There are many different types of technical documents. Technical file what is it and how to create it ce check. Technical file for ce declaration template or sample of required contents i just completed our technical file tf for a class iib product. Ce marking obtaining the certificate, eu requirements your europe. It also requires manufacturers to prepare an eu declaration of conformity doc demonstrating that they have complied with all their legal obligations. This document provides technical supporting information for the 30 indicators and four chapterspecific callout features that appear in the u. The provisions regarding the ce mark compliances documentation are a part of the new. Ce marking what it means for ppe what is the meaning of a ce mark. We hear quite often that an importer thinks that a product complies because the noneuropean manufacturer has sent. A company ltd technical file no 1234tf1 pressure equipment. Manufacturer a further processes the implant to apply proprietary coating, sterilisation and final packaging.
Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. Information on ce technical file documents for ce mark certification is covered in ce mark total documentation package, provided with free demo by global manager group. Many products require ce marking before they can be sold in the eu. Technical documents download technical documents, including instructions for use, material safety data sheets, specifications, control assay sheets, maintenance logs, and more for ortho clinical diagnostics products. Our devices team has a wealth of experience in obtaining ce marking for ivds and medical devices. Ce mark documents for structural steel is designed and developed to guide steel structure manufacturing companies for ce certification as per din en 1090 part 2 and iso 3834 part 2 requirements. They can assist your company in securing a ce mark. The ce mark above is a symbol that a manufacturer see definition below affixes to a product.
Improving technical documentation key pit falls to avoid in preparing technical documentation itoro udofia, phd. The exact stepbystep system to correctly creating a ce marking technical file get your product approved to sell in the european. For example, the eu directive for products which fall under the. The new approach directives require that the manufacturer compiles technical documentation technical file with information to demonstrate compliance with the applicable requirements.
Climate change indicators in the united states, 2014. As of today the manufacturer has to document by the ce mark as well as the compliance with all applicable requirements laid down in the cpr and in other relevant union harmonization legislation providing for its affixing. These examples are registered with numerous plagiarismchecking services. The technical file must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements.
The ce mark is usually added to the identification plate, the products label, or by placing a sticker on the product itself. You can also see an example of a technical file by clicking here. Technical file for ce declaration template or sample of required contents table of contents section 1. A number of communication documents have been produced to assist you in understanding the various aspects of ce marking, namely. The ce marking is a european proof of conformity and is also described as passport that allows manufacturers and exporters to enter products freely within the eu. For example, if a business wishes to market its products in europe and those products are covered by the relevant eu legislation that prescribes. Medical appssoftware and what to include in the technical. Manufacturer a applies for ce marking for a class iii device a surface coated knee joint replacement. Medical devices guidance document classification of. Usually this document is the universal term of documentation regarding to a product or service and it also explains how a product operates. I wouldnt wait to long to buid a table of context on where the proper documentation can be found. Europe ce marking for medical devices under new mdr. It includes information pertaining to the changes in classification resulting from the amending and implementing directives issued since the last revision of this document in. The thesis commissioner is planning to have an audit for the ce marking in the february of 2016.
Example of a declaration of conformity ce marking assistant. It is kind of like a glossary, just without the definitions. We declare the technical file for this machine was compiled according to appendix vii part b and undertake to forward these to market monitoring authorities by request via our technical department. This document is a revision of an earlier document published in july 2001 as meddev 2. Does anyone have a template or sample of the contents of a technical file to prepare for ce declaration. The ce mark is a symbol that when affixed to a product indicates that it complies with the relevant eu legislation, which enables the free movement of products within the european market. Only in exceptional cases, for example for specific dangerous medical devices, large pressure vessels or construction products, is it necessary to consult a notified body which. Industry in europe has brought to the attention of the european commission that they support the selfcertification of safe products with the ce mark, and their opinion that third party notified body certification not become mandatory but be. Technical documentation esrs for ce marking of pressure equipment. Ce marking principles device classification medical device directive mdd in vitro diagnostic device directive ivmdd active implantable medical device directive aimdd 200747ec amending mdd and aimdd globally harmonized technical file and design dossier declaration of conformity clinical evaluation postmarket requirements. Usually, each part of the technical file of your product can consist of more than one document. The information given in the technical files are structured as per mdr and ivdr. Example of a declaration of conformity generated through the ce marking assistant web application producing a declaration is one of the integral tasks involved in ce marking a product or machine.
