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Re Emergo Europe Molenstraat 15 2513 BH, The Hague Netherlands EU Representative Leisegang Feinmechanik Optik GmbH Leitnizstrasse 32 D-10625 Berlin Germany EU Representative Origio a/s Knardrupvej 2 2760 M l v Denmark Aseptic Processing EU Representative Manufacture Page 1 of 2 Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road,.

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What is an EC-certificate. One of the stages of obtaining approval of a medical device or in vitro diagnostic medical device in Europe is an audit for compliance with the requirements of the European legislation.

The EC DoC is a document which may be required to accompany a product. In the document the manufacturer, or his authorised representative within the EEA should: indicate that the product meets all the necessary requirements of the directives applicable to the specific product.

Full Quality Assurance System. The full quality assurance system conformity assessment is one of the more common assessments used. It includes a full review of your entire quality management system — design, manufacturing, and final inspection.

It is a EC declaration of conformity. A CE declaration does not exist formally. However, a product consists of the product itself, a User manual and an EC declaration of conformity. In general, the EC declaration of conformity is also called a CE Statement or CE certificate.

A EU Declaration of Conformity (also called a CE Certificate, EC Declaration of Conformity, or CE Declaration of Conformity) is the document confirming that the product complies with the applicable CE marking directives or regulations.

The certificate is only part of the CE-marking process We can say that the procedure for passing the audit by the notified body and obtaining the EC-certificate is the final check of what the manufacturer has done before in order to achieve compliance with European regulatory requirements.

You can continue to use the CE marking for goods placed on the market in Great Britain until 1 January 2023. The UKCA marking must be used for placing goods on the market in Great Britain from 1 January 2023.

CE marking documents that the medical device complies with applicable EU legislation. The purpose of the CE marking is to be able to freely market medical devices in the EU, provided that the devices meet any national requirements (such as registration and language requirements).

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© Copyright 1997-2025
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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
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