Medical Devices – USA/Europe Regulatory News – Dec. 2023

USA

FDA Guidance on Assessing Credibility of Computational Modeling and Simulation

The FDA has issued guidance detailing a nine-step framework to assess the credibility of computational modeling and simulation (CM&S) included in medical device submissions. The framework aims to support consistent and transparent review processes. It applies to physics-based or mechanistic models used across areas such as optics, electromagnetics, heat transfer, fluid dynamics, solid mechanics, acoustics, and physiological modeling. It does not apply to standalone artificial intelligence or machine learning models.

Guidance on 506J Notification Requirements

Under Section 506J of the FD&C Act, manufacturers of devices deemed critical during or ahead of a public health emergency (PHE) must notify the FDA in cases of permanent discontinuance or manufacturing interruptions. The guidance clarifies who must submit notifications, required timing, the type of information expected, and submission procedures.

Enforcement Policy for Clinical Electronic Thermometers

The FDA has issued enforcement guidance concerning clinical electronic thermometers regulated under 21 CFR 880.2910. The agency proposes exempting certain thermometers—specifically those without telethermography or continuous-measurement capabilities—from premarket notification requirements, while maintaining all other applicable regulatory obligations. The FDA intends to withdraw the guidance once final exemption notices are issued.

Process for Requesting Review of Denied Export Certificates

The FDA has updated guidance describing how device manufacturers may request a review when the agency denies the issuance of specific export certificates, including Certificates to Foreign Government (CFGs). The update clarifies the information FDA will provide and the steps manufacturers may take to contest a denial.

Enforcement Policy for Certain PMA and HDE Supplements

The FDA’s enforcement policy covers limited modifications to devices approved under PMA or HDE pathways that may require PMA/HDE supplements or 30-day notices. Examples of modifications include:

• Design or manufacturing changes due to component shortages 
• Operational adjustments supporting social distancing 
• Manufacturing site or facility changes 
• Packaging procedure updates 

CANADA

Annual License Review (ALR) Requirements for 2024

Health Canada reminds Medical Device Establishment License (MDEL) holders that ALR submissions must be completed before April 1 annually. Establishments that have ceased licensable activities must indicate this on the ALR cancellation form. Failure to submit by the deadline results in license cancellation. New MDEL holders are also required to submit an ALR package and pay associated fees.

Regulatory Enrolment Process (REP) Implementation

Health Canada is expanding the use of the Regulatory Enrolment Process (REP) and the Common Electronic Submissions Gateway (CESG) to all medical device regulatory activities beginning July 2024. This follows a positive outcome from a multi-year pilot program initiated in 2019.

EUROPE

Updated MDCG Position Paper on MDR/IVDR Implementation

The Medical Device Coordination Group (MDCG) has updated its position paper on ensuring timely compliance with MDR and IVDR requirements. Notified body capacity continues to increase, with 40 bodies designated under the MDR and 12 under the IVDR. Progress highlighted includes hybrid audits, clarification of personnel qualifications, and deferred reassessments. The MDCG calls for continued collaboration among notified bodies, manufacturers, and other stakeholders.

FINLAND

Fimea’s Role in EU4Health Market Surveillance Initiative

Finland’s Fimea is participating in the JAMS 2.0 joint action under the EU4Health program. The initiative aims to harmonize market surveillance across the EU through:

• Enhanced exchange of information among authorities 
• Coordinated market surveillance activities 
• Joint inspections 
• Harmonized inspection practices under the MDR and IVDR 

SLOVAKIA

Temporary Changes to Device Notification via EVAR Portal

SÚKL has temporarily suspended new device notifications through the EVAR portal due to system updates. New notifications must currently be submitted in paper form or via the national portal slovensko.sk. Distributor registration through the EVAR portal remains available.

Clarification on Annual Clinical Trial Reports

Sponsors typically must submit annual clinical trial status reports under Regulation (EU) 536/2014. However, until SÚKL and the Ethics Committee publish updated submission guidance, sponsors are not required to submit these reports. Once guidance is issued, sponsors must submit all previously due reports.

SPAIN

Safety Communication: CardioMEMS System Plug Integrity Issues

AEMPS has reported potential degradation of electrical connection plugs in certain serial numbers of the CardioMEMS patient electronic system (PES). Repeated bending or manipulation may cause plug deterioration, resulting in failure to power on or minor electrical shock. Abbott is notifying healthcare providers and patients about risks and recommended precautions.

Market Surveillance Results for Glycemic-Control Devices

AEMPS has released the results of its market surveillance campaign for glycemic-control devices, conducted as part of World Diabetes Day initiatives. The campaign aligns with MDR and IVDR requirements and reflects increasing reliance on technology to support diabetes management.

CZECH REPUBLIC

Updated Advertising Guidelines for Medical Devices and IVDs

SÚKL has updated its information and advisory guidelines for advertising medical devices and in vitro diagnostic devices. Updates reflect recent legislative changes, and revised guidelines are available on the national regulatory portal.

IRELAND

Outcome of 2024 Fees Public Consultation

The HPRA has published the results of its public consultation regarding proposed 2024 fees for human medicines, veterinary medicines, medical devices, and compliance activities. The consultation closed on October 27, 2023, and the resulting summary document is publicly available.

Guidance link

https://www.hpra.ie/docs/default-source/default-document-library/public-consultation-on-human-medicines-and-medical-device-fees-2024.pdf?sfvrsn=2