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.

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.