Step 8 A review of 338 AI-powered medical devices approved in Europe and in the United States reveals holes in the European review process. [6] Directive 93/42/EEC, supra note 3, art. 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. Step 5 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. [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. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF. Get your first chart for free when you create a RAMS account. 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. You may now affix the CE Marking. Overview of how the U.S. Food and Drug Administration’s approval processes for new medical devices varies from the European CE marking process. [7]  Medical devices and in vitro medical devices produced in third countries (outside the EU) must conform with the EU legislation. Inspector General | 11. ISO 13485 certification must be renewed every year. 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. 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 . [17] Commission Implementing Regulation (EU) No. Meet our MDR team and get free educational resources on the MDR. All Class I devices must be registered with the Competent Authority where you or your EC REP is based. ... Stay up to date on the progress of the MDR through the regulatory approval process. 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. On April 5th, 2017, the European Parliament approved the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/745 Article 117 and Regulation (EU) 2017/746, respectively) set by the European Medicines Agency (EMA). [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. Implementation of the MDR began in May2017, with a three-year transition period ending May26, 2020. Step 7 2011-005058) (Dec. 2010) (on file with author). The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. 16; Directive 90/385/EEC, supra note 2, art. For Class III/AIMD devices, prepare a Design Dossier. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. Step 10 In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. art. According to the FDA regulations, companies follow requisite regulatory steps assessi… All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). 2020 Device Approvals The products listed in this section include some of the newest medical technology from the year 2020. [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. The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. The system will launch on March 25 th, 2020. This long, exhaustive regulatory framework is used by medical device companies to attain the FDA market authorization. TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. EU Parliament is fast-tracking changes to “New Approach” and the CE Mark approval process. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Impact of October 22 plenary vote is reviewed and predictions made. Also, monitor any other changes that may impact on the regulations. Press | (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. [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. Step 9 Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) 4. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1. Most companies apply the ISO 13485 standard to achieve QMS compliance. Step 4 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. View All. 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. Accessibility | [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]. 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. ´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR). The procedures required to legally place a medical device on the market vary in Canada, the US and the EU. This includes certification, Notified Body and consultancy services. Device Application Process Because there is so much variation in the classification of devices, developers have a variety of options. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. For Class I (non-sterile, non-measuring), annual NB audits are not required. The EU first passed the Medical Device Regulation (EU MDR) in 2017 to replace the previous EU Medical Device Directive (MDD). Appoint a Person Responsible for regulatory compliance. CLASSIFICATION SYSTEM: Medical devices are classified according to risk, based on EU classes. It is based on the Title 21-CFR Quality System Regulations, which are defined for each device category. The regulation was published on 5 May 2017 and came into force on 25 May 2017. The regulation of medical devices does not fall within the scope of the European regulatory system for medicines. In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. For a more detailed look at the European regulatory process for medical devices, download the chart below. The Medical Device Regulation (MDR) will replace … On 23 April 2020, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period of the Medical Devices Regulation by one year - until 26 May 2021. The approval process for medical devices follows a certain pattern: Authorities select legally and technically independent, competent bodies called Notified Bodies to independently check that manufacturers are conforming to …  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. You must perform CER updates and PMS activities. For all devices except Class I (non-sterile, non-measuring), implement Quality Management System (QMS) in accordance with Annex II or V of the MDD. ´Classification of medical device… [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. [2] Council Directive 90/385/EEC of 20 June 1990 on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, 1990 O.J. [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. September 2014. Most of these data should refer to the subject device. To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years (until 2022). This is a simplified overview of the process. Clinical studies are required for Class IIb and III implants, though existing clinical data may be acceptable. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. WATCH NOW: Risk Management according to EN ISO 14971:2012, Europe CE Marking Regulatory Process for Medical Devices. View All, Our global consulting team works from 20+ offices on six continents. About | ´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices . Appropriate and effective evidentiary requirements for device approval is a serious problem for both the United States and EU. All MDR CE-marked medical devices require recertification under the Regulation by May 2024. ´MDD 90/385/EEC Active Implantable Medical Device Directive. For all other classes, you will be audited each year by a Notified Body to ensure ongoing compliance with 93/42/EEC or 90/385/EEC. For Classes I through IIb, prepare a Technical File that provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. 