Regulatory Newsletter - Edition 16
We're back with the latest issue of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory world! Our team of industry insiders have been busy combing through content around the globe, from emerging trends to in-depth analysis.
Take a few minutes to 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
The Fiscal Year 2025 fees have been published by the FDA. These fees apply from 1st October 2024 until 30th September 2025 and include increases across the board. The establishment registration fee, which is payable by all establishments, has increased from $7,653 to $9,280. Detail on other fees can be found here .
The CDRH has released a discussion paper on Health Equity for Medical Devices, with the intention of gaining input from the public on the advancement of policy development on this topic. The paper examines potential considerations for the appropriate development of clinical studies for medical devices, according to the intended use of those devices, and what the FDA considers to be relevant in their evaluation of these studies. The paper is intended to promote discussion on the topic of health equity and as such comments are welcomed and will be accepted until October 4th. Feedback can be submitted here .
EU
The European Commission has published a template for a notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of EU Regulation 2024/1860. The template is intended to be used for confirmation that an application and written agreement are in place between a notified body and an IVD manufacturer to demonstrate manufacturer compliance with the provisions of an IVDR transition extension.
MedTech Europe have published a template for a Manufacturer's Declaration related to declaring compliance to Regulation (EU) 2024/1860. The template is intended for use by IVD manufacturers or their authorised representative, with respect to legacy devices CE marked under the IVD Directive 98/79/EC.
"Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices" has been published in the Official Journal of the European Union. This publication confirms the renewal of the designation of the four existing entities who were originally designated to assign UDIs for medical devices, including IVDs. The four entities are:
Following this decision, the designation of these four entities has now been renewed until 27th June 2029.
The EMA has announced the launch of a new pilot programme to provide guidance and support to manufacturers and notified bodies in relation to the development and assessment of orphan devices in the EU. The programme will run until the end of 2025, and will be made up of expert panels that can consulted during specific stages of clinical strategy development and assessment, as appropriate.
Rest of World
Health Canada has issued draft updates to both the guidance on using standards to support compliance with the Medical Device Regulations, and the list of recognised standards itself. The updates to the guidance include, but are not limited to, general updates to increase understanding, the addition of a regulatory context section, and reference to devices required for an urgent public health need.
The changes to the list of standards includes:
领英推荐
TGA has released guidance on Excluded software: Interpretation of software exclusion criteria. This guidance is intended to support sponsors, manufacturers, and software developers in understanding whether their software is subject to TGA regulatory requirements. The document goes through each exclusion criteria in the Therapeutic Goods (Excluded Goods) Determination 2018 , and provides guidance on the interpretation of whether the criteria should be considered applicable or not.
The Actors module of Swiss database on medical devices, Swissdamed, has gone live . This enables economic operators to register on the database, as of its launch on 6th August. The Devices module is set to be released over several phases, starting in 2025, but device registration will only become mandatory when the Swissdamed system has been developed sufficiently.
The MDSAP Audit Approach document has been updated to version 009 . The changes in this version include the following:
Following the 2024 Convergence, RAPS asked some of their presenters what they see as the biggest regulatory affairs trends this year. Unsurprisingly, the responses indicated a strong focus on AI. The feedback as a whole can be found here .
AI
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (The AI Act) has been published in the Official Journal of the European Union. The regulation will apply from 2nd August 2026, with the following exceptions:
The full regulation can be accessed here .
ICYMI
"Regulation (EU) 2024/1860 Of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices" has been published in the EU Official Journal. Trinzo's recent blog summarises what this means for medical device manufacturers. Read more here .
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