New EU Commission Guidance Published: ‘Q&A on the Gradual Rollout of EUDAMED’
22 November 2024
MDCG 2024-16: MDR/IVDR Article 10(a) Manufacturer Form to Report Supply Disruptions
6 December 2024Below is an overview of the November news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the UK MHRA’s new open consultation on proposed regulatory changes, the EU Commission’s Q&A on the EUDAMED gradual rollout, and more.
Updates from Team Notified Body (NB)
Team NB Questionnaire: Artificial Intelligence (AI) in Medical Devices
Team NB and the German Notified Bodies Alliance for Medical Devices jointly published a new questionnaire on devices incorporating AI. It is available: HERE
The purpose of the document is to help develop common guidance for manufacturers. And should be used as a “reference to best practice”. The reason for its issuance is:
“Practice has shown that it is difficult for manufacturers to sufficiently prove conformity for AI devices, which update the underlying models using in-field self-learning mechanisms. Currently, notified bodies do not consider medical devices based on such models to be “certifiable”, unless the manufacturer takes measures to ensure the safe operation of the device within the scope of the validation described in the technical documentation.”
“Therefore, this guideline is intended to provide AI-specific action guidance in demonstrating conformity.”
Note that the questionnaire is:
- Specific to the MDR/IVDR and MDCG guidance on Medical Device Software (MDSW), i.e., it does not consider specific requirements from the Artificial Intelligence Regulation (AI Regulation (EU) 2024/1689). However, those will be part of a comprehensive revision, to follow.
- Focused on the processes and phases of the life cycle, as opposed to specific requirements for products.
High-Level Position on the Regulatory Framework for the Device Sector
Team NB’s position is available: HERE
They propose items such as:
- Maintaining the 5-year recertification process of medical devices. However, re-certification decisions should focus on new aspects, safety aspects linked to post-market surveillance, vigilance and market surveillance, and be proportionate to the class of the risk (rather than a full repetition of the initial assessment).
- Establishing a new MDCG Working Group (WG) dedicated to “Special Pathways”, consisting of representatives from Competent Authorities:
- The WG would make decisions on devices for which there is a ‘gap’ between the clinical data required by MDR/IVDR and the clinical data the manufacturer can provide pre-market, e.g. devices for special populations and innovative devices.
- Notified Bodies would perform conformity assessment activities, but would not issue a certificate. Instead, they would draft a pre-certification report with an analysis of which data are missing for full MDR/IVDR compliance, and a recommendation on how these data gaps could be filled post-market (e.g. PMCF, PMPF).
- The MDCG “Special Pathways” WG would review the “Notified Body Pre-certification Report” (working title), including potential amendments of the NB’s suggestions for post-market data-collection, and issue a binding opinion.
- Each Member State would have the right to appoint one member and one alternate to the MDCG “Special Pathways” WG.
New/Revised Guidance
MDCG 2024-14: Implementing Master UDI-DI for Contact Lenses
MDCG 2024-14 can be found: HERE
The purpose of the Master UDI-DI is to group devices together that have a high-level of individualization, in order to reduce the number of entries made into the EUDAMED device registration system.
Commission Delegated Regulation (EU) 2023/2197, published October 2023, provided for this possibility. And now MDCG 2024-14 provides further guidance. For example, the hierarchy:
MDCG 2024-15: Publication of clinical investigation reports & summaries pending EUDAMED
MDCG 2024-15 can be found: HERE
It provides guidance on how:
- Sponsors should provide clinical investigation reports and their summaries
- Competent Authorities should label them
- Member States should transit them
- The Commission should (after verifying it is not a duplicate and it is per MDR Article 62 and 74(1)) save and store them
EU Expert Panel: IVD Performance Evaluation Results
The Expert Panel document, in the context of the Performance Evaluation Consultation Procedure (PECP), is available: HERE
The device assessed was intended for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids which includes the Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
IMDRF Essential Principles of Safety & Performance Workshop
On 11 & 19 September 2024, the IMDRF organized a two-part workshop focused on building Medical Device National Regulatory Authority (NRA) capacities and awareness of the IMDRF Essential Principles of Safety & Performance. The workshop targeted current and prospective IMDRF Affiliate Members.
The recordings and materials shared during the sessions are available: HERE
Swissmedic Updates Clinical Investigation and Performance Evaluation Forms
The new forms are available: HERE
MDR/IVDR Transition & Availability of Devices
The EU Commission’s updated Notified Body survey on the MDR/IVDR transition progress is available: HERE
Further, the Commission’s dashboard has also been updated.
This survey was commissioned to support monitoring of the continued availability of medical devices in Europe. The study duration is: December 2022 – December 2025.
These results are from the July/August 2024 survey and it provides further comparison between March 2023 to June 2024.
Update on Swiss-EU Negotiations
The Swiss Federal Council’s press release on the progress, is available: HERE
Negotiations are still progressing, with a hope of soon “achieving a convergence of positions”.
That said, once the negotiations conclude, they still need to pass through the Swiss Parliament and the referendum (popular vote) process.
