Because of the many types of devices covered by the mdd, the specific requirements depend on the. June 2011 in vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the european comission. The new eu medical device regulation eu mdr is not radically different from the current medical device directive mdd. European medical device directive essential requirements. Medical device directive mdd including amendments, the latest being directive 200747ec.
The amendments, along with changes to directive 988ec concerning the placing of biocidal. The medical devices directive aims to ensure the free movement of goods within the community, while providing patients, users and third parties with a high level of protection and attaining the levels of performance attributed to the medical devices. In laymans terms, the design dossier is the technical documentation plus a summary of the history of design changes for the device. Pdf the european medical device regulation 2017745eu. Dec 15, 2015 the european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease. Medical devices directive mdd, in vitro diagnostic device. Medical devices internal market, industry, entrepreneurship. Mdr medical devices regulation eu 2017745 regulation eu 2017745 also known as the medical devices regulation mdr has been adopted on may 25, 2017 and will replace the medical devices directive 9342eec mdd and active implantable medical devices directive 90385eec aimdd. This applies for medical devices requiring the ce mark in europe.
Because of the many types of devices covered by the mdd, the specific requirements depend on the classification and intended use of the device. Please enter a short name of your company so that we can allocate the documents you submitted. The directive, officially known as 9342eec, is one of the more frustrating mandates to decipher and understand, making compliance more difficult than it has. Guide on class i isim mdd medical devices ce marking. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on. Documentation preparation compile test and risk assessment reports, technical files and other documentation required for you to demonstrate product conformity. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices directive 200070ec of the european parliament and of the council of 16 november 2000 amending council directive 9342eec as regards medical devices incorporating stable derivates of human blood or human plasma. Medical device directive 9342eec since the 14th june of 1998 each medical device must carry a ce mark. The md directive is a new approach directive and consequently in order for a manufacturer to legally place a medical device on the european. Intertek semko ab, nb 04, have been made aware of a number of manufacturers selling medical surgicalface masks falsely claiming to be certified by intertek. Council councildirective93 eec42 14of june1993 concerningmedicaldevices. Further information on the revision of the medical device regulation can also be found on the eu website. Download mdr free mdr gap analysis mddmdr resources. European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 1 of 22.
Manufacturers may have an interest to anticipate compliance with the new legislation, for example in cases where they bring a new device type on the market for which the new. One of the more important impending requirements that manufacturers of medical devices must meet is the european union medical device directive. In vitro diagnostic medical device directive 9879ec the ivd directive was published in 1998 by the. Jan 27, 2015 you need to declare that your class iia device conforms to the requirements in the mdd as well as the medical devices regulations 2002. The directive requires notified bodies to take into account any pre mdd device and system approvals held by a manufacturer for his device or quality system prior to the directive coming into force. Determine if your product is a medical device and which eu directive applies to your device. Basic steps in the ce marking process are listed below. European medical devices regulation mdr 2017745 update. The new european medical devices regulation mdr eu 2017745 will legally apply from may 26, 2020, and sgs, like all other notified bodies, will no longer be authorized to deliver ce certificates under the medical devices directive mdd. If the appliance is at the same time a medical device within the meaning of directive 9342eec and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this directive. Medical devices directive mdd 9342eec explained in the medical device directive m. Technical documentation for medical devices guidance for submission. On 26 may, 2020, the medical device directive mdd will be replaced by the new medical device regulation mdr. European medical devices regulation mdr 2017745 update sgs.
We have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf, 7. In response to er 4 please provide information about. B council directive 9342eec of 14 june 1993 concerning. Directive 200070ec of the european parliament and of the council of 16 november 2000.
Directive 9342eec of the european union eu also known as the medical devices directive mdd details the essential requirements manufacturers and importers must meet to apply the ce mark and legally market or sell their devices in the eu. What is and is not a medical device 3 medical device directives that define what is a medical device c medical device directive c in vitro diagnostic medical device directive ivds c active implantable medical devices directive aimds. What is the abbreviation for medical devices directive. Medical device regulation 2017745 is set to replace the existing national requirements of the medical device directive mdd 9342eec within a specified time frame. Intertek have seen false certificates on letterheads, or the use of intertek s logo andor name and notified body number 04, as the basis for ce marking against the.
Medical devices directive 9342eec and ivd directive 9879ec will be repealed and will no longer apply in the eu. The medical devices directive mdd applies to all general medical devices not covered by the active implantable medical devices directive or the in vitro diagnostic medical devices directive. The number indicates the year of initial release 1993 and the consecutive number of directives in that year. Aug 29, 2017 we have created an interactive guide to the new eu regulations for medical devices mdr and in vitro diagnostic medical devices ivdr pdf, 7. European national states must translate this directive into national law. A medical device classification system is therefore needed, in order to apply to medical devices an appropriate conformity assessment procedure. In the transition phase a device could be ce marked under either the current directives, or the new regulations if they are fully compliant but this is dependent on the designation of notified bodies to the new regulations. European union 2 the eu is a unique economic and political partnership between 28 european countries that together cover much of the continent. Council of the european union, interinstitutional file. The longanticipated revisions to the medical device directive mdd 9342eec and the directive for active implantable devices 90385eec were published in the official journal of the european union on september 21, 2007. In order to ensure that conformity assessment under the medical device directive functions effectively, manufacturers should be. Compliance can be assumed by showing conformity to the appropriate standards listed by the european union as harmonised standards for the medical devices directive. Conformity to the international and european standard en iso 485 is voluntary. The mdr, which replaces the medical devices directive 9342eec and active implantable medical devices directive 90385eec, has a transition period of three years.
