Update on Timing for Mandatory Use of the ‘swissdamed’ Device Registration Module
2 January 2025
New EU Initiatives: eIFUs for all Professional Use Devices, Reclassification of Certain Devices, and more
7 January 2025Below is an overview of the December 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 2024-2026 Roadmap of Future Regulations, the Commission’s Open Consultation to Evaluate the MDR/IVDR, and more.
Revised MDCG Guidance
MDCG 2019-13 rev. 1
MDCG 2019-13 rev.1, on Notified Body Sampling for MDR Class IIa/IIb & IVDR Class B/C Devices, is available: HERE
A minor update was made to footnote 10:
Red: MDCG 2019-13 (original) / Green: MDCG 2019-13 rev.1
MDCG 2022-3 rev.1
MDCG 2022-3 rev.1, Verification of manufactured Class D IVDs by Notified Bodies, is available: HERE
Examples of the changes are provided below.
The following paragraph added to Section 2:
“It is understood that the IVDR requirements related to testing every product batch, and consequently this guidance document, are relevant for devices for which the concept of batches is applicable. For example, the concept of batches is not applicable for medical device software. Therefore, the corresponding IVDR batch testing requirements and this guidance document are not relevant to class D medical device software.”
Paragraph added on agreements between manufacturers and EURLs in Section 4.1.2:
“The manufacturer may have agreements directly with an EURL for aspects such as logistics of shipment of instruments and samples or responsibility for the equipment, under the oversight of the notified body.”
The following note added under Section 5.3, Table 3:
“Note: Calibrators and controls placed on the market separately should follow the testing frequency of the corresponding device(s)/reagent(s). Device/reagent-specific controls placed on the market separately and intended for use with IVDs falling in the first indent of rule 1 in Annex VIII of the IVDR may follow the adjustable testing frequency set out in the second line of Table 2.”
Legislative & Program Updates
Commission adopts rules under the HTA Regulation
The update is available: HERE
On 18 December 2024 the Commission adopted an implementing regulation which sets out the rules for joint scientific consultations under the Health Technology Assessment (HTA) Regulation.
Background: the HTA Regulation (HTAR) helps standardize the clinical assessment of new health technologies (primarily medicines and certain high-risk medical devices), to inform reimbursement decisions. Further, the HTAR establishes a framework for Joint Scientific Consultations (JSCs), which can advise on the clinical evidence needed both to 1) demonstrate value from a health technology assessment and reimbursement perspective, and 2) a regulatory standpoint. I.e., while manufacturers must still work with their Notified Body on clinical evidence for CE Marking, the introduction of JSCs helps manufacturers better align their clinical evidence to include both regulatory and reimbursement expectations, from the start.
EU COMBINE Programme
The update is available: HERE
“National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics.
The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials and medical devices, as well as the Commission, European Medicines Agency, ethics committees and stakeholders such as sponsors, clinicians, and patient representatives.
Among the goals of this programme are to:
- Pilot a single assessment process for multi-country combined studies across device and medicinal product regulations
- Harmonise serious adverse event reporting processes
- Clarify questions on the interface between clinical trials and medical device regulations
- Explore new opportunities for advising sponsors and facilitating knowledge exchange among national authorities”
MHRA AI Airlock Pilot Program
The update is available: HERE
The MHRA announced the five technologies selected for the pilot program, such as the below two devices:
“OncoFlow uses AI to help healthcare professionals in the cancer care pathway create personalised management plans for cancer patients. This has the potential to reduce waiting times for cancer appointments, leading to earlier treatment which in turn significantly increases the chances of survival. Initially, OncoFlow will focus on breast cancer patients due to the high number of cases and waiting times. However, the platform can be adapted for other types of cancer in the future.”
“Clinical guidelines contain lots of information about how best to treat patients, but trawling through all these websites and documents is time consuming. SmartGuideline is an AI agent that uses curated knowledge graphs with RAG [Retrieval-augmented generation], on a database of National Institute of Health and Care Excellence (NICE) resources (guidelines, clinical knowledge summaries, patient information leaflets and the British National Formulary). Clinicians can ask a clinical management question and receive a response in natural language, with a citation to the reference document from which the response came. If there is not enough information, the agent will not output a response. The product can suggest best treatment options, investigations, red flags and referral criteria, and warn of potential drug interactions. The AI Airlock would like to investigate the regulatory advantages of using RAG with verified knowledge bases and LLMs [large language models].”
Background: This is the “MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products”. The intent of the program is to use real-world products to help guide future guidance and policy.
Team Notified Body Updates
Position Paper: MDR Certification Process
The Position Paper is available: HERE
Team NB’s guidance outlines the steps at each phase of the certification process and offers insights into Notified Bodies’ expectations. It is applicable for both legacy devices and devices newly entering the market.
Key Highlights
Pre-Application Phase:
- Initial contact and submission of pre-application information to confirm MDR applicability and device classification.
- NB reviews details and provides a quotation based on submitted data.
Application Phase:
- Formal application, including required documentation for Quality Management System (QMS) and specific device details.
- Review by NB to ensure completeness, correct classification, and applicable conformity assessment procedures.
- Written agreement/contract between the manufacturer and NB.
Conformity Assessment:
- Includes audits, technical documentation assessments, and product testing based on device classification (e.g., Class I, IIa, IIb, III).
- Specialized consultations may apply for devices with specific characteristics (e.g., devices with medicinal substances or animal tissue).
Final Review and Decision:
- NB assesses all documentation and audit findings before deciding on certification.
- Includes evaluation of post-market surveillance plans and conditions for certification.
Post-Certification:
- Surveillance audits, technical documentation sampling, vigilance data review, and unannounced audits ensure ongoing compliance.
Appendix (starting page 12):
- Detailed list of data/documents required at various stages.
Press Release: Revised Code of Conduct
The Press Release is available: HERE
Team NB has adopted version 5 of its Code of Conduct, which was published on its website on 16 September 2024.
Key updates include the removal of Directive references, alignment with MDCG and other guidance, clear timelines for technical documentation reviews and audits, re-certification requirements, CAPA estimations, structured dialogue examples, and an updated enforcement process using complaints/appeals.
Members are required to sign the new version in order to remain a part of Team NB. Version 5 was endorsed by 42 of the 44 members.
Press Release: Update on Implementation of Class D oversight by EURLs
The Press Release is available: HERE
Team NB has made significant progress in implementing oversight for Class D devices under the IVDR through collaboration with European Reference Laboratories (EURLs). This includes endorsing a standardized Multi Services Agreement template, to ensure compliance with EU regulations.
