The week of 21–27 September 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers developments across WHO medical device prequalification, FDA guidance on robotically-assisted surgical devices, FDA advisory committee activity on multi-cancer detection IVDs, EU health technology assessment and the MDR Clinical Evaluation Consultation Procedure.
In this issue
- WHO expands prequalification programme for medical devices
- FDA issues draft guidance on premarket submissions for robotically-assisted surgical devices
- FDA advisory panel reviews PMA for Galleri multi-cancer detection IVD
- European Commission opens new Joint Scientific Consultation request period
- EU publishes CECP expert decision and opinion on Class III orthopaedic device
WHO Expands Prequalification Programme for Medical Devices
On 25 September 2026, the World Health Organization announced an expansion of its prequalification programme for medical devices.
The expansion adds male and female condoms, intrauterine devices, or IUDs, and computer-aided detection software for tuberculosis screening, or CAD-TB, to the programme.
Male circumcision devices are also being integrated into WHO’s broader medical device prequalification framework.
Prequalification of condoms and IUDs is being transferred from UNFPA to WHO.
The programme also brings CAD-TB software into WHO’s medical device prequalification framework. CAD-TB software uses digital chest X-rays and artificial intelligence to identify people who may require further tuberculosis testing.
The expansion brings additional device categories, including an AI-based screening technology, within a WHO programme used to support international procurement decisions.
Source: WHO
Reference: WHO announces expansion of prequalification programme for medical devices, WHO
FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices
On 25 September 2026, FDA published the draft guidance Robotically-Assisted Surgical Devices — Premarket Submissions.
The document covers certain teleoperated, software-controlled systems used to assist practitioners during open, minimally invasive or endoluminal procedures.
This draft guidance provides recommendations on non-clinical testing, clinical data and labelling for premarket submissions involving these devices.
The document is marked Draft — Not for Implementation.
Comments are due by 24 November 2026.
The draft sets out FDA’s current thinking for premarket review of a rapidly developing category of software-controlled surgical devices.
Source: FDA
Reference: Robotically-Assisted Surgical Devices — Premarket Submissions, FDA
FDA Advisory Panel Reviews PMA for Galleri Multi-Cancer Detection IVD
FDA’s Molecular and Clinical Genetics Panel met on 23 September 2026 to consider the PMA application for GRAIL’s Galleri test.
The prescription-only, NGS-based IVD is intended to detect cancer-specific methylation patterns in cell-free DNA for screening of multiple cancer types in adults aged 50 years or older.
The panel voted 10–0 that there was reasonable assurance of safety, 6–4 on reasonable assurance of effectiveness, and 7–2 with one abstention that the benefits outweighed the risks under the proposed indication.
Panel members also discussed variability in performance across cancer types and questioned whether the term “early” was sufficiently supported for the proposed broad early-detection indication.
The panel recommended clear labelling and further data collection, including longer-term follow-up and additional evidence on real-world performance and patient outcomes.
Advisory committee recommendations are non-binding, and the vote does not constitute FDA approval of the PMA.
The meeting provides a recent regulatory reference point for the emerging category of multi-cancer detection IVDs.
Source: FDA
Reference: Molecular and Clinical Genetics Panel — 24 Hour Summary, 23 September 2026, FDA
European Commission Opens New Joint Scientific Consultation Request Period
On 23 September 2026, the European Commission opened the fourth 2026 request period for Joint Scientific Consultations, or JSCs.
The submission window runs until 21 October 2026 and includes eligible medicinal products, Class IIb and Class III medical devices, and Class D IVDs.
JSCs enable health technology developers to obtain scientific consultation during the planning of clinical studies or investigations on the evidence needs for a potential subsequent Joint Clinical Assessment.
Dedicated templates are available for medical devices, IVDs and parallel HTACG/Expert Panel consultations.
The new request period marks another operational step in the implementation of the EU Health Technology Assessment framework for medical technologies.
Source: European Commission / HTACG
Reference: Joint Scientific Consultations, European Commission
EU Publishes CECP Expert Decision and Opinion on Class III Orthopaedic Device
On 22 September 2026, the European Commission published an expert decision and scientific opinion under the Clinical Evaluation Consultation Procedure, or CECP, for a Class III resorbable filling and reconstruction device intended for intra-articular injection in patients with mild-to-moderate knee osteoarthritis.
The underlying scientific opinion is dated 8 May 2026.
The expert panel considered the notified body’s assessment of the clinical evaluation to be thorough, structured and well documented.
However, the panel found the critical appraisal of the manufacturer’s clinical claims insufficient.
The panel identified methodological issues in the pivotal investigation, considered two promotional claims unsupported by clinical data and recommended additional post-market data collection.
Recommendations included strengthened post-market clinical follow-up and further characterisation of the potential risk of foreign-body synovitis.
The CECP forms an additional element of conformity assessment for certain high-risk devices under Article 54 MDR and Annex IX, Section 5.1.
The published opinion relates to the specific dossier and does not itself indicate the final certification status of the device.
This opinion provides a recent example of how MDR expert panels are assessing clinical evidence, product claims and PMCF within the CECP.
Source: European Commission / Medical Device Expert Panels
Reference: Expert decision and opinion, CECP-EMA/EX/0000335537 — Orthopaedics, traumatology, rehabilitation, rheumatology, European Commission
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