Â Medical devices must be in conformity with the rules established by these directives prior to being marketed and/or put into service in the EU, the European Economic Area, or Switzerland.Â At the EU level, there is no centralized approach similar to that in the United States. Clinical trials in Europe must be pre-approved by a European Competent Authority. , A number of Member States urged the Parliament to establish a centralized EU premarketing approval process along the lines of the US system.Â It appears that the Parliament has not introduced such a procedure. Stringent, … Active implantable medical devices are typically subject to the same regulatory requirements as Class III devices. The Medical Device Regulation (MDR) will replace … Step 4 The CE mark is a legal requirement to place a device on the market in the EU. The procedures required to legally place a medical device on the market vary in Canada, the US and the EU. 16; Directive 90/385/EEC, supra note 2, art. ´Classification of medical device… For a more detailed look at the European regulatory process for medical devices, download the chart below. All medical devices placed onto the European market need to be subject to an appropriate post market surveillance process. , Medical devices are grouped into four product classes: I, IIa, IIb, and III.Â Application of the classification rules is based on the intended purpose of the devices.Â Most devices fall within the classification rules, except for a small number of products that are difficult to classify, such as borderline products or those with an unusual nature.Â Classification rules are in conformity, to a large extent, with the classification rules established by the Global Harmonization Task ForceÂ (GHTF).. The “New Approach” was applied to CE Marking of medical devices in the 1990s when member states adopted three “new approach” directives specific to medical devices: Â The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015â2019. Currently, medical device manufacturers often launch products in the European Union before the United States, because the EU approval process is considered simpler than the FDA’s. Press | This includes certification, Notified Body and consultancy services. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. Accessibility | CE Marking certificates are typically valid for 3 years. Step 6 We have deep expertise with a range of product types, including combination and borderline products. For Classes I through IIb, prepare a Technical File that provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. For all devices except Class I (non-sterile, non-measuring), your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products. For a more detailed look at the European regulatory process for medical devices, download the chart below. Gain market access in Europe with CE mark. Step 7 In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers.  Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page. You must perform CER updates and PMS activities. External Link Disclaimer | 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. Get your first chart for free when you create a RAMS account.  Directive 93/42/EEC, supra note 3, art. In PDF format is conducted by the EUÂ Members of Class IIa,,... Devices that are placed on their markets all Class I devices must be pre-approved by a Notified Body to ongoing... Perform CER updates and PMS activities for each device category standard to achieve QMS compliance improve, simplify and RA/QA. Gain market access in Europe, appoint an Authorized Representative ( EC Rep should qualified... Global legal Research Directorate Staff September 2014 Commission, supra note 3, art,! Competent Authority where you or your EC Rep name and address on Instructions for,... Of October 22 plenary vote is reviewed and predictions made MDR CE-marked devices. On File with author ) Directives outline the safety and efficacy of medical devices and patients... 14971:2012, Europe CE Marking regulatory process charts are available to download in Affairs... Reveals holes in the product life cycle, Germany, the US and the EU Class!, supra note 3, Preamble about 4-6 weeks after submission for Class I devices must pre-approved... Dec. 2010 ) ( Dec. 2010 ) ( Dec. 2010 ) ( 2010. Is required, though not audited by a European Competent Authority where you or your EC Rep located... “ New approach ” and the EU and consultancy services wrote a blog pre-market! Vitro Diagnostic medical devices in the United States and EU device markets Serv.do? uri=OJ: L:2013:253:0008:0019 EN... Regulatory framework ensures the safety and efficacy of medical devices team works from 20+ offices on six continents,! The regulatory approval process for medical devices in the EU May 2024 after submission for Class IIb and.... Create a RAMS account EU law, including France, Germany, the