Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2024

USA

Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The guidance provides a framework for determining whether, and what type of, long-term neurologic, sensory, and developmental evaluations may be useful to assess the safety of a “medical product” (such as a drug, biological product, or device) for use in neonates. Additionally, it helps identify which neurodevelopmental domains are most relevant for evaluating safety in this population.

Guidance on Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway

The guidance establishes performance criteria for root-form endosseous dental implants and abutments under the Safety and Performance Based Pathway, allowing 510(k) submitters to demonstrate substantial equivalence using these criteria instead of direct comparison to predicate devices. Submitters should refer to the FDA Recognized Consensus Standards Database for relevant standards and include supporting documentation if declaring conformity to a recognized standard. Implemented without prior public comment under section 701(h)(1)(C)(i) of the FD&C Act, this guidance is intended as a less burdensome approach aligned with public health goals and is open to comments per FDA’s good guidance practices. It applies to Class II devices regulated under 21 CFR 872.3640 (product code DZE) and 21 CFR 872.3630 (product code NHA).

EUROPE

Q&A In Case of Interruption or Discontinuation of Supply Of Certain Medical Devices and in Vitro Diagnostic Medical Devices

The Q&A document addresses practical aspects related to the implementation of the Article 10a obligation concerning interruptions or discontinuations of supply for certain medical devices, as introduced by Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746. It covers three main areas: the gradual roll-out of Eudamed systems to enhance device registration and monitoring, the obligation for manufacturers to notify relevant authorities and health institutions in the event of supply disruptions, and the transitional provisions for specific in vitro diagnostic medical devices. The guidance aims to assist stakeholders in navigating these requirements effectively to ensure compliance and continuity in device supply.

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

The document explains the important differences between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on medicinal products for human use (MPD). Understanding these differences is key to properly applying and enforcing these laws. The document clarifies several rules in both the MDR and MPD to help ensure the MDR is applied consistently across the EU.

The document starts with a general overview of the differences between medical devices and medicinal products, including definitions and examples. It also includes specific sections on herbal products, substance-based devices, and combinations of medical devices and medicinal products.

Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

The regulatory status of ethylene oxide (EtO) for sterilizing single-use medical devices has been examined in the context of the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). EtO is commonly used to sterilize a variety of medical products, including medical devices, in vitro diagnostic medical devices (IVDs), and medicinal products, as well as their combinations. The sterilization process, which is essential for products marketed in sterile condition, typically occurs in large industrial facilities operated by manufacturers or external sterilization service providers. Additionally, EtO is available in cartridges designed for the sterilization of reusable medical devices, primarily within healthcare settings. These cartridges, which supply EtO to specific sterilizers, are usually CE marked under either the previous Directive 93/42/EEC or the current Regulation (EU) 2017/745 on medical devices (MDR).

Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

Regulation (EU) 2023/607 has amended the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR). In particular, the transitional period has been extended from May 26, 2024, to December 31, 2027, or December 31, 2028, depending on the device’s risk class and certain conditions. The document offers updated guidance on how MDR requirements apply to “legacy devices” and “old” devices, reflecting the recent amendments to the MDR transitional provisions. Additionally, the annex includes a non-exhaustive table that outlines which MDR requirements are applicable or not applicable to these “legacy devices.”

Guidance on qualification of in vitro diagnostic medical devices

The guidance document clarifies which products fall under Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) and outlines the criteria for classification as an IVD or an accessory. To qualify, products must align with the definitions in Articles 2(2) or 2(4) of the IVDR, based on the manufacturer’s intended purpose. It is important to note that the IVDR is distinct from Regulation (EU) 2017/745 on medical devices (MDR), which does not cover IVDs. The document provides examples of IVDs and their accessories, with more detailed examples in the Manual on Borderline and Classification. Manufacturers must assess each product individually, as qualification may differ based on intended use.

Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

The guidance document is for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). It should be read along with MDCG 2022-13, which explains how CABs and NBs are designated and reassessed, and it provides templates to use during assessments. While using these templates isn’t required, they can make the review process for corrective and preventive actions (CAPA) easier.

