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14,953 results

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Notification of a Post-Market Clinical Follow-up investigation in accordance with Article 74(1) of Regulation (EU) 2017/745 (MDR) Date: 17. August 2022 Topics: Medical devices Type: Article

According to Article 74(1) MDR, a Post-Market Clinical Follow-up investigation (PMCF investigation) is a clinical investigation conducted after the medical device has been placed on the market for the purpose of further assessment of that device.

Temporary Halt, Early Termination or End of a Clinical Investigation Date: 17. August 2022 Topics: Medical devices Type: Article

If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform the Member State.

Frequently Asked Questions (FAQ) Date: 17. August 2022 Topics: Medical devices Type: Article

Here you will find answers to frequently asked questions about clinical investigations and performance studies.

How is the index to be designed to meet the relevant Essential Safety and Performance Requirements? Date: 17. August 2022 Topics: Medical devices Type: FAQ

We recommend that a tabular list be drawn up, arranged in the rows following the Essential Safety and Performance Requirements set out in Annex I to Regulation (EU) 2017/745 (MDR) or Annex I to Regulation (EU) 2017/746 (IVDR). The list should contain …

Is it possible for a sponsor based in Switzerland or Turkey to submit an application? Date: 17. August 2022 Topics: Medical devices Type: FAQ

No. According to Article 62 (2) and (4) (c) MDR or Article 58 (4) and (5) (c) IVDR, the sponsor, if not established in the Union, must appoint a legal representative in the Union. Neither Switzerland nor Turkey is a member of the EU or a contracting …

Urgent Field Safety Notice for Percutaneous dilator set by Coloplast A/S PDF, 106KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 19440/22

Urgent Field Safety Notice for Dimension Vista CA 15-3 Flex reagent cartride by Siemens Healthcare Diagnostics Inc. Newark PDF, 334KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 18244/22

Urgent Field Safety Notice for LM150TD by Löwenstein Medical Technology GmbH + Co. KG PDF, 612KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 20875/22

Urgent Field Safety Notice for Obstetric suction cup/Geburtshilfe-Saugnapf by Beijing HangTian KaDi Technology R&D Institute PDF, 659KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 20470/22

Urgent Field Safety Notice for Technomed - Disposable Subdermal Needle Electrode by Technomed Europe PDF, 272KB, File does not meet accessibility standards Date: 16. August 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 19863/22

Urgent Field Safety Notice for Roadrunner PC and UniGlide Hydrophilic Wire Guide by Cook Incorporated PDF, 806KB, File does not meet accessibility standards Date: 15. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 18079/22

Urgent Field Safety Notice for V-MAX² Pushing and braking aid by AAT Alber Antriebstechnik GmbH PDF, 79KB, File does not meet accessibility standards Date: 15. August 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 20179/22

Urgent Field Safety Notice for Original-Perfusorleitung PE 200 cm by B. Braun Melsungen AG PDF, 537KB, File does not meet accessibility standards Date: 11. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 18746/22

Urgent Field Safety Notice for Vollsilikonkatheter Nelaton integral by Haiyan Kangyuan Medical Instrument CO. PDF, 76KB, File does not meet accessibility standards Date: 11. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 17777/22

Urgent Field Safety Notice for BEWATEC.Wandarm 500 plus by Wilfried Krömker Medizintechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 19054/22

Urgent Field Safety Notice for myoncare by ONCARE GmbH PDF, 368KB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 19699/22

Urgent Field Safety Notice for IP2000K by Tricumed Medizintechnik GmbH PDF, 296KB, File does not meet accessibility standards Date: 10. August 2022 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 18809/22

Urgent Field Safety Notice for Leica Biosystems Tissue processor by Leica Biosystems Nussloch GmbH PDF, 3MB, File does not meet accessibility standards Date: 08. August 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 12657/22

Field Corrective Actions Date: 05. August 2022 Topics: Medical devices Type: Article

Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use.

Urgent Field Safety Notice for Infusomat Space by B. Braun Melsungen AG, Sparte Hospital Care PDF, 514KB, File does not meet accessibility standards Date: 03. August 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 24012/21