USA
Voluntary Malfunction Summary Reporting (VMSR) Program
The VMSR Program allows medical device manufacturers to submit certain malfunction reports to the FDA in quarterly summary format instead of individual reports. Participation is voluntary and does not require prior FDA approval. Manufacturers may withdraw at any time but must resume individual reporting within 30 days and revise internal procedures accordingly. The program enhances FDA’s ability to monitor safety trends while ensuring sufficient data is available to detect potential risks. Eligibility criteria and reporting conditions are detailed in FDA guidance.
Small Entity Compliance Guide – Mammography Quality Standards Act (MQSA) Amendments
Mammography is essential for early breast cancer detection and depends on high-quality imaging, qualified personnel, and proper equipment maintenance. The MQSA establishes national standards covering accreditation, personnel qualifications, equipment performance, quality assurance, and communication of results. The 2023 amendments require inclusion of breast density information in reports, along with clear summaries for patients and healthcare providers. FDA guidance reflects current recommendations and is not legally binding unless specific regulatory provisions are cited.
Electronic Submission Template for De Novo Requests
FDA guidance outlines technical standards for preparing electronic De Novo classification submissions. The template supports fully electronic submissions in compliance with Section 745A(b)(3) of the FD&C Act and ensures complete organization of required information. While it does not define the specific eSTAR interface, it establishes the formatting framework. FDA will continue updating eSTAR as policies evolve and encourages public feedback.
Section 513(g) Requests for Information
This guidance explains procedures for requesting information regarding device classification and applicable regulatory requirements under Section 513(g) of the FD&C Act. It clarifies that FDA guidance documents describe the Agency’s current thinking and are recommendations unless specific regulations state otherwise.
Acceptable Media for Electronic Product User Manuals
FDA guidance confirms that manufacturers may provide user manuals in either paper or electronic format. This reflects increased reliance on digital platforms, enabling improved accessibility, quicker updates, and reduced paper consumption. These recommendations are not legally binding unless tied to specific regulatory requirements.
CANADA
Medical Device Licence (MDL) Minor Change Form – Manufacturer Name/Address Updates
Manufacturers holding existing Medical Device Licences or COVID-19 authorizations must submit a minor change form to update the manufacturer’s name or address. The guidance details documentation requirements and submission procedures.
COLOMBIA
Certification Visits for Hearing Aid Establishments
A national guide has been issued for facilities manufacturing, assembling, or repairing over-the-counter hearing aids. It outlines compliance steps aligned with Resolution 5491 of 2017, governing establishment and operation requirements. Certification is valid for five years and ensures adherence to quality standards for individuals with hearing impairments.
EUROPEAN UNION
Proposed Common Specifications for Class D IVDs
The European Commission has proposed amendments to common specifications for certain Class D in vitro diagnostic devices, expanding coverage to additional parasites and viruses of public health concern. Stakeholders were invited to provide feedback within four weeks. If adopted, the updates will revise Regulation (EU) 2017/746.
EMA Pilot Programme for Orphan Medical Devices
The European Medicines Agency has launched a pilot program offering free scientific advice to manufacturers and notified bodies developing orphan medical devices intended for rare diseases affecting up to 12,000 people annually in the EU. Using a risk-based selection model, the initiative may become permanent if successful.
CZECH REPUBLIC
Registration Reporting Obligations – Q&A
The national authority has published questions and answers clarifying reporting obligations and registration requirements for individuals involved in medical device activities.
Survey on Electronic Instructions for Use (eIFU)
The European Commission initiated a survey targeting healthcare professionals to gather input on potentially extending Regulation (EU) 2021/2226 on electronic instructions for use to all professional-use devices, while ensuring paper copies remain available upon request.
PORTUGAL
Commission Implementing Decision (EU) 2024/2120 – UDI Designation Renewal
On 30 July 2024, the European Commission renewed for five years the designation of four organizations authorized to operate Unique Device Identifier systems: GS1, HIBCC, ICCBBA, and IFA. The renewal confirms continued compliance with Regulations (EU) 2017/745 and 2017/746 requirements.
Survey on Electronic Instructions for Use (eIFU)
A Commission survey, open until 11 October 2024, seeks stakeholder feedback on expanding eIFU use for professional-use devices while maintaining free access to paper instructions upon request.
SWITZERLAND
Alignment with EU IVDR Amendments
Swissmedic aligned with EU Regulation (EU) 2024/1860, extending certificate validity for certain in vitro diagnostic devices until 2027–2029 to address notified body capacity constraints. Switzerland will implement equivalent measures to prevent supply disruptions during its transitional phase. Full product registration requirements are expected in 2026.
Launch of “swissdamed” Database
On 6 August 2024, Swissmedic launched the first module of its new medical device database, “swissdamed.” The initial “Actors” module allows online registration of economic operators. The “Devices” module will be introduced in phases starting in 2025, with mandatory registration once fully implemented.
UNITED KINGDOM
Clinical Investigation Notification – MHRA Update
Updated guidance explains how to notify the MHRA of planned clinical investigations. Manufacturers seeking UKCA, CE, or CE UKNI marking must notify the MHRA at least 60 days before commencing investigations.
Vigilance Guidance – Electronic Cigarettes
Under the Tobacco and Related Products Regulations 2016, producers must notify the MHRA before marketing electronic cigarette products and maintain systems to collect information on suspected adverse effects. Non-compliant or unsafe products must be corrected, withdrawn, or recalled.
Export of Medical Devices – Certificate of Free Sale
Guidance clarifies the process for obtaining a Certificate of Free Sale for exporting medical devices. The MHRA issues certificates only for registered devices and does not confirm compliance with importing country requirements.
HONG KONG
Updated Classification of General Medical Devices
Under the Medical Device Administrative Control System, general medical devices are classified into four risk categories (Class I–IV). The latest update revises Rule 14 under Clause 7.1, refining classification criteria.
INDIA
Online Portals for Adverse Drug Monitoring and Pharmacopoeia
India has launched two digital platforms: one for its Adverse Drug Monitoring System and another providing access to Indian Pharmacopoeia standards. The ADRMS portal streamlines adverse event reporting related to medicines and medical devices by patients, healthcare professionals, and industry stakeholders.
