The document outlines the 10 steps for the CE marking process: 1) Identify applicable directives, 2) Identify conformity assessment procedures, 3) Determine compliance dates, 4) Identify applicable harmonized standards, 5) Ensure compliance with essential directive requirements, 6) Determine if independent assessment is required, 7) Maintain technical documentation, 8) Prepare declaration of conformity, 9) Check for additional national requirements, and 10) Affix CE marking. It also lists the information that should be included in the technical file to demonstrate compliance.

1. Lakshy Management Consultant Pvt. Ltd.
…aiming excellence
Corporate Office: - 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400 614, India
Phone: +91 22 32995241 E mail: info@lakshy.com Web: www.lakshy.com
The CE marking Process
Step 1: Identify the Directive(s) that are applicable to your product.
Step 2: Identify the conformity assessment procedure that must be taken. This could be self-
declaration, involve testing, inspection or quality system assessment from a Notified Body or a
combination of these. The conformity assessment procedure will differ depending on your product
and the Directive in respect of which you will be CE marking.
Step 3: Determine the dates by which you must take action. This will be the date that the
Directive comes into force. The majority of directives are already in force. In these cases, it is an
offence to place a product on the market without CE marking because it indicates a presumption
of conformity with all relevant Legislation.
Step 4: Identify if there are any Harmonized European Standards applicable to your
product. These are not always mandatory for manufacturers although there is a presumption that
conformity to these standards will give conformity with the relevant part of the Directive. Whenever
possible or appropriate, manufacturers should follow harmonized standards.
Step 5: Ensure the product complies with all the essential requirements of the Directive(s).
Take appropriate measures to comply or identify existing data and test reports.
Step 6: Identify whether independent assessment of your conformity to the Directive, or
some aspects of it, is required from a Notified Body. This will be stated in the directive and is
dependent upon the product you are CE marking. You must not affix CE marking to your product
until all necessary certifications have been obtained from the Notified Body.
Step 7: Maintain Technical Documentation required by the Directive(s). Your technical
documentation should support your compliance with the requirements of the Directive. It is
essential to retain this documentation.
Step 8: Prepare the Declaration of Conformity and the required supporting evidence. The
Declaration of Conformity along with the Technical Documentation should be available to
Competent Authorities (EU Members) upon request.
Step 9: Check that no other purely national requirements exist in the countries where the
product will be sold. These may include national standards, labeling or packaging requirements.
Step 10: Affix CE marking on your product and/or its packaging and accompanying literature
as stated in the directive.

2. Lakshy Management Consultant Pvt. Ltd.
…aiming excellence
Corporate Office: - 232, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400 614, India
Phone: +91 22 32995241 E mail: info@lakshy.com Web: www.lakshy.com
Technical File should include:
• Description of the product family and justification for why each products falls within the
product family
• Detailed account of the Intended Use of the device(s) including where the device is used,
what it is used with and who uses it
• An account of how the device(s) functions and what it actually does
• Description of components, specifications, packaging and literature.
• The manufacturing process
• Listing of accessories
• Location of design responsibility and manufacturing facilities
• Classification of the device and rationale for classification
• The chosen route to compliance according the applicable Directives
• Declaration of Conformity that states manufacturers' compliance with applicable
Directive(s)
• Lifetime/shelf life of products and environmental limitations
• Retention of QA, Competent Authority and Notified Body records
• Vigilance reporting and Medical Device Reporting procedure
• How and when to contact Competent Authorities
• Name of, and contract with, your Authorized Representative in Europe
• Subcontractor names and addresses, if applicable
• Essential Requirements
• Design input specifications
• References to Standards and Guidelines
• Testing results and clinical trials (if needed)
• Risk analysis
• Instructions for Use and Labeling
• Compliance or certification to appropriate Quality Management System like ISO 9001 etc.