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  • Orkla Care Declaration Of Conformity Procedure Pack 2016

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DECLARATION OF CONFORMITY PROCEDURE PACK This is a declaration made in accordance with the requirements in Article 12 of the Medical device directive 93/42/EEC including amendments to date as implemented.

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How to obtain CE marking? As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must: ensure conformity with all relevant EU-wide requirements.

Sometimes a Declaration of Conformity is referred to as a CE Statement or CE certificate. This is because the DoC is the official document that states that a product meets all EU health and safety requirements and can therefore legally bear the CE mark.

A Declaration of Conformity (DoC) is a required self-certifying document created by the medical device manufacturer to state that a device or a series of devices complies with the conformity requirements of a particular country's regulations.

A Quality Management System based on ISO 13485 helps to meet most of these review routes. 5) Declaration of conformity: This is the last step in which the supplier of the medical device confirms that the device fulfills all obligations identified in the relevant directives.

What does a Declaration of Conformity mean? It is a formal declaration by a manufacturer, or the manufacturer's representative, that the product to which it applies meets all relevant requirements of all product safety directives applicable to that product.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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:
1-877-389-0141
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