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. [20] EU Parliament Stops Short of U.S.-Style Approvals for Medical Devices, Reuters (Oct. 22, 2013), http://www.reuters.com/article/2013/10/22/us-eu-medtech-idUSBRE99L0TH20131022. The aim of the MDR is to ensure compliance and consistency. 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. 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. (L 247) 21, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf. IVD Devices: Same as in the EU – List A & B, Self testing, all others. Failure to pass the audit will invalidate your CE Marking certificate. The CE mark is a legal requirement to place a device on the market in the EU. Determine classification of your device … [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. [3]  In vitro diagnostic medical devices are governed by Directive 98/79/EC. ´MDD 93/42/EEC Medical Device Directive. 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. Comprehensive service offerings at every point in the product life cycle. Medical Devices: Classes I, IIa, IIb and III. [15] Directive 93/42/EEC, supra note 3, Preamble. 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. 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. Stringent, … The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market. What is the Medical Device Regulation (MDR)? CE Marking certificates are typically valid for 3 years. By working ... A consistent approach to medicines regulation across the European Union EMA medicines. [1] See Law Library Report for Congress: European Union Regulation of Medical Devices (LL File No. [14] European Commission, supra note 11, at 2. All devices require will require clinical data. The products in each list contain information about … Official blog from the Law Library of Congress, The current European Union (EU) regulatory framework governing medical devices[1] includes Council Directive 90/385/EEC on Active Implantable Medical Devices[2] and Council Directive 93/42/EEC on Medical Devices. 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: Approval Process for Medical Devices. [5] Boston Consulting Group, Regulation and Access to Innovative  Medical Technologies: A Comparison of the FDA and EU Approval Processes and Their Impact on Patients and Industry (2012), http://www.eucomed.org/uploads/ModuleXtender/Newsroom/97/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf. Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. [3] Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval. [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. EU countries. Step 6 3, 2007 O.J. [19], A number of Member States urged the Parliament to establish a centralized EU premarketing approval process along the lines of the US system.  It appears that the Parliament has not introduced such a procedure. This measure aims to avoid shortages of medical devices during the ongoing COVID-19 pandemic due to the limited capacity of national competent authorities or notified bodies to implement the Regulation. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system. For a more detailed look at the European regulatory process for medical devices, download the chart below. Place EC REP name and address on Instructions for Use, outer packaging, or device label. Urs Muehlematter, Paola Daniore and Kerstin Vokinger, all from of the University of Zurich, published a study on the approval processes of medical devices that use Artificial Intelligence or Machine Learning. The regulations were published in the Official Journal of the European Union on May 5th, 2017 and entered … Clinical trials in Europe must be pre-approved by a European Competent Authority. (L 331) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 L0079-20120111&rid=1. [21], Global Legal Research Directorate Staff We have deep expertise with a range of product types, including combination and borderline products. A medical device manufacturer needs to have a pro-active surveillance system in place, which will include monitoring customer feedback, identifying investigating and addressing complaints, complaint trending, the implementation of an effective and efficient corrective and preventative action process, … 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. A superb example was the European Society of Cardiology's recent release of a consensus document that suggests several reforms for the outdated European medical device approval process. [12] Directive 93/42/EEC, supra note 3, Annex I.Â. ´CE Marking approval process. Donate Jobs | 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. 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. Different regulatory bodies are involved, requiring different types of submissions (Table 1) and review timelines depending on the classification of the device. 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. Learn from our experts through live events. View All. 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 1 The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. However, you must perform CER updates and PMS activities. Gain market access in Europe with CE mark. [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. These include creating a single, coordinated European system to oversee medical device approval and developing product standards. 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.. [11] European Commission, DG Enterprise, Guidelines for the Classification of Medical Devices 4, meddev 2.4/1 Rev. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. The EC Rep should be qualified to handle regulatory issues. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). View All. [4]  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.  At the EU level, there is no centralized approach similar to that in the United States. All medical devices placed onto the European market need to be subject to an appropriate post market surveillance process. Active implantable medical devices are typically subject to the same regulatory requirements as Class III 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. 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. 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