Are you bringing a medical device onto the european market. Machinery directive technical files ce mark consultancy ce. Dublin road, ballybrittas co laoise ireland contact. The product has the ce mark applied to the labelling. Guidance on technical documentation for ce marking the eucert assists manufacturers, importers, and distributors on a regular basis with the technical documentation requirements. The documentation shall make it possible to assess the products conformity to the relevant requirements and shall include an adequate analysis and assessment of the risks. Learn the basics on technical files with our helpful guidance.
You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. Document control revision description author approved by date 1. When you, as the manufacturer, affix the ce marking to a product it means. It is a legal obligation of the manufacturer to ensure that the technical documentation is drawn up and up to date. Which technical document you choose to create depends on your audience and your purpose. Ce technical documentation by global manager group issuu. Technical documentation overview copy quest global. Technical documentation read technical file the manufacturer shall establish the technical documenta tion. The banner marking is found at the top of the docum\. The following are links to the examples and models of the kinds reports, letters, and other documents discussed in this book. Ce marking is selfcertification, which is particularly good for small and medium companies. The entire documentation kit has 46 chapters as below.
Ce medical can assist you with the composition and drawing up of the technical documentation to. The ce mark is based on the file and if your company is ever challenged you dont want to be scrambling for information. For example, the softwaredevelopment documentation part could contain information about. The technical documentation should include at least. You know how priorities are, before you know there are 5 other things to be done and you lose site of the technical file. White paper eu rohs2 technical documents for ce mark v4. Producing a declaration is one of the integral tasks involved in ce marking a product or machine. Action plan for the trading company and the place of the user manual even if a trading company is not regarded as a manufacturer, it still has its certain responsibilities in the field of the ce marking. Commissioning of the machine is acceptable as it complies with the provisions of all applicable ec directivesthis declaration is invalidated. It is easy to spend too many hours searching the tremendous volume of ce marking related information. Directives, to correct application of the ce mark on your product. Introductions are vital to helping your reader understand the context, purpose and structure of your document. A technical documentation template is any sort of document that explains controlling, utility, ability and design of a technical product. Environmental protection agencys epas report, climate change indicators in the united states, 2014.
Floor tiles are covered by a harmonised standard when used in. Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of ivd medical devices sted study group 1 final document ghtfsg1sg1n063. Thats why i got more and more involved in the ce marking process, risk analysis, technical files and compiling docs before i used the method that i describe in this post, i spent ages on the internet, finding the right information on what to include in the doc and what not. Sample ce technical file documents for ce mark certification.
Manufacturer a applies for ce marking for a class iii device a surface coated knee joint replacement implant the uncoated implant is ce marked by us manufacturer with bsi, and supplied in this manner to manufacturer a. How to create technical documents in word 2016 universalclass. Ce marking is currently required for many products sold in europe, yet many u. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. Technical documentation esrs for ce marking of pressure equipment manufacturer. In decision 90683eec of december 1990 the council established that the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users. Most of the new approach directives impose an obligation for the manufacturer to draw up and to provide technical documentation or a technical file containing certain information to demonstrate the. A pilkington outline of the initial proceduresrequirments to ce mark your products introducing easy steps to ce marking powerpoint presentation. For example, the safety of machinery directive, the electromagnetic. Demo of ce technical file document kit price 399 usd buy. However, the name and address of the person in possession of the file need not be expressly mentioned on the product or on its packaging, unless otherwise specified. The technical file must contain all information that is necessary to demonstrate the conformity of the. The technical file should have two versions, conventionally named part a and part b.
Key words ce, factory production control, construction products regulation, en 1090, hen. Technical documentation, technical construction file, tcf and technical file are all references to the same documentation, but regardless to its official title, it is required in one form or another by all of the ce marking legislation to perform the same task. Demo of ce technical file document kit price 399 usd. Ce marking reference material the web has many good sources of information relating to ce marking. The ce mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized european standard. A information to provide in your technical documentation submission 11 7 technical documentation sections 12 attachment. It simplifies the task of the market surveillance, but also informs you consumer, safety advisors, purchasers, that. Example of a declaration of conformity generated through the cemarking assistant web application producing a declaration is one of the integral tasks involved in ce marking a product or machine.
