Ultimate guide to medical device design and development pannam. Therefore, drafting an ifu contributes to risk reduction of the medical device. Japan is the second largest medical device market in the world, with medical devices imported from outside of japan representing a substantial percentage of total market share. Plm best practices for medical device manufacturers to. How to comply with eu regulations in addition to being environmentally friendly, electronic distribution of operating manuals or instructions for use ifus offers key advantages over the paper versions for both manufacturers and users. Blood glucose meter, pocket size this common medical device is used by many different types of users. Acceptable media for electronic product user manuals march. Oct 23, 2017 a comprehensive guide for medtech professionals to design and develop effective medical devices. If your device lacks usability, market share will suffer, but if your device doesnt meet regulatory guidelines, it wont make it to the ultimate guide to medical device.
Eu country specific medical device registration requirements. Medical devices are becoming more important in the health care sector. Generally, medical device patient labeling is used by the intended user of the. Making sense of your medical device ifu healthcare. Tips for developing medical device user needs intended uses. Medical device design and development is a complex process rife with regulations, specifications, application requirements, and end user needs all of which must be balanced and adhered to for a successful product. However, it is also functional as a manufacturer ensures to inform the user of the medical device on the intended use and any residual risks. The director of the center for devices and radiological health may require a manufacturer of a radiation. Ifu medical devices template writing a user manual. This thesis examines the regulatory requirements for medical devices in argentina. Consistent worldwide requirements for medical device labelling would offer significant benefits to. This requirement is contained in article 6 2 of the medical.
The term intended use includes medical devices, strictly speaking in two aspects. Manufacturers tend to believe that the user stories are a suitable to identify the real user requirements. Medtronic medical equipment user manuals download manualslib. Taking total product life cycle into consideration from the very start is key to success. Requirement for a printed copy of the user manual with a. Typically an ifu includes basic operational how to information as well as pages of warnings, cautions, and other general or devicespecific information beyond simply how to operate the device.
How to identify medical device customers and their needs. Because of the diversity of medical devices, a guidance document for patient labeling must consider all the different types of patient labeling that exist. You can use the template to create instructions that comply with the ce marking requirements, the medical device regulation eu 2017745, the en 8201791 standard for user instructions. For example, in the netherlands, labels and instructions for use must be in dutch. Filing data a filing form for class i medical devices b safety risk analysis report. Food and drug administration fda design controls, they often place a lot of emphasis on design inputs and outputs, verification, transfer, and the design history file. For example, there are directives for machines and medical devices, but also for pressure vessels and toys. The primary purpose of labelling is to identify the medical device and its. The authorised use, including the intended use, but also other planned actions of the user with this medical device such as storage, transport, update or cleaning. Plm best practices for medical device manufacturers to ensure quality 2 ebook using arena plm arena offers a simple and affordable product that allows medical device companies to manage their development process including dmr, dhf, docs, procedures in fda and ce standards. The user manual is an important part of the ce marking requirements. The personal protective equipment ppe directive annex i, paragraph 1.
User manuals, medtronic medical equipment operating guides and service manuals. For machinery and installations user manual requirements are mentioned in the machinery directive 200642ec under annex i, paragraph 1. The manual and the device booklet, which proves that you are the legitimate owner. Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. Design validation is one of the most important aspects of the design and development process for medical devices. User requirements for the mobile application savvy heart sensor ecgalert is intended to be used with an ecg sensor that has already been certified with a ce mark 4, such as savvy. Consider the challenges facing technical communicators i. Clinical engineering bank manuals clinical engineering bank is the site where you can find most of the information required for the clinical engineering department and professionals in healthcare institutions.
However, some medical devices may be affected by other legislation which must also be complied with before the devices may be legally supplied. You can use the template to create ifu that complies with the ce marking requirements, the medical device regulation medical device directive, the en 82079 standard for user instructions and the ansi z535. You can use the template to create instructions that comply with the ce marking requirements, the medical device regulation eu 2017745, the en 8201791 standard for user. Commission regulation eu no 2072012 of 9 march 2012. Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. The ifu medical devices template is an ms word template, that contains all mandatory elements to create your own information for use for medical devices. Commission regulation eu 2072012 on eifus for medical devices is applicable in all eu member states without the need for any member state transpositions. Information to verify whether the device is properly installed. Feb 01, 2012 hi everyone, does any one know if it is mandatory to include a printed version of the users manual with a medical device.