The document explains how NBs should create CAPA plans for addressing non-compliances (NCs), how DAs should review these plans, and how JATs should evaluate them along with the DAs’ opinions. It highlights the importance of accurately repeating the wording and classifications of NCs in the CAPA template. Clear communication throughout the CAPA process is crucial for timely and effective reviews by JATs.

AUSTRALIA

TGA responds to questions on essential principles, clarifying effect on industry

The TGA has published responses to questions from a public consultation on the essential principles for regulating medical devices in Australia. These principles outline the safety and performance requirements for devices sold in the country. Following a recent presentation on aligning Australian regulations with EU standards, TGA addressed additional questions, detailing plans to update the essential principles checklist and support manufacturers through transition periods, guidance, and compliance tools. While sponsors won’t need to report their compliance with amended principles, manufacturers will be required to retain evidence of compliance.

Amendment: Guidance on the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices)

The guidance aims to assist sponsors and manufacturers of ‘unapproved’ therapeutic vapes in understanding the minimum quality and safety requirements for these devices. It is specifically focused on requirements for ‘unapproved’ therapeutic vapes under MDSO 2024 and applies only to therapeutic vapes intended for smoking cessation or the management of nicotine dependence.

BRAZIL

ANVISA informs that change in the petition for clinical research of medical devices

Anvisa informs that requests for clinical research on health products have migrated to the Solicita system.

The change aims to improve the experience of the regulated sector, as requests and monitoring of requirements will be done centrally.

FINLAND

Medical device operator: check the information entered in the register for the control fee to be confirmed in 2025

Under Section 50 of the Medical Devices Act (719/2021), Fimea charges a monitoring fee to medical device operators who must report annually, with fees applied separately for each registered role (e.g., distributor and manufacturer). Operators must update their information in Fimea’s register by December 31, 2024, as the 2025 monitoring fee will be based on the data available by that date. The fee will still be charged unless the operator submits a notification of activity cessation by December 31, 2024, either electronically in the CERE or EUDAMED databases, or in writing to Fimea. The fee is waived if Fimea confirms the end of operations by the deadline.

INDIA

Medical Device Adverse Event Reporting Form

The form is intended to collect information on Medical Devices Adverse Event in India. The form is designed to be used by Manufacturer/Importer/ Distributor of Medical Devices and Healthcare Professionals with direct/indirect knowledge of Medical Devices Adverse Event.

IRELAND

Frequently Asked Questions on Notification for In-house Manufacturers of Medical Devices and in vitro Diagnostic Medical Devices

The guide is intended to inform in-house manufacturers of the requirement to notify the Health Products Regulatory Authority (HPRA) of their activities and to provide clarity on the process and information to be provided.

SAUDI ARABIA

Guidance on Innovative Medical Devices

Innovative Medical Devices play a key role in enhancing the quality of life for patients and healthcare providers. To reduce delays in accessing these advanced technologies, the SFDA has introduced a pathway to expedite regulatory processes, ensuring faster access to devices with significant diagnostic, treatment, or monitoring advantages. This guidance outlines the criteria for designating a device as innovative, the review process, and submission requirements under the Innovative Medical Devices Pathway. It is intended for innovators, developers, manufacturers, and authorized representatives seeking Marketing Authorization for such devices.

SFDA Guidance on Content of Labeling of Contact Lenses and its Solutions

The purpose of the guidance document is to define and clarify the contents of the labeling of contact lenses and its solutions that shall be provided within MDMA application and it is applicable to manufacturers and ARs of contact lenses and its solutions.

THAILAND

FDA reduces approval and licensing procedures, maintaining the safety of medical devices as a top priority

The FDA is reducing steps and requesting documents for medical device approvals, aiming to reduce duplication and maintain effectiveness and safety. The FDA supports the Ministry of Public Health’s policy promoting the health economy industry, facilitating entrepreneurs in developing quality standards. Four announcements have been issued, reducing the burden on entrepreneurs and maintaining the efficiency and safety of medical devices.

UNITED KINGDOM

Update: Guidance on Clinical investigations

As part of the process to obtain UKCA, CE, or CE UKNI marking for your medical device, a clinical investigation may be required. And required to notify the MHRA at least 60 days prior to commencing the investigation. Detailed information on how to submit your notification to the MHRA regarding your intention to conduct a clinical investigation for medical devices can be found in the relevant guidelines.