Newly Published: Q&A on Obligation to Inform of Device Interruption or Discontinuation
30 October 2024
MHRA Updates: New Regulation Timing, IVD Roadmap, Transitional Provisions, and more
1 November 2024Below is an overview of the October news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., EU Parliament’s vote to revise the MDR/IVDR, the Q&A on the new obligation to inform of device supply disruption, and more.
Medical Device Coordination Group (MDCG)
MDCG 2024-12: Corrective and preventive action (CAPA) plan assessment
MDCG 2024-12, published 7 October 2024, is available: HERE
This guidance is applicable to Conformity Assessment Bodies (CABs), Notified Bodies (NBs), Designating Authorities (DAs), and Joint Assessment Teams (JATs) involved in MDR/IVDR devices.
It provides guidance for:
- Notified Bodies when establishing CAPAs to address NCs resulting from joint assessments
- Authorities responsible for Notified Bodies, i.e., Designating Bodies, when conducting reviews
- Joint Asssesment Teams when considering the CAPA plan and DA’s opinion thereon
MDCG 2024-13 & MDCG 2022-5 rev.1 on Ethylene Oxide (EtO)
MDCG 2024-13, published 29 October 2024, is available: HERE
The guidance clarifies that EtO used in medical device sterilization is regulated under MDR/IVDR, not under the Biocidal Products Regulation. And ensures that manufacturers and health institutions are aware of their obligations regarding the sterilization process.
MDCG 2022-5, guidance on borderline between medicinal products and medical devices, has been revised due to the above. It was updated to revise Example 1.2.6.1, which cited sterilization by ethylene oxide. MDCG 2022-5 rev.1 is available: HERE
MDCG Vigilance Working group June 2024 Meeting Minutes
The minutes are available: HERE
Items discussed include:
- New Manufacturer Incident Report (MIR) form:
- The updated version of the PDF form will be circulated for final testing. The intent is to publish the form together with the FSN, FSCA, and other reporting files (currently under the MDD section of the Commission website).
- The current MIR PDF 7.2.1. will still be available online on the Commission website for 6-months after the publication of the new MIR PDF 7.3.1, to provide sufficient time for operators to adapt their internal databases.
- Once the EUDAMED vigilance module is fully functional, the MIR PDF should in principle not be used anymore; however, a phasing-in period is likely needed before doing away with the form full-stop.
- A revision of the MIR Q&A document will be required, to reflect specific aspects of the new version.
- Manufacturer Trend Report (MTR):
- Industry organizations shared their disagreement with the current interpretation of manufacturer requirements to be applied for submitting a trend report, as reflected in the draft Q&A document. They committed to preparing a dedicated presentation for discussion at the PMSV Working Group level.
- There was a general agreement on the need to define what information should be required from the initial trend report, to 1) evaluate the risk level and 2) assess the need for corrective actions (CAPAs).
- The proposal from some Competent Authorities to receive trend reports only if they are linked to high risks for patient safety was not agreed upon. Therefore, the submission of a trend report should not be necessarily linked to the submission of an FSCA.
- The outcome of a trend report could be a CAPA or other types of actions (e.g. training of users of the device) or, in some circumstances, there may not be any further action required.
- It was commonly agreed that manufacturers’ corrective actions would be required from the follow-up trend report, and not at the initial one. This is in case an initial trend report turns out to be a false alarm and does not result in a negative change in the risk-benefit ratio. And that, after having provided all relevant explanations through a follow-up trend report, manufacturers would not be required to perform the whole trend report cycle.
- Manufacturer conduct for investigation of serious incidents:
- A draft proposal is being prepared on (1) aspects related to device return, (2) aspects related to manufacturer investigations, (3) how manufacturers should follow up on serious incidents, and (4) communication aspects to Competent Authorities.
- Exemptions from reporting:
- Competent Authorities had outlined that the MDR does not allow for an exemption from reporting serious incidents. The ongoing work now focuses on examples and scenarios where Competent Authorities do not consider events to meet the criteria of serious incidents.
MDCG IVD Working Group Nov 2024 Meeting Agenda
The agenda is available: HERE
Some of the topics to be discussed in the 13 November 2024 meeting include:
- Targeted evaluation of the MDR and IVDR
- Distance Sales
- Definition of a health institution
- Q&A on Performance Studies
- COMBINE Project
EU Commission/Competent Authority
Notified Body (NB) Designation Update
The Commission published an update on the NB designation progress: HERE
Status:
- Total Applications:
- 21 IVDR NBs
- 62 MDR NBs
- Total Currently Designated:
- 50 MDR NBs
- 13 IVDR NBs
Public Consultation: AI Act & Draft Implementing Regulation
It is available: HERE
Purpose of the initiative:
“Summary: The Artificial Intelligence (AI) Act envisages the establishment of a scientific panel of independent experts to advise on, and assist the AI Office and national market surveillance authorities with, implementing and enforcing the AI Act. This initiative sets out rules for the establishment and operation of this scientific panel.”
The draft implementing regulation is available in the above link.
Feedback Period: 18 October 2024 – 15 November 2024 (midnight Brussels time)
Public Consultation: HTA Joint Scientific Consultations
It is available: HERE
The Health Technology Assessment (HTA) regulation helps standardize the clinical assessment of new health technologies (primarily medicines and certain high-risk medical devices), for national reimbursement decision-making purposes.
The HTA regulation also includes Joint Scientific Consultations (JSCs), which allows medical device manufacturers to simultaneously obtain clinical consultations relevant to both their MDR/IVDR and reimbursement applications. And therefore, reduce duplication of work.
Purpose of the initiative:
“Summary: This initiative concerns joint scientific consultations on medical devices. It set outs implementing rules detailing how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product.”
The draft implementing regulation is available in the above link.
Feedback Period: 29 October 2024 – 26 November 2024 (midnight Brussels time)
Team Notified Body (NB)
Team NB Press Release: European Reference Laboratories (EURLs)
It is available: HERE
The document generally covers information already known from the regulation and MDCG guidance documents. That said, it does help provide a clear explanation re: the role of EURLs for Class D IVDs starting 1 October 2024.
Team NB is Now an HTA Stakeholder
The announcement is available: HERE
Please read the section above for more information on the purpose of the Health Technology Assessment (HTA) regulation.
International MD Regulators Forum (IMDRF)
IMDRF: Common Data Set for Adverse Event Data Exchange
The final guidance, published 10 October 2024, is available: HERE
The intended audience are IMDRF country regulators, and how to best share adverse data amongst themselves.
IMDRF: Webinar from 24 October 2024
Previously announced: HERE
The webinar topic was on the open consultation on the new guidance document: ‘Considerations for the Selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers’
The purpose of the guidance is to help industry select the most appropriate adverse event codes, including providing examples of common mistakes.
During the live webinar, the IMDRF advised that the recording would not be made available on its website. This is to prevent confusion, in case there are changes between the webinar and the final guidance. Instead, once the guidance document is published, the IMDRF will provide a training. This training will then be added to the website.