You can use the template to create instructions that comply with the ce marking requirements, the medical device regulation. It is the responsibility of an economic operator usually the manufacturer to. Wound treatment system users manual infiniti medical. The medicines act 1981 and its regulations describe the regulatory scheme for the supply of medical devices in new zealand. Only devices annotated by are also exempt from gmp except for general recordkeeping requirements and compliant files. The user can determine this quantity according to a products characteristics and frequency of use in your hospital. Also, is there a difference between eu and us regulation on this mater. First, their work must address the needs of an especially diverse audience, starting with caregivers and extending to trainers, biomedical engineers, sales personnel, government regulators, and many others. Ghtf sg1 label and instructions for use for medical. Specifications the user requires to use the medical device appropriately, e. One of the most important steps in medical device development is defining the requirements of your medical product early on to prevent costly revisions later and delayed time to market. Understanding the regulatory requirements of the japanese medical device market.
One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the 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. Free to download eu medical device classification form. Fda has developed this guidance document to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This curato wound treatment system users manual is not a guarantee or warranty. Iso 15223 medical devices symbols to be used with medical device labels, labeling, and information to be supplied part 1. The drafting of an ifu for medical devices is, for the most cases, obligatory. The code of federal regulations cfr title 21 part 1002. The definitive guide to ifu for medical devices instrktiv. The actual medical purpose, that is, which disease or injury you can diagnose, treat or monitor. Global translation requirements for medical devices emergo. Recommendations for developing user instruction manuals for. The cfda, the china food and drug administration, was replaced on september 1, 2018 by the national medical products administration nmpa, which reports to the chinese ministry of health this article will provide you with further information on the work and responsibilities of the cfdanmpa and the approval of medical devices in china.
Ghtf sg1 label and instructions for use for medical devices. Andrew wu, software consultant at rook quality systems. Requirements for validated reprocessing instructions and reprocessing validation data for reusable medical devices a reusable medical device is one intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing steps between uses. Prepare the report according to the relevant requirements specified in yy 0316 application of risk management to medical device, and the content of the report mainlys include judgment of the. A guide to developing usable instructions for use for medical devices by arathi sethumadhavan, naomi cherne, and adam shames, core human factors inc medical devices can be complex and may require users to understand specific information about. Working at the intersection of project and quality management, i believe better practice in software development and computer system validation can greatly benefit companies who are trying to put their novel medical technology in the hands of providers or patients. The elabelling regulation is only applicable to medical devices, not for ivds. The savvy sensor is covered with waterproof and biocompatible plastic housing. In this article, well answer your biggest questions about requirements and best practices for translating device labeling and instructions for use ifu. Increasingly companies are rethinking the way they approach user manuals. In a recent usa today poll that asked readers which technological things have the ability to confuse you. For professional use only, mdd and ivd software is accepted in english or german according to the wish of the user. These people want to learn to use medical devices so the patient. Software user interface requirements for medical devices.
User interface can be in english, provided that the information required for the safe use of the product is included in czech language into user manual or into another document available for the user. As with any prescription medical device, failure to follow product instructions or changing. Requirements and instructions for filing data of class i. The guide will walk you through fundamentals of medical device design and development, provide information on processes, and. Medical device makers can ensure that products are built with user needs at the forefront by setting up stringent approaches to design and creating extensive documentation to direct those processes.
Following is a breakdown of 510k exempt and good manufacturing practice gmpquality system exemptions listed by device class. The medical device industrys movement toward computerization of user manuals parallels similar movements in the medical industry as a whole. Nov 03, 2016 below are two examples that illustrate how the user and their needs may change based on the device use. Nov 24, 2010 you have to prove, within the technical file, that your product meets the essential requirements of the medical device directive 9342eec, amended by 200747ec which is applicable since march 2010. Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. In addition, electrical medical devices have labeling requirements defined in iec 606011. Emergo has a wellestablished presence in the eu with offices in the uk, germany, france, and the netherlands. They can be an operators manual, a separate instruction leaflet or a user guide.
Medical device user fee cover sheet form fda 3601 the first page of a 510k should be a printed copy of the medical device user fee cover sheet form fda 3601. Download 8 medtronic medical equipment pdf manuals. If the device is an implant listed in schedule 2 of the regulations, the manufacturer is required to include two implant registration cards, as detailed in sections 66 and 67. Software user interface requirements for medical devices by david a. The engineers or vendor can then commence the preliminary design to establish exactly what functions are required for each of the items specified in the user requirements specification, the end user has listed.
Bioclinical service bcs is a site provide medical device user manuals for hospitals. Hi everyone, does any one know if it is mandatory to include a printed version of the users manual with a medical device. However, medical device companies may apply to the competent authorities for derogations or exemptions. Nov 14, 20 one of the most important steps in medical device development is defining the requirements of your medical product early on to prevent costly revisions later and delayed time to market. These documents should present the user needs and intended uses for a device, outlining verifiable design input requirements and providing a.
