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  • Medical Device Adverse Incident Report Form Hip Or Knee Implants - Mhra Gov

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Medical device adverse incident report form Hip or knee implants Reporter details Name Organisation Address Tel E-mail Consultant-in-charge (if known) Local reference number This report confirms a.

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Medical devices are divided into four classes in the UK, in ance with the UK Medical Device Regulations 2002,generally based on the intended purpose of the device, how long it's intended to be used and how invasive it is: Class I: low-risk devices like wheelchairs or stethoscopes.

General medical devices and active implantable devices Class I - generally regarded as low risk. Class IIa - generally regarded as medium risk. Class IIb - generally regarded as medium risk. Class III - generally regarded as high risk.

The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

The higher the class of the device, the greater the involvement of a notified body in conformity assessment. Annex I (general safety and performance requirements) and Annexes II (technical documentation) and III (technical documentation on post-market surveillance) apply to all devices regardless of class.

ing to MEDDEV 2.12/1, an incident report must be filed if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death or serious injury or may lead to death or serious deterioration in the state of health if it were to recur.

For general enquiries about adverse incidents involving medical devices contact our Adverse Incident Centre: aic@mhra.gsi.gov.uk or 020 3080 7080. Each devolved administration has its own guidance on reporting adverse incidents, available on the respective websites.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232