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

USA

Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

Guidance describes a nine-step framework for assessing the credibility of computational modeling used in a medical device regulatory submission. Intends to help improve the consistency and transparency of FDA reviews of regulatory submissions that include CM&S methods. Applies to CM&S models that are physics-based or mechanistic. It does not apply to standalone machine learning or artificial intelligence-based models.

The purpose is to provide a general risk-informed framework for assessing CM&S credibility in medical device regulatory submissions that incorporate both traditional validation evidence and/or other types of supporting data. The guidance is applicable to first principles-based models (e.g., physics-based or mechanistic models), such as models commonly used in electromagnetics, optics, fluid dynamics, heat and mass transfer, solid mechanics, acoustics, and ultra sonics, as well as mechanistic models of physiological processes.

Guidance on Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act

Under section 506J, during or in advance of a PHE, manufacturers are required to submit notifications for devices that are critical to public health. This section provides additional clarification on who is required to notify FDA, when such notifications are required pursuant to section 506J, what information FDA expects manufacturers to include in such notifications, and how to submit notifications.

Food and Drug Administration (FDA) Guidance on Enforcement Policy for Clinical Electronic Thermometers

The enforcement policies in this guidance apply to clinical electronic thermometers, which are regulated as Class II devices under 21 CFR 880.2910, product code FLL. These devices include both contact and non-contact clinical electronic thermometers. FDA is proposing to exempt certain clinical electronic thermometers—specifically clinical thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements under section 510(m) of the FD&C Act.

At this time, FDA does not propose exempting these devices from other statutory and regulatory requirements. As such, the sections below (organized by clinical thermometer type) describe enforcement policies that are intended to help foster compliance with certain applicable legal requirements for these devices. FDA intends to withdraw this guidance after any final exemption notice has been published in the Federal Register.

Food and Drug Administration (FDA) reissued Guidance on Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

FDA reissued a guidance on how to request a review of its decision not to issue certain export certificates to device manufacturers. It updates details on what information the agency will provide to companies that have had a request for a Certificate to Foreign Government (CFG) denied, and the process to contest the denial.

Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions

This policy applies to limited modifications made to a device approved through the PMA program that triggers the requirement that a manufacturer submit a PMA supplement or 30-day notice to FDA per section 515(d)(5)(A) of the FD&C Act and 21 CFR 814.39. This policy also applies to limited modifications made to a device approved through the HDE program that require a manufacturer submit an HDE supplement or 30-day notice to FDA per 21 CFR 814.108.

Examples of such modifications may include, but are not limited to:

• Design and manufacturing changes to address component unavailability due to supply chain disruptions
• Manufacturing changes to allow the establishment to maintain operations and to accommodate social distancing in appropriate situations based on local conditions
• Changes in manufacturing facility or establishment
• Changes to packaging procedures

CANADA

What medical device establishment license holders need to know about annual license review for 2024

To continue doing business, holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1.

Health Canada sends the ALR package in December of each year to the establishment contact on file. Please ensure the establishment contact on file is up-to-date so you can receive your ALR package on time.

If you have ceased your licensable activities and no longer require an MDEL after April 1, 2024, you must indicate this on your ALR package using the cancellation form. We will withdraw your license. If we do not receive your application before April 1, 2024, we will cancel your license.

If you received your new MDEL before April 1, 2024, you will also need to submit an ALR package before this date. You must also pay the applicable fees when you do so. This is in accordance with section 46.1(1) of the regulations.

Revised notice on Implementing the regulatory enrolment process (REP) for medical devices regulatory activities

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. Our decision is based on the results of a pilot project, which began in November 2019 and will end in June 2024. About 40 companies participated in the pilot.

The pilot was positive. All medical device companies are now invited to begin to use this process beginning in July 2024.

EUROPE

Update – Rev 1 – MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has significantly changed. The main objectives of these two Regulations are to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation.

Enhancing the capacity of notified bodies and the efficiency of conformity assessment procedures remain a top priority for the MDCG. The actions listed in MDCG 2022-14 are showing good results, e.g. use of hybrid audits, deferral of re-assessment of notified bodies and clarification of the meaning of ‘personnel employed by the notified body’ in Article 36 (1) MDR / Article 32 (1) IVDR. The MDCG remains fully committed to pursue the implementation of the actions listed in MDCG 2022-14 and calls for the continued full commitment of other actors involved, including notified bodies and industry.

To date, 40 and 12 notified bodies are designated under the MDR and the IVDR respectively. The efficiency of the designation process has improved, and individual notified bodies have increased their internal capacity to be able to handle more applications for conformity assessment.

