CE Regulation Service PROLAB Tech Rev 1 Machinery Directive Flow Chart A brief guide

Machine type & Safety Component 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. CE Regulation Service PROLAB Tech Rev 1

Machine type & Safety Component 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. What essential requirement applied to your equipment? Let us help your Assessment headache !! CE Regulation Service PROLAB Tech Rev 1

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

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

Machine type & Safety Component Referred in Annex IV ? 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. CE Regulation Service PROLAB Tech Rev 1

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

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

Machine type & Safety Component Referred in Annex IV ? Comply with relevant standards? Yes 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 CE Regulation Service PROLAB Tech Rev 1

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

Referred to in Annex IV without meeting or only partly meeting the standards, or if no such standard EC type examination thru NB plus Internal check on manufacturing Progress Full Quality Assurance System certified thru Notified Body 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 CE Regulation Service PROLAB Tech Rev 1

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

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

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

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