Countdown to the new eu medical device regulation mdr. The eu commission is even considering revisiting this rule. Harmonised standards under the mdr regulatory affairs. New eu mdr regulations and revamp of the medical device. He has an extensive knowledge of medical device management systems and medical device regulations worldwide iso 485. Final version of the european medical device and ivd regulations published on 5 may 2017. General outlines of the european medicine device directive 2. The qualification of software, either as a device or an accessory, is independent.
Mdr classification rule 11 for medical device software. 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. European medical device directive essential requirements. Samd software as a medical device requirements for fda, eu. The council of the european communities, council directive 9342eec official. Software can be considered a medical device under eu law.
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. The european union medical device regulation eu mdr is the most significant revision to the eu regulatory system in over 20 years. The european authorities and institutions still have to work elaborately on the harmonisation of standards under the medical device and invitrodiagnostics regulation. 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 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. Directive 200747ec of the european parliament and of the council. Biomedical engineering bme or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes e.
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. Challenges and opportunities in softwaredriven medical. 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. 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. Affairs cybersecurity corporate compliance programs product development. 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. 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. 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.
An overview of the key impact points and challenges of european union medical device regulation. Regulations are rapidly evolving, but do they match technology. In this case, the applicable directives are the medical device directive. In that case, of importance are the medical device directives mdd. Directive 200747ec of the european parliament amending medical device directive mdd provides medical device manufacturers with a compliance framework. The regulation of software as medical device samd will be stricter under the mdr. Only medical device companies that are in compliance with the new medical device regulation mdr 2017745 will stay in the european market after 26may2020. With the upclassification of medical devices as per the new eu mdr, software used as a. Computer software used in healthcare device applications. Medical device software under the eu mdr emma international. Technical documentation remediation european medical. On 15 july 2016, the european commission updated meddev 2.
Part one of our series on the european medical devices. For medical auxiliary devices in specific, the european medical device directive mdd 9342eec l 169 was. European council has released medical device regulation 2017745 on 25may2017 in place of medical device directive 9342eec and active implantable medical device directive 90385eec. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices that monitor diabetes or identify infections.
Meanwhile, in the eu, there is an ongoing effort to harmonise the most recent usability engineering standard, iec 623661. To keep up with advances in science and technology, 2 new european regulations are replacing 3 existing directives in the years up to 2022. 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. New european medical device regulation mdr 2017745. Medical software development according to medical device. Guidance internal market, industry, entrepreneurship and. 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. An introduction to international medical device standards. Impact of eu medical device directive on medical device software. For a manufacturer to legally place a product on the european market.
The medical device regulation eu 2017745 mdr aims to harmonize the european market for medical devices, building on the directives. Traditional cad software devices are manually coded by engineers to detect. Because of the many types of devices covered by the mdd, the specific requirements depend on the classification and intended use of the device. European medical device regulation explained in simple. 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. Classification of medical devices and their routes to ce.
Council directive 9342eec of 14 june 1993 concerning medical devices oj l 169 of 12 july 1993. The european commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Directive 200747ec of the european parliament amending medical device directive. Have us and uk medical device regulators done all they can. Understand in simple terms the medical device directive 9342eec. Council directive 9342eec of 14 june 1993 concerning medical devices. Intertek have seen false certificates on letterheads, or the use of intertek.
European medical device directive essential requirements checklist page 7 of 22. 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. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens. Manufacturers in all 28 member states are bound to a piece of eu legislation called the medical device directive mdd. If software is an accessory to a medical device, meddev 2. Devices directive mdd andor the new european medical. Every medical device manufacturer who places a medical device in european market need to comply with european medical device regulations 2017745 mdr. Council of 5 april 2017 on medical devices, amending directive 200183ec. Classification of medical devices and their routes to ce marking.
Annex ii qualification examples of medical device software mdsw according to. Official journal of the european communities, volume 36. 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. 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. June 14, 1993 several amendments, most recent in 2007 where we are going. Understand in simple terms the in vitro diagnostic medical device directive 9879eec. Medical device regulation ivd regulation ivdr medical device directive classification ce marking. 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.
Directive mdd 9342eec and the eu medical device regulation mdr 2017 745. Classification of software as a medical device bioslice blog. Deploy postmarket surveillance, report serious incidents, and. Yet according to a 2018 aberdeen survey, only 25% of life sciences. In short, the new eu medical device regulation requires compliance with the international standard on usability engineering iec 623661. Medical device regulation consulting team consulting. Fda compliance, eu medical device directive saline, mi. The medical devices directive aims to ensure the free. To qualify a reader tool, the european medical device directives soon to be. Directive mdd 9342eec and the eu medical device regulation mdr 2017745. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. 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. Official journal no page date m1 directive 9879ec of the european parliament and. Stand alone software is considered to be an active medical device.
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. Rule 11 will impede software development to an extend which makes it hardly possible for. According to the european framework, there are four classes of medical devices. 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. The new europe eu medical device regulations mdr published by the european. From sticking plasters to xray scanners, dentures to hip joints and invitro diagnostic devices. Recognize unique device identification udi, the european database on medical devices eudamed, and information technology requirements.
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