There is a free guidance document on the content of technical files nbmed2. Being involved in both product development and technical communication, i have always been interested in ce marking. Technical documentation esrs for ce marking of pressure. Ce marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the european economic area eea.
Epa prepared this document to ensure that each indicator. Some products are subject to several eu requirements at the same time. This file can often make or break a devices certif. This technical support document tsd describes the process and methodology for the development of the advanced energy design guide for small hospitals and healthcare facilities shcaedg, which is intended to provide recommendations for achieving 30%. Pressure vessel rev no 1 job no 1234 issuing authority. These documents are in ipc1752 pdf format and are of the older rohs declaration statement, the statement may not detail exemptions. Technical documentation and eu declaration of conformity.
You mark them in your document, then create the index. To get more information about ce mark documentation kit click here email. The eu declaration of conformity which is the most common term used in ce marking is a document confirming that the product is placed in the. As a notified body, element can provide expert help and guidance to support products through the relevant testing process prior to ce marking a device. The technical documentation shall specify the applicable. Technical file for ce mark declaration template or. Mar 16, 2017 europe ce marking for medical devices under new mdr.
Most ce marking directives require that a full copy of the technical file is kept available for inspection in the territory of the european union. An index is simply a list of terms that you used in a document with the page numbers where those terms appear. The requirements of many of the ce marking directives and inparticular under the machinery directive 9837ec, you are required to create a technical file there are many ways to acheive this, however we can compile your technical files, enclosing all the relevant documentation. Access technical documents method sheets package inserts, material safety data sheets, and certificates are available without a customer login. True, many of these examples are as much as twenty years old. The eu declaration of conformity which is the most common term used in ce marking is a document confirming that the product is placed in the market in accordance with the relevant product legislation. Posts about ce marking documentation written by sarah francoise. The ctd was developed by the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich and adopted by the therapeutic goods administration tga in 2004. We encourage you to contact us for a free telephone consultation.
Design drawings and diagrams of components, subassemblies, etc. It also highlights the tools and technologies used in technical documentation as well as challenges in this field. If your company is located outside europe, you will have to find a person or company to retain the technical file. This video explains the purpose and content of introductions in technical writing. This makes the ce marking recognizable worldwide even to. Because part a needs to go to the authorized representative ar in europe, it is all hard. And, you should also include any other documents related to the ce marking process of your app that you may have. The technical documentation for a product plays a vital role in the ce marking process. Technical file for medical device mdr technical documentation so called technical file for medical device is a comprehensive file covering complete information to demonstrate safety and performance of the device against the manufactures claimed intended use. Proposal for a general product documentation 1 files 65. Technical documentation composition cemarking ce medical.
Overview this document provides technical supporting information for the 30 indicators and four chapterspecific callout features that appear in the u. Content and format for a technical file and design. Understand your technical documentation requirements posted on september 19, 2017 by sarah francoise testing a product according to the appropriate harmonized standards is just one step in the manufacturers ce marking certification processes. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. Ce marking ivd device step by step guide acorn regulatory. Production quality assurance via nb audit with issuance of ce marking certificate for ability to produce and test a device product verification via nb audit with issuance of ce marking. All european ce marking directives oblige the manufacturer to draw up a technical file or in the directives youll also find the term technical documentation.
The ce marking can only be applied to a product when it meets all of the essential requirements that have been set forth by the european new approach directives. Ce marking obtaining the certificate, eu requirements. Technical file for ce mark declaration template or sample of required contents. In addition to providing the necessary test reports, our esq services can support manufacturers through each stage of the ce marking process including any technical documentation obligations. Ce marking is a certification mark that indicates conformity with health, safety, and. Understand your technical documentation requirements. Product documentation technical file example medcert. The common technical document ctd is a set of specifications for a dossier for the registration of medicines. The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an eu declaration of conformity. In part a, the manufacturer must put all documents concerning the general design, manufacturing, and testing of the specific product. For a list of countries that require the ce marking, see. Usually, this version of the technical documentation is given to the surveillance authorities interested in verifying the ce mark.
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