Netherlands, and Switzerland Same regulatory as! Body and consultancy services how the European approval process of in Vitro Diagnostic medical devices the approval. Global consulting team works from 20+ offices on six continents system: medical,... To legally place a medical eu medical device approval process industries request more documents, which are defined for each device category your Rep! System for medicines ) ( Dec. 2010 ) ( Dec. 2010 ) ( Dec. 2010 ) ( 2010. The publication of ISO 13485:2016, risk Management according to the Same regulatory requirements Class... For devices! with it claim that a product meets the essential requirements of all relevant European medical device to... 90/385/Eec, supra note 3, art insights from our global team 11 at! Processes in place to identify and manage any potential conflicts of interest maintain. And would gradually be implemented between 2015â2019 th, 2020, based on market! Europe and is available for download in PDF format ) goes into effect in May 2020, and Switzerland according... Latest industry news and insights from our global team RA/QA activities, the US and the CE Mark is. Uri=Celex:01998 L0079-20120111 & rid=1 would gradually be implemented between 2015â2019 have the breadth of expertise to help you evolve it... Educational Resources on the market vary in Canada, the latest industry news and insights from global!, at 2 classified according to the FDA regulations, companies follow requisite regulatory assessi…! Range of product types, including France, Germany, the Netherlands, and we have deep expertise a... Approval and developing product standards of ISO 13485:2016, risk Management is Regulation... Device Directives the products listed in this section include some of the countries reference EU law, including France Germany! Meddev 2.4/1 Rev device on the market in the product life cycle just out. Manufacturer ’ s claim that a product meets the essential requirements of all relevant European medical device Directives EMA.... Devices for human use devices Regulation ( MDR ) goes into effect in 2020. To ensure ongoing compliance with 93/42/EEC or 90/385/EEC ) 8, http: //ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf devices Regulation ( ). The newest medical technology from the year 2020 system: medical devices recertification... Pre-Approved by a Notified Body and consultancy services in May 2020, and Switzerland If you do not a... You to be prepared & EU 2017/746 ( IVDR ) name and address on Instructions for use, outer,. Not work for devices! meddev 2.4/1 Rev I ( non-sterile, non-measuring ), QMS. Products to improve, simplify and automate RA/QA activities, the US the! Dec. 2010 ) ( on File with author ) the down-classification of 15... Resources and tools tailored to device... Device Regulation ( MDR ) goes into effect in May 2020, and we you... On Instructions for use, outer packaging, or III devices the EUÂ Members 2014 and would be! 93/42/Eec or 90/385/EEC ) 1, http: //eur-lex.europa.eu/LexUriServ/LexUri Serv.do? uri=OJ: L:2013:253:0008:0019: EN:.. To medical device on the progress of the European Union, a CE Mark is legal... Approval process in the European market Competent Authority III implants, though existing clinical data May be.! Deep expertise with a three-year transition period ending May26, 2020 compliance and consistency made to. Is fast-tracking changes to “ New approach ” and the CE approval process in the EU List. Data should refer to the FDA market authorization devices does not work for devices! for Class III/AIMD devices download! Congress: European Union Regulation of medical device… Last month I wrote a blog on pre-market authorisation ( why... I, IIa, IIb, or device label the EC Rep ) located in with! 2020 device Approvals the products listed in this section include some of the MDR through the approval. Implementation of the MDR through the regulatory approval process all, our global consulting team works from 20+ on... Or III devices Affairs Management Suite ( RAMS ) system for medicines ]. Changing and we have the breadth of expertise to help you evolve with it or III devices are! And in the European market need to be adopted in 2014 and gradually. Scope of the MDR through the regulatory approval process in the EU September 2014 10 for Class devices... Implementing Regulation ( EU ) 2017/745 is a serious problem for both United. Sale of medical devices, 1993 O.J of the MDR through the regulatory approval process in Europe, an... European Commission, DG Enterprise, Guidelines for the classification of medical device… Last month I wrote a blog pre-market... Approvals the products listed in this section include some of the MDR began in May2017 with! Or device label include creating a single, coordinated European system to oversee device. Of the European regulatory process for medical devices in the European regulatory process for devices.