Gap Analysis Please provide us with the data we need to provide you with an overview of your company's CE marking responsibilities, as well as advise which steps to take to obtain the CE marking for your products. Your Name*(First Name, Last Name) First Last Email*Please provide the email address to which we can send the report. Type of Economic OperatorWhat type of economic operator is your company in relation to the product that you are interested to have CE marked?-Select-ManufacturerImporterDistributorOtherManufacturerIntended PurposeHas the 'intended purpose' of the product been formulated and written down? Yes No Don't Know Applicable CE Directive(s)Has your company determined which CE marking directive(s) applies/apply to the product? Yes No Don't Know Applicable StandardsHas your company determined which European harmonized standards apply to the product? Yes No Don't Know Applicable Classification and CA RouteHas your company determined in which category or class your products fall (where relevant), and which conformity assessment route must be followed? Yes No Don't Know Applicable Essential RequirementsHas your company identified which essential requirements of the relevant CE directive(s) are applicable? Yes No Don't Know Applicable Requirements From StandardsHas your company identified which requirements in the European harmonized standards are applicable? Yes No Don't Know Conformity AssessmentHas your company conducted (or has a third party conducted) the conformity assessment against the requirements of the directive(s) and standards? Self-Assessment Third Party Assessment No Self-AssessmentHas the conformity assessment been documented? Yes No Don't Know Test Report/CertificateHave you received a (test) report and certificate from the third party? Yes No Don't Know Technical FileHas your company drawn up a Technical File for the product(s)? Yes No Don't Know Technical File StoragePlease decribe where and how is your products' Technical Files are stored?Technical File Storage SystemHas your company a system in place that ensures that Technical Files are stored for at least 10 years after the last product of a type is placed on the market? Yes No Don't Know Authorized Representative or SPCHas your company appointed an "Authorised Representative" or a 'single point of contact'? Yes No Don't Know Declaration of ConformityHas your company drawn up a EU Declaration of Conformity (in CPR Declaration of Performance) for the product? Yes No Don't Know CE MarkingHas the CE marking been affixed to the product or to the packaging? Yes No Don't Know Name and AddressDoes the product label contain your company’s (trade)name and postal address? Yes No Don't Know Batch/Serial/Type NumberDoes the product label contain a type, batch or serial number or other element allowing its identification? Yes No Don't Know User ManualIs a users manual or safety instructions made and supplied with the product? Yes No Don't Know Product StorageDoes the product require particular storage and transport conditions? Yes No Don't Know Serial ProductionIs your product produced in serial production? Yes No ImporterQuality SystemDoes your company have a (certified or non-certified) quality management or quality control system? Yes No Don't Know CE KnowledgeWithin your company, is there knowledge about the CE marking directive(s) and standards that apply to its products? Yes No Don't Know Conformity AssessmentHas your company ensured the appropriate conformity assessment procedure has been carried out by the manufacturer? Yes No Don't Know Technical FileHas your company ensured Technical File has been drawn up and can it be made available when necessary? Yes No Don't Know Conformity MarkingHas the conformity marking (CE Mark and/or other marking) been affixed to the product? Yes No Don't Know Product LabelDoes the product label contain your company’s name/registered trade name and a single point of contact? Yes No Don't Know Type/Batch/Serial NumberDoes the product label contain a Type/Batch/Serial Number? Yes No Don't Know Declaration of ConformityIs your company in the possession of a copy of EC Declaration of Conformity for all CE marked products? Yes No Don't Know User Manual & Safety InstructionsIs the product/are the products accompanied by instructions and safety information in a language easily understood by end-users? Yes No Don't Know Incoming InspectionDoes your company conduct an incoming inspection on products that includes checking for compliance? Yes No Don't Know Procedure For Non-Compliant and Risky ProductsHas your company set up a policy or procedure for cases when a non-conformity of a product is suspected, or when a product is suspected to pose a risk for end users? Yes No Don't Know Complaint HandlingDoes your company have a complaint handling procedure? Yes No Don't Know Storage and Transport ConditionsDoes the product require particular storage and transport conditions? Yes No Don't Know Storage & Transport InstructionsHas you company provided storage and transport instructions to the distributor or end user? Yes No Don't Know DistributorCE KnowledgeWithin your company, is there knowledge about the CE marking directive(s) and standards that apply to its products? Yes No Don't Know Incoming Products' InspectionDoes your company conduct an incoming inspection on products that includes checking for compliance? Yes No Don't Know Procedure For Non-Compliant and Risky ProductsHas your company set up a policy or procedure for cases when a non-conformity of a product is suspected, or when a product is suspected to pose a risk for end users? Yes No Don't Know Conformity MarkingHas the conformity marking (CE Mark and/or other marking) been affixed to the product? Yes No Don't Know Product LabelDoes the product label contain your company’s name/registered trade name and a single point of contact? Yes No Don't Know Type/Batch/Serial NumberDoes the product label contain a Type/Batch/Serial Number? Yes No Don't Know User Manual & Safety InstructionsIs the product/are the products accompanied by instructions and safety information in a language easily understood by end-users? Yes No Don't Know Storage and Transport ConditionsHave you received particular storage and transport conditions? Yes No Don't Know Storage or Transport Conditions Implemented? Yes No Don't Know 'Manufacturer': The manufacturer is any natural or legal person who is responsible for designing or manufacturing a product and places it on the market under his own name or trademark. 'Importer': The importer as the economic operator established in the Union who places a product from a third country on the Union market has important and clearly defined responsibilities under Union harmonisation legislation. 'Distributor': The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. Δ