FINLAND

Fimea involved in the EU4Health project focusing on market surveillance of medical devices

Fimea, the pharmaceutical safety and development center, is involved in the JAMS 2.0 joint project of the EU4Health program funded by the European Commission. The purpose of the project is to harmonize the market surveillance of medical devices (including medical devices intended for in vitro diagnostics, IVD devices) in the European Union by supporting

• Regular exchange of information between market surveillance authorities;
• Cooperation related to the implementation of market surveillance measures;
• Cooperation of inspectors;
• Joint inspections targeting manufacturers and other economic operators in order to harmonize inspection activities at the Union level.

The work package focusing on inspections aims to harmonize the inspection activities of manufacturers and other economic operators (e.g. authorized representatives, importers, distributors) in accordance with the requirements of MD Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746. Fimea will play a key role, especially in harmonizing inspections targeting other economic operators.

SLOVAKIA

Notice for clients on the temporary suspension of submitting a new medical device notification via the EVAR portal

SUKL is preparing a change for clients in the process of submitting notifications via the eVar portal. For this reason, the new announcement via the eVar portal is temporarily suspended. Client can submit a new notice in paper form or through the portal slovensko.sk. Applications already submitted in the solution can be accessed after logging into the eVar portal via a variable symbol and control code. Distributor registration through the eVar portal is still possible.

Notice for sponsors of clinical trials regarding the submission of the Annual Report on the current status of the clinical trial, which is carried out according to Regulation no. 536/2014

Since 1st August 2023, sponsors have been obliged to send the Annual Report on the current status of the clinical trial to the State Institute for Drug Control (SIDC) and the Ethics Committee for Clinical Trials (EC) on the basis of Article 29n (paragraph 3, letter d) of the Act No. 362/2011 Coll. As there is an ongoing discussion on how to submit the Annual Reports, sponsors do not have to submit them until SIDC and the EC issue guidance on the submission of Annual Reports on the current status of clinical trials. The SIDC and the EC will inform sponsors about the guidance via the website. At the same time, sponsors are requested to subsequently submit the Annual Reports that should have been submitted since 1st August 2023 according to the issued guidance.

SPAIN

The AEMPS reports the possibility that the plug, of certain serial numbers, of the CardioMEMS patient electronic system may deteriorate if it is manipulated or bent repeatedly

The Spanish Agency for Medicines and Health Products (AEMPS) has been aware, through the company Abbott, of an increase in reports about the breakage or deterioration, over time, of the electrical connection plug of certain serial numbers. of the CardioMEMS patient electronic system (PES). These reports state that the electrical connection plug may deteriorate or become worn if it is repeatedly manipulated or bent more than 90 degrees, which could result in the PES not turning on or causing a slight shock or crackling sound.

The PES CardioMEMS is a portable system that allows the patient to measure daily pulmonary artery pressure from home, allowing their healthcare professional to manage the patient’s heart failure more effectively. This device is part of the CardioMEMS HF system and includes, in addition to the electronic patient unit, a receiving antenna and a handheld unit, which are not affected by these incidents.

The company is sending a warning note to healthcare professionals and patients/users who have the affected products, to inform them of the problem detected, the associated risks and the actions to be taken to prevent the plug from deteriorating.

The AEMPS publishes the results of the campaign to control the market for health products for glycemic control

The Spanish Agency for Medicines and Health Products (AEMPS) has published the report of the campaign to control the market for health products for glycemic control, on the occasion of World Diabetes Day.

Technological evolution in recent years has produced a positive impact in terms of glycemic management. For this reason, and due to the high prevalence of diabetes mellitus (DM) in the Spanish population, it has been considered necessary to focus the campaigns of this period on this group of products.

The AEMPS began the fourth market control campaign for medical devices in April 2022, complying with the requirements established in Regulation (EU) 2017/745 on medical devices, and Regulation (EU) 2017/746 on medical devices. sanitary for in vitro diagnosis.

CZECH REPUBLIC

Updated versions of the information and advisory guidelines for the advertising of medical devices and in vitro diagnostic medical devices

The institute draws attention to the published updated versions of information and recommended guidelines for advertising medical devices and in vitro diagnostic medical devices, which are also available at https://www.sukl.cz/sukl/obecne-pokyny-a-formulare. The information and recommendations are updated due to the changes made by the amendments in the legislation concerning medical devices and in vitro diagnostic medical devices.

IRELAND

Outcome of the Process – Public Consultation on proposed fees for Human Medicines, Compliance, Medical Devices and Veterinary Medicines for 2024

The public consultations on proposed fees 2024 for Human Medicines, Medical Device and Compliance fees and Veterinary Medicines fees closed on 27 October 2023.

The HPRA would like to thank everybody who contributed to the process. Below is a document summarizing the outcome of the consultation process.

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