USA

Medical Device User Fee Rates for Fiscal Year 2025

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for the fiscal year (FY) 2025. This notice establishes the fee rates for FY 2025, applicable from October 1, 2024, through September 30, 2025. It provides details on how the FY 2025 fees were determined, outlines the payment procedures, and explains how businesses can qualify for reduced small business fees.

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use

The guidance is for pivotal clinical studies on devices treating Opioid Use Disorder (OUD) and supporting marketing submissions. It helps sponsors and investigators design studies ensuring the safety and effectiveness of these devices. While focusing on well-controlled pivotal studies, the recommendations can also apply to other studies generating valid scientific evidence.

CANADA

Regulatory enrolment process (REP) 

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to:

• Company
• Dossier and product
• Regulatory activity
• Regulatory transaction

REP consists of web-based templates that capture information in a structured format. This process enables a shift towards a common submission intake across product lines and allows Health Canada to:

• Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG)

Automate the import of regulatory transactions into its repositories

EUROPE

MDCG 2020-16 rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

The guidance addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules.

MDCG 2020-16 revision 3 made changes on addition of ‘kit’ definition, Rule 3(a) Revision of examples, Rule 4(a) Revised, Rule 5(c) Revised, Rule 6 Minor revision of example.

Update – MDCG 2021-5 Rev.1 – Guidance on standardization for medical devices

The document aims to provide guidance on various aspects related to standards in the medical devices sector, supporting the requirements outlined in the applicable EU legislation, while considering its specificities.

CZECH REPUBLIC

Agenda for registration of persons

Effective 1 July 2024, the agenda for the registration of persons has been transferred from the Department of Registration and Notifications (RAN) to the Department of Systems (SYS). This transfer involves processing notifications in the Information System of Medical Devices (ISZP) related to distributors, service providers, and manufacturers of custom-made devices, as specified in § 23 of Act No. 375/2022 Coll. It also includes fulfilling obligations under the transitional provision of § 74 paragraph 7 of Act No. 375/2022 Coll., concerning the registration of activities of manufacturers, authorized representatives, and importers in the Register of Medical Devices (RZPRO). Additionally, the SYS department handles requests for the allocation of a single registration number for the Federal Republic of Germany in the EUDAMED database.

ITALY

Medical devices and in vitro diagnostic medical devices, new EU provisions

The Regulation amends the provisions on the mandatory use of the European database of medical devices (EUDAMED) for devices compliant with the Regulations and for legacy devices. It also introduces the obligation for manufacturers to provide advance notice of the interruption or cessation of supply of a device that is likely to cause serious harm or pose a risk of serious harm to patients or public health.

PORTUGAL

Transition period of the European Clinical Trials Regulation No. 536/2014 of 16 April Ends on 30 January 2025

The transition period of the European Clinical Trials Regulation No. 536/2014 of April 16 ends on January 30, 2025. Therefore, if a promoter of clinical trials authorized under Directive No. 2001/20/EC of April 4, and which are expected to take place after January 30, 2025, must act now to transfer them to the Clinical Trials Information System, CTIS.

Regulation (EU) 2024/1860 introducing amendments to Regulations (EU) 2017/745 and (EU) 2017/746

Regulation (EU) 2024/1860 has been published, amending Regulations (EU) 2017/745 and (EU) 2017/746. It addresses the progressive availability of Eudamed, the obligation to provide information in case of supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic (IVD) medical devices. This regulation aims to ensure the market availability of essential IVDs for healthcare by giving manufacturers more time to comply with the new rules under Regulation (EU) 2017/746 (IVDR), while maintaining safety and reducing the risk of shortages.

SWITZERLAND

Guidance document on Vigilance contact person for medical devices

The document is intended to provide hospitals, particularly the vigilance contact persons for medical devices, with an overview of the development steps a device undergoes before it is placed on the market and its post-market surveillance. It focuses on the contribution made by hospitals to this process, explaining the requirements for the hospital reporting system and the role of the vigilance contact person.

Information sheet on Clinical investigations with medical devices

Information sheet is intended for sponsors of clinical investigations of devices, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

Information sheet Performance studies with IVD

Information sheet is intended for sponsors of performance studies with IVD, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance by the Swiss Agency for Therapeutic Products, Swissmedic.

UNITED KINGDOM

Update: Guidance on Medical devices: UK approved bodies

The guidance provides list of UK approved bodies and types of medical devices for which the approved body is permitted to issue UKCA certification.