance with clinical evidence requirements while helping address barriers that delay patient access to these devices.
Switzerland
Launch of the First Module of the Swissdamed Medical Device Database
Due to the absence of an updated Mutual Recognition Agreement (MRA) with the European Union, Swissmedic does not currently have access to the EU’s EUDAMED database.
Consequently, since May 26, 2021, Swiss economic operators—including manufacturers, importers, and authorized representatives—have been required to register with Swissmedic to obtain a Swiss Single Registration Number (CHRN).
This process will change when the Actors module of the Swissdamed database becomes operational on August 6, 2024. Until July 26, 2024, applications and updates for CHRN registration will continue to be accepted via PDF forms, after which the forms will no longer be used.
United Kingdom
Updated Guidance on Software and Artificial Intelligence as Medical Devices
Software technologies, including artificial intelligence, are playing an increasingly important role in healthcare and social care systems. In the United Kingdom, many software solutions are regulated as medical devices or in vitro diagnostic devices (IVDs). Updated guidance now references the newly introduced transparency principles for machine learning‑enabled medical devices and provides links to outputs from the Software Group to support developers and other stakeholders.
Japan
Updated Information on Compassionate Clinical Trials
Japan has introduced a framework that allows patients with serious or life‑threatening illnesses to access investigational drugs, medical devices, or regenerative medicine products that have not yet been approved. This compassionate use program is intended for patients who cannot participate in clinical trials and who lack effective treatment alternatives. The pathway generally applies to clinical trials in the final phase of domestic development, where the likelihood of therapeutic benefit is considered relatively high.
South Korea
Announcement of partial amendment to the Enforcement Rules for In Vitro Diagnostic Medical Devices Act
A partial amendment to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act will come into effect on July 3, 2024. Under the revised rules, institutions that are not officially designated by the Minister of Food and Drug Safety will also be permitted to participate in clinical performance testing of IVD medical devices. The amendment also introduces additional requirements for managing and supervising clinical testing institutions and establishes procedures for addressing non‑compliant devices.
Srilanka
Introducing a procedure for collecting of manufacturing site registration details
The National Medicines Regulatory Authority (NMRA) has instructed all Medical Device Marketing Authorization Holders to submit manufacturing site registration details through a designated online portal if their information is not already recorded. Applicants must upload a scanned copy of the manufacturing site approval letter or other registration documents for verification. All required information must be submitted no later than July 31, 2024.
