Determine classification of your device … 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. What is the Medical Device Regulation (MDR)? The EC Rep should be qualified to handle regulatory issues. This is a simplified overview of the process. View All. [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. Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. [12] Directive 93/42/EEC, supra note 3, Annex I.Â. 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. [15] Directive 93/42/EEC, supra note 3, Preamble. Also, monitor any other changes that may impact on the regulations. ´Classification of medical device… For a more detailed look at the European regulatory process for medical devices, download the chart below. View All. Step 4 [17] Commission Implementing Regulation (EU) No. [21] European Commission, Memo, Questions and Answers: Commission Tables Proposals for a New EU Regulatory Framework for Medical Devices and In Vitro Diagnostic Medical Devices (Sept. 26, 2012), http://ec.europa.eu/ health/medical-devices/files/revision_docs/qa_20120926_en.pdf. [14]  For class I devices, the conformity assessment procedure can be carried out by the manufacturer alone, due to the low level of risk associated with such products.  For class IIa devices, the intervention of a notified body is mandatory at the production stage.  For devices falling under classes IIb, such as implants and contraception products, and III, which pose a high risk, the notified body is tasked with being involved in the design and manufacture of the devices. View All. We have deep expertise with a range of product types, including combination and borderline products. 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. ´MDD 93/42/EEC Medical Device Directive. The products in each list contain information about … Most of these data should refer to the subject device. Device Application Process Because there is so much variation in the classification of devices, developers have a variety of options. Meet our MDR team and get free educational resources on the MDR. [6] Directive 93/42/EEC, supra note 3, art. USA.gov, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01993L0042-20071011&rid=1, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 L0079-20120111&rid=1, http://www.eucomed.org/uploads/ModuleXtender/Newsroom/97/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf, http://ec.europa.eu/health/medical-devices/files/revision_docs/pr_20120926_en.pdf, http://www.reuters.com/article/2013/10/22/us-eu-medtech-idUSBRE99L0TH20131022, http://ec.europa.eu/ health/medical-devices/files/revision_docs/qa_20120926_en.pdf. 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. The system will launch on March 25 th, 2020. Jobs | The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.. [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. Place EC REP name and address on Instructions for Use, outer packaging, or device label. [18]  In brief, the pending legislation establishes new rules on the traceability of medical devices back to the suppliers; stronger supervision of independent conformity assessment bodies (notified bodies) by national authorities; and additional powers for notified bodies vis-à-vis the manufacturers, including unannounced inspections in factories. Approval Process for Medical Devices. Gain market access in Europe with CE mark. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. EU countries. In general, all devices must meet the essential requirements irrespective of the class of the devise, be subject to the reporting requirements under the national supervisory system, and be CE marked, except custom-made devices and those intended for clinical investigation. Get your first chart for free when you create a RAMS account. By working ... A consistent approach to medicines regulation across the European Union EMA medicines. 920/2013 of 24 September 2013 on the Designation and the Supervision of Notified Bodies Under Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices, 2013 O.J. The EU first passed the Medical Device Regulation (EU MDR) in 2017 to replace the previous EU Medical Device Directive (MDD). Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. View All, Our global consulting team works from 20+ offices on six continents. Step 10 For Class I (non-sterile, non-measuring), a QMS is not formally required. Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. Accessibility | 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. Step 7 The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. According to the FDA regulations, companies follow requisite regulatory steps assessi… [7]  Medical devices and in vitro medical devices produced in third countries (outside the EU) must conform with the EU legislation. In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. September 2014. Comprehensive service offerings at every point in the product life cycle. (L 169) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01993L0042-20071011&rid=1, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, art. [16] Id. If you do not have a location in Europe, appoint an Authorized Representative (EC Rep) located in Europe. In the United States, only about 2% of medical devices approved in the last 10 to 12 years have undergone Premarket Applications, the most rigorous process for FDA device approval . 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. TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1. View All. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? [15], Notified bodies play a vital role in the approval process since they are tasked to ascertain that medical devices marketed in the EU meet all requirements pursuant to the class assigned.  Notified bodies are conformity assessment bodies, staffed by experts and designated as such by Member States.  The Member States must report the names of the notified bodies to the Commission, which publishes a list of the bodies, along with the tasks assigned to them. ´CE Marking approval process. Clinical trials in Europe must be pre-approved by a European Competent Authority. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product. All Class I devices must be registered with the Competent Authority where you or your EC REP is based. IVD Devices: Same as in the EU – List A & B, Self testing, all others. [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). Impact of October 22 plenary vote is reviewed and predictions made. Active implantable medical devices are typically subject to the same regulatory requirements as Class III devices. Stringent, … Different regulatory bodies are involved, requiring different types of submissions (Table 1) and review timelines depending on the classification of the device. [19] Press Release, European Commission, Safer, More Effective and Innovative Medical Devices (Sept. 26, 2012), http://ec.europa.eu/health/medical-devices/files/revision_docs/pr_20120926_en.pdf.  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.  Medical devices are assessed for efficacy and safety by notified bodies, which are private organizations staffed by experts and certified by the EU Member States.  In the final stage, medical devices, with some exceptions for such things as custom made devices and devices intended for clinical investigation, are given a CE marking, which ensures that medical devices are in conformity with EU rules and are ready to be marketed.[6]. Some EU member states require additional registration of Class IIa, IIb, or III devices that are placed on their markets. While the CE mark takes less time to obtain and devices may be available earlier than in the U.S., the FDA’s strict procedures may be seen as safer for consumers. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. 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. ´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices . CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. Step 8 Learn from our experts through live events. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. 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