Fda passes on setting new regulations for medical device. You must meet the requirements in the relevant regulation before your device can be placed on the market. The eu 2017745 regulation replaces the medical devices directive 9342eec and the active implantable medical devices directive 90385eec. Emergo analysis of european mdr and ivdr publication. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in canada. User instructions for medical devices used in home health care. The ifu medical devices template is an ms word template, that contains all. Emergo can help you obtain eu ce marking for your medical device. It is now time to devote oneself, if not to the study, at least to the reading of the general essential requirements for safety and performance included in annex i of the regulation on medical devices, mdr 2017745, and in vitro diagnostic medical devices, ivdr 2017746.
Labeling regulatory requirements for medical devices fda. Typically an ifu includes basic operational how to information as well as pages of warnings, cautions, and other general or device specific information beyond simply how to operate the device. White paper developing product requirements for medical. Paper is disappearing all over the hospital with the advent of information networks and the related software applications. Identifying medical device user needs medical product design. Mandatory languages requirements for medical devices. Mandatory languages requirements for medical devices update sept. Some medical devices do not include patient labeling, while other devices include comprehensive manuals. A guide to developing usable instructions for use for medical. May 06, 2014 essentially all medical devices used in hospitals come with a user instruction manual, commonly called instructions for use ifu or directions for use. Instructions for use for mdd and ivd products as well as reagent and. You can use an alternative approach if the approach satisfies the requirements of.
Medical device problem reporting and the health care professional pamphlet. Specific labelling requirements for these types of licence applications are described in the guidance document entitled, instructions for completing the. Jun 28, 2017 the requirements for medical device files in iso 485. Design validation and regulatory requirements medical. The new medical device regulation will enter into force from may 26th 2020. It is at this stage that the medical device manufacturer confirms that the device that was designed is the right product that meets the needs of the user. User interface can be in english, provided that the information. The food and drug administration fda or agency has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications 510ks instructions for use which have been validated and validation data regarding cleaning, disinfection, and. Essentially all medical devices used in hospitals come with a user instruction manual, commonly called instructions for use ifu or directions for use.
Document change log change location section, paragraph nature of andor reason for change. Fortunately, guidance documents can help device manufacturers. We have assisted hundreds of medical device manufacturers with ce compliance for europe. Publishing user information on a manufacturers website makes regulation eu 2072012 on elabelling applicable.
May 17, 2018 fda passes on setting new regulations for medical device servicing. Ifu arrive at medical and dental facilities in several forms. Device advice introduction to labeling requirements for medical devices. Food and drug administration fda design controls, they often place a lot of emphasis on design inputs and outputs. Successful design validation requires a thorough understanding of the user needs. User manual template medical certification experts. Once this functionality is documented and approved it forms the urs level2 document. All devices in this list are 510k exempt unless further qualified by a footnote. Ce requirements for user manual certification company. Apr 20, 2015 number of productlevel requirements documents for a device at a medical device product level, there are two common practices for constructing requirements. Medical device exemptions 510k and gmp requirements. Section 206 of the medical device user fee and modernization act. Mdmv6b vimove wireless medical device user manual dorsavi pty.
The ifu medical devices template is an ms word template, that contains all mandatory elements to create your own ifu for medical device. Rewritten to add clarity, conform to good guidance practices and proposed regulatory amendments as per the regulations amending the medical devices regulations decorative contact lenses and mandatory class ii medical device label submission. For some complex, active or powered devices, the directions for use may require a special surgeons instruction manual, operators manual, and a users manual. Iec 62304 medical device software life cycle processes iec 62366 medical devices application of usability engineering to medical devices. The regulation defines eifus as instructions available from a web site, supplied in portable electronic media e. The meter and strips are typically supplied to the user in a box from a pharmacy or diabetic supply company. User requirements can be validated with a product, not user needs. Mdr and ivdr essential requirements for instructions for. It is the responsibility of an economic operator usually the manufacturer to verify if ce marking directives relevant to its product contain mandatory requirements for a user manual. A guide to developing usable instructions for use for. Matrix requirements offers solutions for medical devices companies. In this article, ferry vermeulen what is required regarding the user manual, as well as other ce requirements. Music 3s user manual details for fcc id 2akztdmvme03s made by smart medical device co.
The european mdr and ivdr require medical device manufacturers to publish user information on their websites. The first is to use a single requirements document that captures user needs and intended uses, as well as verifiable design input requirements. Jul 30, 2019 its a fillable pdf where you can provide all the information of your medical device and select which classification is applicable. Although the system is well established, its practical application is not completely clearcut. Jan 01, 2002 in fact, medical device salespeople frequently encounter customersthe chair of a hospitals device selection committee, for examplewho insist on judging a product based on how easy it is to use without any training, assistance, or referrals to the user manual. For reusable devices, information on the processes for cleaning, disinfection, packaging and, if applicable, the validated method of resterilisation as determined by the country where the product is sold and used. Instructions for use and medical devices ce mark medical.