The regulations were published in the Official Journal of the European Union on May 5th, 2017 and entered … [17] Commission Implementing Regulation (EU) No. 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. [5]  The European Medicines Agency of the EU, unlike the Federal Drug Administration in the United States, is not involved in the approval process of medical devices. Download our MDR process chart. Legal | Clinical studies are required for Class IIb and III implants, though existing clinical data may be acceptable. The EC Rep should be qualified to handle regulatory issues. For all devices except Class I (non-sterile, non-measuring), you will be issued a European CE Marking Certificate for your device and an ISO 13485 certificate for your facility following successful completion of your Notified Body audit. Failure to pass the audit will invalidate your CE Marking certificate. [13]  The affixing of a CE marking on medical devices, which is the last stage in the approval process, indicates that those medical devices conform with the requirements provided for in the legislation.  The legal value of the CE marking lies in its proof that the medical device concerned is in full compliance with applicable legislation.  On the other hand, the CE marking does not represent quality, even though consumers often assume that products bearing the CE marking are of better quality than others. [11]  Clinical data are also required to ensure conformity with the requirements of the Medical Devices Directive[12] for class III devices and implantable medical devices. Manufacturers, prior to placing their devices in the market, are required to determine the classification of a device, based on the risk factors associated with each device, and then to apply the appropriate conformity route. The first step in the approval process is taken by the manufacturer, who is required to determine the class of its medical device in order to apply the appropriate conformity assessment rule.  Medical devices are classified on a “risk-based” system. Learn from our experts through live events. Comprehensive service offerings at every point in the product life cycle. For Classes I through IIb, prepare a Technical File that provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. This long, exhaustive regulatory framework is used by medical device companies to attain the FDA market authorization. [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. The European Medicines Agency of the EU, unlike the Federal Drug Administration in the United States, is not involved in the approval process of medical devices. [18] Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, COM (2012) 542 final, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf; Proposal for a Regulation for In Vitro Diagnostic Medical Devices, COM (2012) 541 final, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf. The aim of the MDR is to ensure compliance and consistency. and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. 2020 Device Approvals The products listed in this section include some of the newest medical technology from the year 2020. The new EU Medical Device Regulation (MDR) will impact not just CE-marked medical devices in the European Union but also drug/device combination products. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? [9], Medical devices are grouped into four product classes: I, IIa, IIb, and III.  Application of the classification rules is based on the intended purpose of the devices.  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.  Classification rules are in conformity, to a large extent, with the classification rules established by the Global Harmonization Task Force (GHTF).[10]. [21], Global Legal Research Directorate Staff Determine classification of your device using Annex IX of the Medical Devices Directive (MDD): Class I (non-sterile, non-measuring), Class I (sterile, measuring), Class IIa, Class IIb or Class III/AIMD. CLASSIFICATION SYSTEM: Medical devices are classified according to risk, based on EU classes. [17], In 2012, the European Commission, due to diverging interpretations and applications of the legal regime on medical devices by the Members, new technological developments, and the public concerns raised by the scandal of a French manufacturer using industrial silicone for breast implants in France, moved to reform the legislation on medical devices. The US regulatory controlsare documented in accordance with the Federal Food, Drug, and Cosmetic Act and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. The European Database for Medical Devices (EUDAMED) is a database that will be used to monitor the safety and performance of medical devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). CE Marking certificates are typically valid for 3 years. (L 247) 21, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf. ´Classification of medical device… View All. Device Application Process Because there is so much variation in the classification of devices, developers have a variety of options. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1. Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. About | The Medical Device Regulation (MDR) will replace … 11. art. The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. IVD Devices: Same as in the EU – List A & B, Self testing, all others. [14] European Commission, supra note 11, at 2. [12] Directive 93/42/EEC, supra note 3, Annex I.Â. This includes certification, Notified Body and consultancy services. [8]  The classification rules of medical devices, as established in Annex IX of Directive 93/42/EEC on Medical Devices, depend on the vulnerability of the human body, taking into account possible dangers inherent in the technical design and manufacture of the devices. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. Get your first chart for free when you create a RAMS account. All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). This report describes the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available. Step 10 What is the Medical Device Regulation (MDR)? Most of these data should refer to the subject device. EU Members are in charge of implementing the legislation and taking any measures required to ensure that medical devices meet the required criteria prior to being marketed in the EU and/or put into service. [4] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices, 1998 O.J. 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. External Link Disclaimer | UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF. Determine which EU Medical Device Directive applies to your device: 93/42/EEC – Medical Devices Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices Directive (AIMDD): Step 2 This is a simplified overview of the process. Step 3 ´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices . Active implantable medical devices are typically subject to the same regulatory requirements as Class III devices. ISO 13485 certification must be renewed every year. Step 5 Accessibility | EU countries. The CE mark is a legal requirement to place a device on the market in the EU. Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) EU Parliament is fast-tracking changes to “New Approach” and the CE Mark approval process. If you do not have a location in Europe, appoint an Authorized Representative (EC Rep) located in Europe. Determine classification of your device … All devices require will require clinical data. 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