USA
Medical Device User Fee Rates for Fiscal Year 2025
The U.S. Food and Drug Administration (FDA) has announced the medical device user fee rates applicable for fiscal year 2025. These fees apply from October 1, 2024 through September 30, 2025. The notice explains how the FY2025 fee amounts were calculated, outlines the procedures for submitting payments, and provides guidance on eligibility criteria for businesses seeking reduced fees under the small business program.
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
FDA guidance provides recommendations for pivotal clinical studies evaluating medical devices intended for the treatment of opioid use disorder (OUD). The document is intended to assist sponsors and investigators in designing clinical trials that adequately demonstrate device safety and effectiveness for marketing submissions. Although the guidance focuses on well‑controlled pivotal studies, its principles may also apply to other clinical studies generating valid scientific evidence.
CANADA
Regulatory Enrolment Process (REP)
Health Canada has introduced the Regulatory Enrolment Process to streamline the submission and management of regulatory information. REP uses web‑based templates to capture structured data related to companies, dossiers and products, regulatory activities, and regulatory transactions. The system supports the transition to a unified submission intake across product categories, enabling regulatory information to be received through the Common Electronic Submission Gateway (CESG) and facilitating automated integration of submissions into Health Canada’s internal repositories.
EUROPEAN UNION
MDCG 2020‑16 Rev.3 – Classification Rules for In Vitro Diagnostic Medical Devices
The updated guidance from the Medical Device Coordination Group (MDCG) provides additional clarification on the classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). Revision 3 introduces updates including the addition of a definition for ‘kit’ and revisions to examples and provisions under Rules 3(a), 4(a), and 5(c), as well as minor adjustments to examples under Rule 6.
Update to MDCG 2021‑5 Rev.1 – Standardization for Medical Devices
This document provides guidance on the role and application of standards within the medical device regulatory framework in the European Union. It supports the implementation of requirements under EU medical device legislation while considering the specific regulatory context of the sector.
CZECH REPUBLIC
Transfer of Agenda for Registration of Persons
As of 1 July 2024, responsibility for the registration of persons has moved from the Department of Registration and Notifications (RAN) to the Department of Systems (SYS). The SYS department now manages notifications submitted through the Information System of Medical Devices (ISZP) related to distributors, service providers, and manufacturers of custom‑made devices in accordance with §23 of Act No. 375/2022 Coll. The department also oversees obligations under transitional provisions regarding registration of manufacturers, authorized representatives, and importers in the Register of Medical Devices (RZPRO), as well as requests for allocation of a Single Registration Number (SRN) for Germany within the EUDAMED database.
ITALY
New EU Provisions for Medical Devices and IVDs
Updated regulatory provisions introduce changes related to the mandatory use of the European database for medical devices (EUDAMED) for both MDR/IVDR‑compliant devices and legacy devices. The regulation also introduces a requirement for manufacturers to provide advance notification if the supply of a device is expected to be interrupted or discontinued in situations that could result in serious harm or pose significant risks to patients or public health.
PORTUGAL
End of Transition Period for EU Clinical Trials Regulation
The transition period for Regulation (EU) No. 536/2014 on clinical trials will conclude on 30 January 2025. Sponsors of clinical trials previously authorized under Directive 2001/20/EC and expected to continue beyond this date must transfer their studies to the Clinical Trials Information System (CTIS) to remain compliant with the new regulatory framework.
Regulation (EU) 2024/1860 – Amendments to MDR and IVDR
Regulation (EU) 2024/1860 introduces amendments to Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). The updates address the gradual deployment of EUDAMED, requirements for notifying authorities of device supply interruptions or discontinuations, and revised transitional provisions for certain in vitro diagnostic medical devices. The objective is to maintain availability of essential IVDs while providing manufacturers additional time to meet IVDR requirements.
SWITZERLAND
Guidance on Vigilance Contact Persons for Medical Devices
Swissmedic has issued guidance intended primarily for hospitals and designated vigilance contact persons. The document outlines the lifecycle of medical devices from development through market placement and post‑market monitoring, highlighting the role of healthcare institutions in vigilance reporting and surveillance systems.
Information Sheet on Clinical Investigations with Medical Devices
Swissmedic has published an information sheet for sponsors, contract research organizations, and investigators involved in clinical investigations of medical devices. It outlines the authorization process, sponsor reporting obligations, and Swissmedic’s role in oversight and monitoring.
Information Sheet on Performance Studies with IVDs
A separate information sheet provides guidance for sponsors conducting performance studies involving in vitro diagnostic devices. It describes authorization requirements, reporting responsibilities, and Swissmedic’s supervisory role during such studies.
UNITED KINGDOM
Updated Guidance on UK Approved Bodies
Updated guidance from the UK regulator provides a list of approved bodies authorized to assess medical devices for UKCA certification. It also specifies the categories of medical devices for which each approved body is permitted to issue certification.
