January 2024 – Medical Devices Regulatory Insights
MHRA sets out a new Roadmap to protect patient safety and allow access to medical technology including AI and diagnostics.
Medicines and Healthcare Products Regulatory Agency (MHRA) has published a roadmap for developing new and robust regulations for medical devices in the UK and are designed to provide greater international harmonisation.
Access roadmap for 2024/2025 here:
https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf
The measures to protect patient safety will be put in place in 2024, and the new framework’s core elements will be in place by 2025.
Source: Gov.uk. Published: 9 January 2024. Full article:
https://www.gov.uk/government/news/regulatory-roadmap-points-the-way-ahead-for-new-measures-to-support-safe-access-to-medical-technology-including-ai-and-diagnostics
Guidance documents issues by the Medical Device Coordination Group (MDCG)
MDCG has issued guidance documents over the past three months, see below. On January 9th the European Commission published a DASHBOARD which presents the data of the ongoing study “Monitoring availability of medical devices on the EU market”, the study is planned to run until December 2025.
October 2023
MDCG 2023-4: Guidance on MDSW intended to work in combination with hardware or hardware components.
Commission delegated Regulation (EU) 2023/2197 as regards the assignment of UDI for contact lenses.
November 2023
MDCG 2022-11– Rev 1: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.
December 2023
(EU) 2023/2713: European Union reference laboratories in the field of in vitro diagnostic medical
devices.
MDCG 2021-6-Rev.1: Questions and Answers regarding clinical investigation.
MDCG 2023-5: Guidance on qualification and classification of Annex XVI products.
MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products.
MDCG 2021-27-Rev.1: Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
MDCG 2023-7: Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR.
MDCG 2019-07 Rev.1: Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’.
Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks.
The implementing act includes transitional arrangements to allow the EURLs to form a network and harmonize their working methods, and for manufacturers and notified bodies to adapt their processes to include EURL testing. The EURLs are expected to take up their tasks in conformity
assessment of devices on 1 October 2024.
The act includes provisions to minimize disruption to ongoing conformity assessment processes. In particular, only new applications submitted to notified bodies after the end of the transition period will be subject to performance verification by the EURLs. On the other hand, batch testing of devices already CE-marked under Regulation (EU) 2017/746 will begin after the end of the transitional period to ensure appropriate control of those IVDs.
Original source: EU. Published: 06 December 2023 Full article: Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
Manufacturers register now for MDR technical documentation training
The third session is fully booked, the TEAM-NB set up a new date for the fourth session on 27 March 2024. To register click here: Register
The FDA issue new guidance document for Premarket Notifications for Magnetic Resonance Diagnostic Devices
This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification. The approach outlined in this guidance document is intended to facilitate the timely review and marketing clearance of MRDDs. The guidance reflects an update to harmonize with the 4th edition of the FDA recognized standard IEC 60601-2-33 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.
Original source: FDA. Published: 10 October 2023 Full article: Guidance document for premarket
notifications for MRDD
The FDA issue enforcement policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions
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 FDA intends this policy to help address current manufacturing limitations, potential shortages or supply chain challenges that may be alleviated or mitigated by adding production lines or manufacturing at alternative sites. Such sites may have different manufacturing equipment that can increase manufacturing capacity and supply and/or reduce supply chain interruptions and manufacturing bottlenecks
The policy set forth in this guidance does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain challenges. Published 2 November 2023: PMA/HDE enforcement policy
The FDA withdrew as member of Global Harmonization Working Party (GHWP).
The FDA joined the party in 2021 but announced its withdrawal in November 2023. The FDA will continue to reach global partners to ensure alignment of medical device international harmonization. The FDA will continue their collaborative work to make safe and effective medical devices available globally as the chair of International Medical Device Regulators Forum (IMDRF).
Original source: FDA Published: 27 November 2023. Full article: FDA withdrawal from GHWP letter
The FDA has updated the sterilization guidance for medical devices.
On 8 January 2024 an update was made to final guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile. Vaporized hydrogen peroxide (VHP) is now considered an Established Category A sterilization process. The updated guidance provides industry with revised recommendations on the information to provide in future 510(k) submissions that use VHP. Moving VHP from Established Category B to Established Category A reduces the regulatory burden on manufacturers using this sterilization process for devices that need a 510(k).
Original source: FDA. Published: 8 January 2024. Full article: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile | FDA
FDA: eSTAR Program update
On 6 December 2023 an update on the eSTAR program announced voluntary use for Premarket Approval Applications are now available. All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the final guidance.
Find electronic submission template for medical device 510(k) submissions here: Electronic Template
Original source: FDA. Published: 6 December 2023 Full article: eSTAR program update
Medical device advisory committee meeting, open to public.
The FDA announced a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. The meeting will take place virtually on 13 February 2024, from 9 a.m. to 6 p.m. Eastern Time.
Webcast information and link click here.
Health Canada (HC) issue exemption for Type III recalls from mandatory reporting
Traditionally, recalls have been categorized into three types based on the level of risk they pose to consumers’ health:
- Type I: Recalls involve products that could cause serious health problems or death.
- Type II: Recalls pertain to products that may cause temporary health problems or pose a
slight threat. - Type III: Recalls include products that are unlikely to cause any adverse health consequences.
However, HC is prosing to eliminate the mandatory reporting of type III recalls. This change would align the reporting requirements in Canada with international standards set by organizations like the IMDRF, US and EU. This change will reducing the administrative obligations imposed on industry and Health Canada associated with Type III recalls will lead to increased efficiency in managing safety recalls.
Original source: McMillan. Published: 3 January 2024.
Full article: Update to HC medical device regulation
Brazil’s medical device market regulator ANVISA announced update to IVD legislation.
The new legislation aligns the IVD regulatory administrative procedures with that of medical devices (RDC 751/2022), which will be effective as of 1 June 2024.
Minor changes were made to IVD classification or grouping and adopted the definition of IVD from the EU IVDR 2017/746, Article 2(2). Also, the submission of the technical dossier must now be organized according to IMDRF/RPS WG/N13 (Edition 3) FINAL:2019 – In Vitro Diagnostic Device Market Authorization Table of Contents (lVD MA ToC).
Original source: Emergo by UL. Published: 21 December Full article: Brazil ANVISA revised IVD regulation
References
Image 1: https://thehealthcareinsights.com/essential-medical-devices-that-should-be-available-at-your-home/
Image 2: PowerPoint Presentation (publishing.service.gov.uk)
Image 3: US FDA electronic Submission Template and Resource (eSTAR) | Emergo by UL