Materiovigilance: current status, global perspectives and implication for pharmaceutical practice
Bibliographic record
Abstract
Background. Medical devices are essential components of modern healthcare, but their increasing use has heightened the need for structured safety monitoring. Materiovigilance refers to the systematic detection, reporting, and evaluation of adverse events associated with medical devices. While several countries maintain well-established regulatory systems, India formalized its framework through the Materiovigilance Programme of India (MvPI), coordinated by the Indian Pharmacopoeia Commission. Aim. This narrative overview summarizes the global development of materiovigilance systems, describes India’s regulatory framework, and outlines the relevance of medical device safety monitoring to pharmaceutical professionals. Methods. Literature from PubMed, Scopus, regulatory authority websites, and policy documents published between 2015 and 2025 was reviewed to identify national and international approaches to materiovigilance, common challenges, and opportunities for implementation. Results. Countries such as the United States, European Union members, Japan, Australia, and Canada have established post-marketing surveillance systems for medical devices, whereas India’s MvPI is still evolving since the implementation of the Medical Device Rules (MDR) 2017, which categorize devices into four risk-based classes (A–D). Challenges persist in under-reporting, lack of awareness, limited traceability, and uneven institutional integration. Pharmaceutical professionals can contribute to improved materiovigilance through adverse event reporting, device handling oversight, risk communication, and integration of device safety into existing pharmacovigilance workflows. Conclusion. Materiovigilance complements pharmacovigilance and forms an essential part of broader patient safety systems. Strengthening reporting mechanisms, enhancing awareness among healthcare workers, and involving pharmacists in device safety activities can improve the overall effectiveness of materiovigilance initiatives in India and globally.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.036 | 0.078 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.008 | 0.011 |
| Science and technology studies | 0.001 | 0.007 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.003 | 0.005 |
| Research integrity | 0.005 | 0.006 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".