Medical Device Recalls Europe

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Quality defects and recalls | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls

Rapid alerts and recalls. This content applies to human and veterinary medicines. The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines. Medicinal products with a quality defect …

International Medical Devices Database

https://medicaldevices.icij.org/

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. ... Implant Files is an …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Best Recall Practices Guidelines — Part 1 — Medical …

https://www.sidley.com/en/insights/publications/2021/02/best-recall-practices-guideline--part-1-medical-devices

Best Recall Practices Guidelines — Part 1 — Medical Devices. February 2021. In this first part of a short series of articles about the recall of products in the life sciences sector …

European medical device recalls increase by 11% - Sedgwick

https://www.sedgwick.com/news/2022/european-medical-device-recalls-increase-by-11

LONDON, 16 September 2022 – Sedgwick brand protection published their latest European product recall index report for Q2. Medical device recall increased to …

Medical device European sector spotlight - Sedgwick

https://www.sedgwick.com/brandprotection/industries/medicaldevice/2021-recall-insights-europe

By the numbers: 2021 European medical device recalls. The volume of product recalls in the medical device category rose sharply in 2021 compared to the previous year – up …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

Eudamed2 - European Databank on Medical Devices. Eudamed2 is the European Databank on Medical Devices. Its purpose is to strengthen market surveillance and …

EU Medical Device Vigilance Reporting in Europe - Emergo

https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe

EU medical device adverse incident and FSCA reporting process. These are the basic steps to reporting an incident in Europe: Reference MEDDEV 2.12/1 to determine the …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

Medical Device Recalls. This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or …

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