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CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

Machinery Directive Flow Chart A brief guide. CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1. Machinery Directive covers fully assembled or partial assembled Machines and also safety related components.

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CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

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  1. Machinery Directive Flow Chart A brief guide • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  2. Machinery Directive covers fully assembled or partial assembled Machines and also safety related components. Lot of machines are eligible for internal check by self assessment to the essential Safety, Environment, EMC requirements and Risk Management measures. Manufacturer declare CE conformity according to Machinery Directive. Machine type & Safety Component • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  3. Machinery Directive covers fully assembled or partial assembled Machines and also safety related components. Lot of machines are eligible for internal check by self assessment to the essential Safety, Environment, EMC requirements and Risk Management measures. Manufacturer declare CE conformity according to Machinery Directive. Machine type & Safety Component What essential requirement applied to your equipment? Let us help your Assessment headache !! • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  4. Some machines and components are subject to assessment procedures with a Notified Body. Manufacturer needs to check if machines fall into these categories Referred in Annex IV ? Machine type & Safety Component • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  5. Some machines and components are subject to assessment procedures with a Notified Body. Manufacturer needs to check if machines fall into these categories Referred in Annex IV ? Machine type & Safety Component Machines designed for people moversuch as lifts and those machines with manually loading and unloading are subject to Notified Body involvement . • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  6. Design Review Compliance assessment to essential requirements When not referred in Annex IV Only the machines and safety control components listed in Annex IV are subject to different procedures set out in the Directive. Machines not listed are only subject to internal conformity assessment to the essential requirements. Referred in Annex IV ? Machine type & Safety Component • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  7. Design Review Compliance assessment to essential requirements Formulate Technical File No Referred in Annex IV ? Technical File covers Technical details and detailed assessment reports. We evaluate and test to help manufacturer formulate Technical Files according to Directive Machine type & Safety Component • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  8. Design Review Compliance assessment to essential requirements Formulate Technical File No Referred in Annex IV ? Machine type & Safety Component • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  9. Where a machine or safety control component is referred in the Annex IV, the first step for manufacturer is to verify if they meets those standards that cover all of the relevant essential requirements Referred in Annex IV ? Machine type & Safety Component Yes Comply with relevant standards? • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  10. Non-comply or partly comply with standards, our engineering service will help walk thru Referred in Annex IV ? Machine type & Safety Component Referred to in Annex IV without meeting or only partly meeting the standards, or if no such standard No Yes Comply with Relevant standards? • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  11. Type Exam by Notified Body is not headache with our technical service, 20 years in regulatory fields, we evaluate machine according and prepare Technical File…… Manufacturer in the subject situation has two options EC type examination thru NB plus Internal check on manufacturing Progress Referred to in Annex IV without meeting or only partly meeting the standards, or if no such standard Full Quality Assurance System certified thru Notified Body • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  12. Manufacturer in the subject situation has two options EC type examination thru NB plus Internal check on manufacturing Progress Referred to in Annex IV without meeting or only partly meeting the standards, or if no such standard Full Quality Assurance System certified thru Notified Body Our Engineering staffs are certified and registered ISO and IECEE QA auditors and that’s how we support manufacturers • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  13. You are an experienced designer here’re your routes….. Referred in Annex IV ? Machine type & Safety Component Yes Comply with relevant standards? Yes, it complies with standards • CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  14. Our service also covers technical document preparation, professionally right to the requirements Is’t comply with relevant standards? Partial assembled machine - Technical File Submit to NB reviewing Yes Maker’s choice TF sent for NB Certification of adequacy EC-type examination (Annex VI) Module B CE Regulation Service 1-416-2713985 PROLAB Tech Rev 1

  15. Design Review Compliance verification to essential requirements Formulate Technical File No Referred in Annex IV ? Machine type & Safety Component Referred to in Annex IV without meeting or only partly meeting the standards, or if no such standard No Yes Comply with EN standards? Yes

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