The technical performance of ppe is specified by european norms, harmonized standards or in a technical file when harmonized standard does not exists. Medical appssoftware and what to include in the technical file. In part a, the manufacturer must put all documents concerning the general design, manufacturing, and testing of the specific product. New european medical device regulation mdr and in vitro diagnostic regulation ivdr the ce certificate will be issued by notified body.
Items to be described in declaration of conformity and technical documentation as explained above, in order to stick the ce marking on products, it is necessary to prepare and keep a declaration of conformity which declares that said products conform to applicable directives and include the related technical documentation. Product documentation technical file example medcert. Information to provide in your technical documentation submission. I realize that this may astonish you, but unlike other product certifications e.
The provisions regarding the ce mark compliances documentation are a part. Technical file for ce mark declaration template or sample of required contents. Ce marking selfcertification is maybe one of the best kept ce marking secrets by test laboratories and certification bodies. The aim of the technical file is to demonstrate the conformity of the product to the applicable requirements and eu medical device or ivd regulations. You should be able to find all useful aspects of performance, comfort and use limitations in the instructions for use. Apr 22, 2014 manufacturers should therefore pay close attention to the technical documentation requirements in order to have a better foundation upon which to meet the new european ivd regulatory requirements.
Ce marking can, in simple terms, be described as a passport or license to sell allowing free movement of goods within the internal market of the european. It is time to unveil this secret, so you can save a lot of time and money on your next ce marking project. Standards are now an important part of rohs 2 compliance since rohs 2 is now a ce mark directive. A technical file is a set of documents that describes a product and can prove that the product was designed and according to the requirements of a quality management system. 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. Very often you will find reference to this european norm as additional information on the product, the packaging or other.
Technical files what are they and what should they contain. Several ce marking directives require that the technical file is written in an official language of the member state where the procedures are to be carried out, or in which the approved certification body socalled notified body is established, or in a. Compiling your technical file or design dossier is a critical step in europes ce marking process and a requirement for compliance with the medical devices directive 9342eec, in. Technical file for ce mark declaration template or sample of. Medical device technical file and design dossier for eu ce. Celab can accomplish all the required tests in order to affix the ce marking related to emc, lvd, red, mdd, machines and many others.
Sample ce technical file documents for ce mark certification. Ce marking is a mandatory conformity mark enabling you to enjoy free movement between all 28 member states. 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. 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 provisions regarding the ce mark compliance s documentation are a part of the new approach directives. Dublin road, ballybrittas co laoise ireland contact. The technical documentation for a product plays a vital role in the ce marking process. Essentially, if an ivd carries a ce marking and will be sold in the eea, it needs a technical file. Industry in europe has brought to the attention of the european commission that they support the selfcertification of safe products with the cemark, and their opinion that third party notified body certification not become mandatory but be. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. In order to prove this, the ec requires the technical file, which is a compilation of records that describe the design and development history and maintenance plans of a finished medical device.
Technical file for ce mark declaration template or sample. At ce check, we will assist you in the creation of a technical file with all of. All products that have a ce mark must have a technical file which must contain the information that proves that the product conforms with the eu directives for ce marked. The ce marking an acronym for the french conformite europeenne certifies that a product has met eu health, safety, and environmental requirements, which ensure consumer safety. Ce mark technical file remediation service sterling. It is required to get your device into europe and several other parts of the world. The exact stepbystep system to correctly creating a ce marking technical file get your product approved to sell in the european market so you save time and money and grow your company. Determine, which directives and standards will be applicable for your product.
Learn the basics on technical files with our helpful guidance. The following technical file procedures refer only to procedures set forth in the directives that do not require intervention by notified bodies. I am looking for information on how to write a technical file for ce marking. Ce marking technical file for sensorex corporation product. 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. The technical file should have two versions, conventionally named part a and part b. 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. 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 ce marking technical file or design dossier class iii is a comprehensive description of your device intended to demonstrate compliance with european requirements. A technical file is much closer in nature to a 510k than a design history file. The technical performance of ppe is specified by european norms, harmonised standards or in a technical file when a harmonised standard does not exist. Normally the technical file does not have to be permanently available in material form, nor located within the territory of the community, provided it is capable of being assembled and made available in a reasonable period of time.
The technical file must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements. Does the ce mark tell me anything about the performance of the ppe. The manufacturer is responsible for affixing the ce marking, compiling a technical file which includes all the documents that prove that the product conforms to the technical requirements, and drafting an eu declaration of conformity stating that the product meets all legal requirements. Welcome to our publication of exporting to europe and ce marking. Depending on the product, ce marking may be as simple as formulating a technical file, or as complex as having. Manufacturers of medical devices are obliged to prepare and maintain documentation complying with the provisions in the medical device directive mdd.
