The document outlines the requirements and processes for affixing the CE mark under the EU's 'new approach' directives, detailing various conformity assessment modules (A through H) and the necessary involvement of notified bodies. It emphasizes the importance of the manufacturer's declaration of conformity and the required technical documentation for compliance. Additionally, the author, Jeff Tuthill, shares his extensive experience in technical compliance and conformity assessment within the EU framework.

2. EU “New Approach” Directives – Affixing CE Mark – Conformity Assessment – Manufacturer’s Declaration of Conformity Conformity Assessment Modules A thru H Technical File and 3 rd Party (Notified Body) Attestation

3. Affixing CE Mark to Product is declaring compliance to the Essential Requirements of the Directive(s) Manufacturer’s Declaration of Conformity must be provided Regulated Directives require Notified Body involvement for affixing the CE Mark

4. A. (Internal production control ) D. (Production quality assurance) B. (Type examination) G. (Unit verification) H. (Full quality assurance) Notified Body - Does surveillance To quality system - Verifies conformity of design - Issues EC examination certificate of design Aa Notified Body Specific tests to products Product random verifications C. (Conformity to type) E. (Product quality assurance) F. (Product verification) - Specific tests to products - Product random verifications Notified Body Notified Body - Approves QS - QS surveillance Notified Body - Approves QS - QS surveillance Notified Body - Verifies conformity - Issues certificate of conformity - Verifies conformity with essential requirements - Issues certificate of conformity Notified Body - QS surveillance Notified Body Manufacturer Submits technical documentation OVERVIEW OF CONFORMITY ASSESSMENT MODULES D E S I G N P R O D U C T I O N 1 1 1 1 1 Notified Body - Assures conformity to essential requirements - Does testing, if necessary - Issues CE Type Examination Certificate ISO 17020 (+requirements of ISO 17025 for tests), or ISO Guide 65 (+requirements of ISO 17025 for tests) 1ª and 2ª options EN45001 (+capacity to Decide on conformity) or EN 45004 (+follows Requiremnets of EN 45001for testing) or EN 45011 (+follows Requirements of EN 45001 for testing 1ª and 2ª options: EN45001 (+ capacity to Decide on conformity ) or EN 45004 (+ follows Requiremnets of EN 45001for testing ), or EN 45011 (+ follows Requirements of EN 45001 for testing) EN 45012 (+knowledge of product) EN 45012 (+ knowledge of product) H EN 45012 (+knowledge Of product) Hbis EN 45012 (+ knowledge of product) and EN 45004, or EN 45011 EN 45001 (+ (+ capacity to Decide on conformity), or EN 45004 (+ follows Requiremnets of EN 45001for testing), or EN 45011 (+ follows Requiremnets of EN 45001for testing) EN 45004 (+ follows Requiremnets of EN 45001for testing) or EN 45011 (+ follows Requiremnets of EN 45001for testing)

5. Module A – Internal Production Control (Notified Body [NB] Not Required) Module Aa – Same as above + Tests under responsibility of NB Module B – EC Type-Examination: Responsibility of NB Module C – Conformity to Type: NB Not Required, but must be used with Module B) Module D – Production Quality Assurance: Used with Module B, Responsibility of NB Module E – Product Quality Assurance : Used with Module B, Responsibility of NB

6. Module F – Verification of Product: Used with Module B, Responsibility of NB Module G – Unit Verification: Covers design and production. Each product is examined individually by the NB that issues a conformity certificate. Module H – Full Quality Assurance: Covers design and production. NB certifies ISO 9001, final inspection of product and testing

7. Declaration of Conformity and, where applicable, the Certificate of Conformity must cover individual or several products and shall either go with product or be kept with manufacturer. Module C is to be used with module B (EC type examination). Modules D, E and F may be used on their own. Module H is the most viable for affixing the CE Mark in most cases , if the Manufacturer is implementing, or has an ISO 9001 quality management system.

8. Author’s Bio – Jeff Tuthill, Sr. Associate Engineer with Underwriters Laboratories for ITE U.S. Managing Technical Consultant for the National Standards Authority of Ireland (NSAI) - Learned Rules on affixing CE Mark per “New Approach” Directives - Learned of the European approach to Conformity Assessment and Testing - Received ISO 9001 Lead Auditor Training & audited for Firm Registrations EU Technical Compliance Consultant - Provided ISO Awareness training and EU Compliance Seminars - Took ten US Firms through ISO 9001 QMS Registration process Sr. Compliance Engineer with TUV Essen - Provided IEC testing, CE Mark investigations and GS Certification services - Worked with IEC 1010, IEC 60950, IEC 60601-1, etc. and the European Norms (EN) - Evaluated and verified Technical Files and Design Dossiers for compliance with EU Directives Technical Advisor to the US National Committee (USNC) of IEC for the following - TC (Technical Committee) 62 for IEC 60601-1 Safety of Medical Electrical Equipment - TC 66 for IEC 61010-1 Safety of electrical equipment for measurement, control, and laboratory use - TC 74 for IEC 60950 Safety of Information Technology Equipment