Regulatory Newsletter Edition 7
?? Welcome to the seventh edition of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory landscape! From up-and-coming trends to analysis, our team of industry experts comb through content around the globe to deliver the most pertinent issues in your industry.
So what's been happening in the regulatory sphere this past month? Grab a hot drink of your choice, sit back and check out the latest news. ? Don’t forget to share with a friend if you found it helpful, and subscribe to make sure you never miss an edition!
FDA
The FDA has announced plans to establish a Digital Health Advisory Committee. The role of the committee will be "to support safe and effective regulation of digital health technologies while encouraging innovation". The committee will be made up of 9 people and applications for membership are being accepted until December 11th.
FDA has released final guidance on 'Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring'. This guidance was initially issued at the start of the Covid-19 pandemic, in March 2020 to facilitate patient monitoring without the need for physical contact between a patient and their healthcare provider. The FDA has determined that this policy has introduced benefits that can continue beyond the initial expiration date for most of the applicable devices. They will continue to monitor the situation and make further updates as needed.
Final guidance on the 'Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions' has been released by the FDA. The draft version of this guidance was initially released in response to the COVID-19 pandemic but continued maintenance of the guidance is consistent with the FDA's least burdensome policy. The scope is limited to changes made to address manufacturing limitations or supply chain challenges.
A list has been released by the FDA outlining the guidance documents that CDRH propose to publish during 2024. The list is broken down into three categories:
The full list of documents can be reviewed here.
The FDA has updated their MAUDE and openFDA databases to include additional patient demographic fields:
This enhancement is intended to make adverse event reports more informative for the public.
EU
A new MDCG guidance document (MDCG 2023-4) has been released - Medical Device Software (MDSW) - Hardware Combinations. This document applies MDSW that is intended to work with either hardware or hardware components, and outlines the regulatory considerations and options for placing these devices on the market.
Team NB has issued a press release calling for IVD manufacturers to submit their IVDR applications without delay. If applications are made in good time, Team NB has confirmed that there are resources available to complete conformity assessment activities ahead of the deadlines, but no guarantees can be made for later submissions.
Particular attention is called to Class D devices, which have a deadline of 26th May 2025, and manufacturers of these devices are encouraged to complete their submissions by the end of 2023 at the latest.
领英推荐
The 12th notified body has been designated under IVDR - Sertio Oy, Finland (#3018).
The 40th notified body has been designated under MDR - Notice Belgelendirme, Turkey (#2764).
Following a request from the MDCG, the European Medicines Agency has released advice on SARS-CoV-2 neutralizing antibodies. This paper addresses the MDCG question on whether a binding assay can claim to detect neutralizing antibodies, and what performance studies should be considered to support associated claims.
The European Commission has released an updated draft timeline for EUDAMED implementation. The new timeline indicates a delay in the Clinical Investigations and Performance Studies module, with an audit planned between Q4 2026 and Q1 2027. The other five modules will be audited between Q2 2024 - Q3 2026. EUDAMED will officially become mandatory in Q2 2029. It is however a good idea to use modules as they become available.
The European Commission has published a call for evidence related to the rationalisation of reporting requirements in the EU. The aim of this action is to identify any EU reporting requirements that could be removed, rationalised, or simplified with the overall goal of reducing reporting burdens by 25% without undermining policy objectives. Feedback is open until 18th November 2023.
In other news
FDA, Health Canada, and the MHRA have joined forces to identify five guiding principles for predetermined change control plans (PCCPs). These principles are based upon the previously established 10 GMLP guiding principles, identified in 2021. The principles are summarised as being:
1. Focused and Bounded
2. Risk-based
3. Evidence-based
4. Transparent
5. Total Product Lifecycle Perspective
More detail can be found here.
Our team is here for you, every step of the way
Keeping up with the changing regulatory landscape can feel overwhelming – but it doesn’t have to be. We provide unrivalled consultancy services to support you in bringing and sustaining your medical devices on the market.
Ready to see how Trinzo can help you? Book your free consultation with one of our expert consultants?here.