For medical auxiliary devices in specific, the european medical device directive mdd 9342eec l 169 was. Current directives current medical devices directivesranging from simple sticking plasters and contact lenses to sophisticated pacemakers and artificial hearts, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. Directive 200747ec of the european parliament and of the council. An introduction to international medical device standards. Fda compliance, eu medical device directive saline, mi. Directive mdd 9342eec and the eu medical device regulation mdr 2017745. Recognize unique device identification udi, the european database on medical devices eudamed, and information technology requirements. Understand in simple terms the in vitro diagnostic medical device directive 9879eec. B regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec. Challenges and opportunities in softwaredriven medical. Directive mdd 9342eec and the eu medical device regulation mdr 2017 745. If you are a manufacturer and you want to place your medical device on the eu market, you need to make sure it complies with the specific european directives set forth by the european commission.
The council of the european communities, council directive 9342eec official. Mdr classification rule 11 for medical device software. The regulation of software as medical device samd will be stricter under the mdr. Classification of software as a medical device bioslice blog. Medical device regulation ivd regulation ivdr medical device directive classification ce marking. Software lifecycle development is key for managing hazards. Switzerland is currently adjusting its laws to the development in the eu. The european commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Impact of eu medical device directive on medical device. The development of the iso 90003 standard as well as the european medical devices directive in 1993 helped bring some harmonization of existing laws with medical devices and their associated software. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices.
To keep up with advances in science and technology, 2 new european regulations are replacing 3 existing directives in the years up to 2022. Whereas council directive 90385eec of 20 june 1990 on the approximation of the laws of the member states relating to active implantable medical devices 7 is the first case of application of the new approach to the field of medical devices. Devices directive mdd andor the new european medical. If software is an accessory to a medical device, meddev 2. Official journal no page date m1 directive 9879ec of the european parliament and. For a manufacturer to legally place a product on the european market. The eu has a system of product directives that define the essential requirements for the particular types of products. If medical device software is produced for use on the european market it must be ce marked in accordance with the medical devices directive 9342eec as amended.
He has an extensive knowledge of medical device management systems and medical device regulations worldwide iso 485. An overview of the key impact points and challenges of european union medical device regulation. Software can be considered a medical device under eu law. Understand in simple terms the medical device directive 9342eec. Every medical device manufacturer who places a medical device in european market need to comply with european medical device regulations 2017745 mdr. Medical device software under the eu mdr emma international. Stricter rules for medical device software under the eu mdr. The qualification of software, either as a device or an accessory, is independent. General outlines of the european medicine device directive 2. The european union medical device regulation eu mdr is the most significant revision to the eu regulatory system in over 20 years. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. Classification of medical devices and their routes to ce.
Directive 200747ec of the european parliament amending medical device directive. Part one of our series on the european medical devices. Harmonised standards under the mdr regulatory affairs. Rule 11 will impede software development to an extend which makes it hardly possible for. The ce marking also means that the product can be freely marketed anywhere in the eu 27 member states of the eu and efta countries, iceland, norway and liechtenstein. Legally nonbinding guidance documents, adopted by the medical device coordination group mdcg in accordance with article 105 of regulation 7452017, pursue the objective of ensuring uniform application of the. Formally known as council directive 9342eec of june 14, 1993, concerning medical devices. Medical software development according to medical device. Biomedical engineering bme or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes e. Council directive 9342eec of 14 june 1993 concerning medical devices. Technical documentation remediation european medical. The eu commission is even considering revisiting this rule. 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. Yet according to a 2018 aberdeen survey, only 25% of life sciences.
European medical device directives the medical device directives is a new approach directive relating to the safety and performance of medical devices which were harmonized in the eu in the 1990s. The medical device regulation eu 2017745 mdr aims to harmonize the european market for medical devices, building on the directives. Final version of the european medical device and ivd regulations published on 5 may 2017. June 14, 1993 several amendments, most recent in 2007 where we are going. Have us and uk medical device regulators done all they can. For devices which incorporate software or which are medical software in themselves, the software must be validated according to state of the art taking into account the principles of development lifecycle. Intertek have seen false certificates on letterheads, or the use of intertek. Directive 200747ec of the european parliament amending medical device directive mdd provides medical device manufacturers with a compliance framework. 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. European council has released medical device regulation 2017745 on 25may2017 in place of medical device directive 9342eec and active implantable medical device directive 90385eec. To qualify a reader tool, the european medical device directives soon to be. In this case, the applicable directives are the medical device directive. 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.
Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. 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. Council of 5 april 2017 on medical devices, amending directive 200183ec. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections. On 15 july 2016, the european commission updated meddev 2. New european medical device regulation mdr 2017745. With about a year remaining until the new european medical device regulation takes effect to replace the current medical device directive 9342eec, its time to revisit what eu mdr means for medical. The medical devices directive aims to ensure the free. Regulations are rapidly evolving, but do they match technology. Classification of medical devices and their routes to ce marking. This paper is primarily focused on the medical devices regulation eu mdr and the requirements of the eu mdr apply in large to the medical device industry. With the upclassification of medical devices as per the new eu mdr, software used as a. Manufacturers in all 28 member states are bound to a piece of eu legislation called the medical device directive mdd.
Medical device regulation consulting team consulting. European medical device directive essential requirements checklist page 7 of 22. Annex ii qualification examples of medical device software mdsw according to. Eu medical devices directive mdd 9342eec and 200747ec. Brought about at least in part by the pip silicone implant scandal of the late 1990s and early 2000s, the overhaul of the european medical device regulations which resulted in the introduction of the mdr. European medical device regulation explained in simple.
Affairs cybersecurity corporate compliance programs product development. Countdown to the new eu medical device regulation mdr. European medical device directive essential requirements. In short, the new eu medical device regulation requires compliance with the international standard on usability engineering iec 623661. Stand alone software is considered to be an active medical device. In that case, of importance are the medical device directives mdd.
Because of the many types of devices covered by the mdd, the specific requirements depend on the classification and intended use of the device. Critech research has over twentyfive years of experience developing software and performing independent software verification and validation for regulated. Guidance internal market, industry, entrepreneurship and. According to the european framework, there are four classes of medical devices. Regulation 2017745 on medical devices and regulation 2017746 on invitro diagnostic devices were formally published in the official journal of the european union on 5 th may 2017. Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. The new europe eu medical device regulations mdr published by the european. According to article 1 of council directive 9342eec, medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the.
The european authorities and institutions still have to work elaborately on the harmonisation of standards under the medical device and invitrodiagnostics regulation. Computer software used in healthcare device applications. Meanwhile, in the eu, there is an ongoing effort to harmonise the most recent usability engineering standard, iec 623661. Only medical device companies that are in compliance with the new medical device regulation mdr 2017745 will stay in the european market after 26may2020. New eu mdr regulations and revamp of the medical device. Samd software as a medical device requirements for fda, eu. Official journal of the european communities, volume 36. Traditional cad software devices are manually coded by engineers to detect.
1057 712 740 364 495 799 624 1017 284 346 243 912 983 438 32 91 1045 1443 188 1230 1189 232 945 858 648 37 1485 1164 91