Regulatory Newsletter - Edition 11
We're back with the eleventh edition of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory world! Our team of industry insiders have combed through content around the globe, from emerging trends to in-depth analysis, so you get the most pertinent issues in your industry direct to your screen.
So grab a coffee, sit back and read the latest updates in the regulatory landscape. ?? Don't forget to hit the subscribe button to make sure you never miss an edition, and share with a friend who might find it helpful!
FDA
In 2024 the FDA plans to begin the process of reclassifying the majority of high-risk class III IVDs to a more moderate risk class II. This will change the marketing clearance pathway from PMA to 510(k), increasing potential for the development of additional tests and improving access. The majority of the tests affected are those intended for diagnosis of infectious diseases, and companion diagnostics. Read more here .
EU
The EU Council has published a press release in relation to the January 23rd proposal for a gradual roll-out of Eudamed and an extension to the transitional provisions of certain IVDs. This publication confirms the Council's endorsement of the proposal and outlines the next steps for the official acceptance by the European Parliament, expected in April.
MDCG 2024-2 has been released, outlining procedures for the updates of the European Medical Device Nomenclature. As per Articles 26 and 23 of the MDR and the IVDR respectively, the EMDN is subject to annual review. This guidance document outlines the process for the annual review and the way in which feedback can be submitted. The guidance is broken into 3 short sections:
A) Actors (MDCG "NOM WG", EMDN-TT and users)
B) Procedure for the annual EMDN revision (Phases I - IV)
C) Procedure for ad-hoc updates
The results of the 6th notified body survey on certifications and applications for MDR and IVDR has been released, in relation to data from designation up to 31st October 2023. A 100% response rate was recorded from 41 MDR and IVDR representatives. As of October 2023, there had been 17, 846 applications received under MDR, with 5,599 certificates issued. Under IVDR, 1,498 applications had been received, with 702 certificates issued.
MedTech Europe has released a joint statement supporting the expansion of the use of eIFU in the medical device sector. This statement is supported by 12 organisations and petitions the MDCG to prioritise a revision of Commission Implementing Regulation (EU) 2021/2226 on eIFUs to expand the scope of product categories, allowing for more devices to benefit from the use of an eIFU. The paper is backed up by data which shows that an eIFU is favoured by the healthcare profession. Additionally, it references the environmental benefits that would be introduced by reducing paper-based IFUs, the cost-efficiency, and increased accessibility, among other advantages.
Team NB have published a position paper on their recommendations for the classification of IVDs intended to detect the presence of, or exposure to, SARS-CoV-2. These devices currently fall under Class D (Rule 1). When they were originally classified, these devices were considered high risk due to the nature of COVID-19 being a life-threatening disease, with a high risk of propogation. However, given the relatively high rate of vaccinations, among other notable arguments, Team-NB are now proposing that these devices be re-classified as either Class B or Class C devices. Arguments for both options, along with any associated consequences are provided in the paper.
The overall recommendation is for Class C, with a potential for a future reduction to Class B.
领英推荐
An informal expression of interest by EU reference laboratories is invited by the EU Commission. The remaining categories of Class D devices requiring representation are:
Expressions of interest are requested for submission to applicable Member States by 30th April 2024.
Rest of World
Health Canada has released a draft update to their guidance on how to interpret 'significant change' of a medical device. This update includes an expansion on the definition of significant change and will help manufacturers determine whether a change to a class III or IV device should be considered significant.
Comments are being accepted on the updated guidance until 22nd April 2024.
TGA has released guidance on the EU MDR Transition - Recalls and market notifications. This guidance is intended to help manufacturers and sponsors who are transitioning ARTG entries to EU MDR certification. It contains useful case studies, scenarios and decision trees to help in determining what regulatory action might be required for various scenarios during the transition period.
An Essential Principles Checklist template has been issued by TGA. The Essential Principles differ slightly from those of the EU and are a requirement for all manufacturers marketing their devices in Australia.
TGA has updated their guidance on medical device labelling obligations. This guidance provides information for both manufacturers and sponsors on their responsibilities around labelling and the information that must be provided with a medical device.
UK has formed a new approved body association called Team AB (The UK Association for Medical Device Approved Bodies). This group will provide representation for all medical device and IVD UK approved bodies with the MHRA, and support members through the navigation of regulatory changes in the UK.
Other news
A draft document has been released by IMDRF WG N81 on Medical Device Software: Considerations for Device and Risk Characterization. The document aims to provide a general strategy for the characterization of risks specific to SaMD. It will also be used to promote clarity in relation to the characterization of SaMD itself, including intended use and intended purpose statements. The draft document can be downloaded from here.
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