Requirement 4 of mdd 9342eec definitions of lifetime. Information and training presentation general provisions. Article 23 this directive is addressed to the member states. You also need to apply to a notified body to carry out a. Mdr medical devices regulation eu 2017745 mdi europa.
European medical device directive essential requirements checklist european medical device directive essential requirements checklist page 5 of 22 manufacturer. The european union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease falling under the medical device directive mdd. Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a global impact assessment in order to. Mdr is designed to be an improved version of mdd, with the major difference being that mdr influences and provides effectiveness to all eu member states. Directive 9879ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Medical device directive 2015 1 asean agreement on medical device directive the governments of brunei darussalam, the kingdom of cambodia, the republic of indonesia, the lao peoples democratic republic, malaysia, the republic of the union of myanmar, the republic of the philippines, the republic of. Medical devices directive 9342eec mdd and subsequent amendments. While most software is incorporated into the medical device itself, some is not. Medical device directive mdd including amendments, the latest being directive 200747ec, published as a consolidated text at. Products within the scope of mdd article 1 of the directive defines a medical device to mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used. In order to ensure that conformity assessment under the medical device directive functions effectively, manufacturers should be able to determine the. Directive 200070ec of the european parliament and of the. The medical device directive council directive 9342eec of 14 june 1993 concerning medical devices, oj no l 1691 of 19930712 is intended to harmonise the laws relating to medical devices within the european union.
In response to er 4 please provide information about the defined product lifetime not shelf life. Technical documentation and medical device regulation. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. Please find the latest consolidated ivdd 9879ec below. The european medical device regulati on 2017745 mdr 1 passed the european parliament. Bsi has published several white papers describing the mdr, the ivdr and how to start to prepare for them. Class i medical device without a measuring function and supplied in nonsterile condition does not require the involvement of a notified body. Medical devices directive 9342eec european commission. Before the new mdr regulation came into force, the md directive mdd meant that medical device manufacturers could come up with their own internal methods of compliance if they followed any of the meddevs andor en iso norms, which caused inconsistencies and safety issues amongst manufacturers. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. Fda definition of medical device a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is. The technical documentation must be kept in the premises of the manufacturer or the authorized representative in a clear, organized, readily searchable and unambiguous manner and shall include the elements presented in this document. Mdd abbreviation stands for medical devices directive.
Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. These service terms shall govern the medical devices directive and in vitro diagnostic devices directive notified body services to be performed by the ul contracting party as identified. They areconsidered the state of the art, and are considered not mandatory but in reality you will be unable to cemark a device without the use of. In order to obtain medical device approval in the eu, medical devices must be correctly classified. On 26 may 2017, a new regulation entered into force, meaning that by 26 may 2020, for manufacturers to obtain. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles. Medical device directive mdd 9342eec as amended by 200742ec pavan kumar malwade 01 april 2016 1 2. Medical devices guidance document classification of medical. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. The mdr is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which. The manufacturer determines through the label, the instruction for use and the promotional material related to a given device its specific medical purpose. Medical device directive 9342ewg mdd the mdd is the medical device directive or 9342eec.
As a result, sgs will guide its customers through the process of transferring their certificates from mdd. Medical device directive 9342eec cemarking qnet, llc. Technical file document iso 485 quality management system undergo regulatory audit and approval. For all classes a technical file must be prepared, demonstrating compliance of the device with the directive s essential requirements. Thats not to underestimate the amount of work that will be required to switch from the current mdd to the new eu mdr. The ivd directive was amended and corrected over time.
Certainly, for the manufacturer who produces medical devices for the eu market today, and who wants to. Council directive 9342eec of 14 june 1993 concerning medical devices. Directive whereas certainmedicaldevices are intended to administermedicinal products withinthemeaning of. Mdd annex x clinical evaluation medical devices directive explained how medical devices are regulated in europe medical device validation. When considering the medical device, the criteria for risk acceptability is. Medicines can be marketed for use in combination with a medical device, usually to enable the delivery of the medicine if the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under directive 200183ec or regulation ec no 7262004. Preparing a european technicalfile for a medical device. Essential requirements medical devices directive applicable yn applied standards, procedures, justification evaluati. For classification purposes an accessory may be classified as though it is a medical device in its own right. Medical devices guidance document classification of. If the ancillary substance is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines, the notified body must seek a.