Ce mark technical file asnzs emc construction file of product name tiger system models tiger3i380nx. A technical file is your documented evidence to show that a product properly complies with the requirements of the directives which apply to it. I have alot of info here but nothing seems to make sense as i have no idea what the compliance actions should be. Oct 08, 2012 only those product categories subject to specific directives that provide for the ce marking are required to be ce marked. When ce marking a medical app software, you must create and compile a technical file, where you need to include, as follows risk management documentation. European ce technical file or design dossier compilation. 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. Products to be sold in the european union eu that come under certain european directivesregulations must bear the ce mark it is a legal requirement. Technical file for ce declaration template or sample of required contents look at the thread, technical files please explain differences and what information would be included likes. Qnets machinery advisory technical file contents the first section of an advisory technical file written for our clients contains details of a hazard and risk assessment in which categories of risk are identified.
Accordingly, the manufacturer of record has the responsibility to develop a technical file, also called a technical construction file. Jan 23, 20 a technical file is your documented evidence to show that a product properly complies with the requirements of the directives which apply to it. Rivm rapport 265011003 assessment of technical documentation. Ce mark maintaining technical file and regulatory assessment. The key contents of the technical file is stipulated in each ce marking directive and a broad list of this is shown here. Understanding your technical documentation obligations. En55024cispr 24, en632 iec 632, and en633 iec 633 test report 4.
The individual directives have requirements on the ce mark. Comprehensive guide on class i isim medical devices ce marking mark. The ce marking logo free download ce mark logo the last step of the ce marking process is affixing the ce mark to the product. Best consultant for medical device technical file i3cglobal. Celab performs voluntary inspection activities on technical construction files to check their contents. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. What are the language requirements for the technical file. The technical file documents all steps a product has taken to comply with the ce requirements. Technical file for medical device is a must for all type of devices regardless of the risk classification. What is the meaning of a ce mark on personal protective equipment. For the machinery directive if the manufacturer is based outside the eueea a legal entity ie a company or person. Route map to ce marking determine that your product is a medical device classify your product according to risk category chose your conformity assessment route appoint a notified body if applicable construct a product technical file document iso 485 quality management system undergo regulatory audit and approval. Medical appssoftware and what to include in the technical. The file should not be confused with a technical construction file which is used by a manufacturer to show compliance via a nonharmonized route.
All ce marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product. Technical file what is it and how to create it ce check. Eu cemarking enforcement ce mark, ce marking medical. For example, the softwaredevelopment documentation part could contain information about. Technical file for machinery the technical file must demonstrate that the machinery complies with the requirements of this directive. Ce marking home the ce marking an acronym for the french conformite europeenne certifies that a product has met eu health, safety, and environmental requirements, which ensure consumer safety. Technical file for ce mark declaration template or. 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. The european directive 89686eec lays down the requirements for ce marking of personal protective equipment ppe. The directives require for many products that a technical file be compiled by the manufacturer. 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. Ce mark technical file remediation service sterling medical. A significant stage of the ce marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. Intertek will develop andor assemble existing documentation sections of technical information to create a technical documentation package based on requirements specified in the rohs2 directive and related standards.
Usually, each part of the technical file of your product can consist of more than one document. The ce mark signifies that a medical device is in compliance with european commission ec standards. The lvd strictly requires the manufacturer to have the file in place before the ce mark is applied, whereas the machinery directive says that the file does not have to be in constant existence and thereby provides for a period of grace in which it can be compiled. The provisions regarding the ce mark compliances documentation are a part of the new approach directives. The requirements for ce marking differ across all the directives and regulations and may also vary for different products within a directiveregulation. Manufacturers are legally required to affix a ce mark to their medical. And, you should also include any other documents related to the ce marking process of your app that you may have. Usually, this version of the technical documentation is given to the surveillance authorities interested in verifying the ce mark.
The technical file is your documentation of how you met the ce marking requirements for your product. Ce mark machinery technical file, 200642ec, ce marking machinery. Where the full quality assurance procedure referred to in article 123c and 124b has been applied, the ce marking must be followed by the identification number of the notified body. The directive references ce marking as per eu decision 7682008, annex ii, module a but that was not clear enough en50581 guidance document was released to clarify technical files requirements related to rohs directive 201165eu 6 rohs. 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. The exact stepbystep system to correctly creating a ce marking technical file get your product approved to sell in the european. How to write and compile a technical file for ce marking. Manufacturers are advised to start working on revising the ce marking regardless of notified body. Ce marking on a product indicates to all authorities that the product is in compliance with ce directives. The new approach directives require that the manufacturer compiles technical documentation technical file with information to demonstrate compliance with the applicable requirements. Technical files what are they and what should they. 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. Jun 24, 2019 i am looking for information on how to write a technical file for ce marking. The technical file is one of the corner stones of the ce marking process.
In general, the design, manufacture and operation of the product user. An investigation was carried out on the availability and quality of the technical documentation file of medical devices. This makes the ce marking recognizable worldwide even to people who are not familiar with the european. 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. A technical file is a set of documents that describes a product and can prove that the product was designed and according to the requirements of a quality management system all products that have a ce mark must have a technical file which must contain the information that proves that the product conforms with the eu directives for cemarked products. Guide on class i isim mdd medical devices ce marking. Jan 04, 2007 does anyone have a template or sample of the contents of a technical file to prepare for ce declaration.
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