[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. [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. 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. The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). Also, monitor any other changes that may impact on the regulations. [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. For a more detailed look at the European regulatory process for medical devices, download the chart below. Medical Devices: Classes I, IIa, IIb and III. Meet our MDR team and get free educational resources on the MDR. Step 8 For Class I (non-sterile, non-measuring), annual NB audits are not required. [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]. All MDR CE-marked medical devices require recertification under the Regulation by May 2024. 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. 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. 16; Directive 90/385/EEC, supra note 2, art. [16] Id. [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. [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. It is based on the Title 21-CFR Quality System Regulations, which are defined for each device category. EU Parliament is fast-tracking changes to “New Approach” and the CE Mark approval process. The system will launch on March 25 th, 2020. [7]  Medical devices and in vitro medical devices produced in third countries (outside the EU) must conform with the EU legislation. View All. 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 aim of the MDR is to ensure compliance and consistency. A review of 338 AI-powered medical devices approved in Europe and in the United States reveals holes in the European review process. The EC Rep should be qualified to handle regulatory issues. Step 6 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. Clinical studies are required for Class IIb and III implants, though existing clinical data may be acceptable. 3, 2007 O.J. [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. View All. [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. Stringent, … 4. The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market. [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. 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 . EU countries. View All. 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). The regulation of medical devices does not fall within the scope of the European regulatory system for medicines. Download our MDR process chart. IVD Devices: Same as in the EU – List A & B, Self testing, all others. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? [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. Active implantable medical devices are typically subject to the same regulatory requirements as Class III 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. 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. [17] Commission Implementing Regulation (EU) No. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. However, you must perform CER updates and PMS activities. Failure to pass the audit will invalidate your CE Marking certificate. View All, Our global consulting team works from 20+ offices on six continents. 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. ... Stay up to date on the progress of the MDR through the regulatory approval process. Comprehensive service offerings at every point in the product life cycle. Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. 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. This includes certification, Notified Body and consultancy services. 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. 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. Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. 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 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. [15] Directive 93/42/EEC, supra note 3, Preamble. 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. WATCH NOW: Risk Management according to EN ISO 14971:2012, Europe CE Marking Regulatory Process for Medical Devices. 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 order to commercialize medical devices in the European Union, a CE Mark certificate is needed. 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. 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). ´MDD 90/385/EEC Active Implantable Medical Device Directive. 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. Approval Process for Medical Devices. Step 7 Step 3 Determine classification of your device … Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. [16]  Their accreditation and monitoring is conducted by the EU Members. [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. Step 10 If you do not have a location in Europe, appoint an Authorized Representative (EC Rep) located in Europe. Inspector General | The regulations were published in the Official Journal of the European Union on May 5th, 2017 and entered … 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: 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. However a PMS procedure is required, though not audited by a Notified Body (NB). You must perform CER updates and PMS activities. To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years (until 2022). The procedures required to legally place a medical device on the market vary in Canada, the US and the EU. This is a simplified overview of the process. Different regulatory bodies are involved, requiring different types of submissions (Table 1) and review timelines depending on the classification of the device.  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]. Manufacturers of Class I medical devices and general IVDs can self-declare their conformity against the EU MDD or EU IVDD as transposed by the UK MDR 2002 (as … [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. [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 products in each list contain information about … The EU first passed the Medical Device Regulation (EU MDR) in 2017 to replace the previous EU Medical Device Directive (MDD). Place EC REP name and address on Instructions for Use, outer packaging, or device label. ´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices . ´Classification of medical device… For a more detailed look at the European regulatory process for medical devices, download the chart below. Donate Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval. All Class I devices must be registered with the Competent Authority where you or your EC REP is based. Step 4 By working ... A consistent approach to medicines regulation across the European Union EMA medicines. We have deep expertise with a range of product types, including combination and borderline products. 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. 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. ´MDD 93/42/EEC Medical Device Directive. Accessibility | art. Most companies apply the ISO 13485 standard to achieve QMS compliance. 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.. Clinical trials in Europe must be pre-approved by a European Competent Authority. Most of these data should refer to the subject device. 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 devices require will require clinical data. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Step 9 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. [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. Step 1 You may now affix the CE Marking. Appropriate and effective evidentiary requirements for device approval is a serious problem for both the United States and EU. Overview of how the U.S. Food and Drug Administration’s approval processes for new medical devices varies from the European CE marking process. (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. 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. TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. CLASSIFICATION SYSTEM: Medical devices are classified according to risk, based on EU classes. 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. All medical devices placed onto the European market need to be subject to an appropriate post market surveillance process. Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) [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. Impact of October 22 plenary vote is reviewed and predictions made. These include creating a single, coordinated European system to oversee medical device approval and developing product standards. In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. [1] See Law Library Report for Congress: European Union Regulation of Medical Devices (LL File No. Appoint a Person Responsible for regulatory compliance. [3] Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. ´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR). 2011-005058) (Dec. 2010) (on file with author). September 2014. (L 247) 21, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system. [6] Directive 93/42/EEC, supra note 3, art. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1. All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Learn from our experts through live events. [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. [3]  In vitro diagnostic medical devices are governed by Directive 98/79/EC. 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. The CE mark is a legal requirement to place a device on the market in the EU. 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. [14] European Commission, supra note 11, at 2. The NMPA made revisions to its medical device classification catalog including the down-classification of 15... Resources and tools tailored to medical device professionals. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. CE Marking certificates are typically valid for 3 years. For economic and practical reasons, medical devices are subject to a graduated system of control, whereby the level of control corresponds to the level of danger inherent in the type of device involved. (L 331) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 L0079-20120111&rid=1. ISO 13485 certification must be renewed every year. About | 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 … The Medical Device Regulation (MDR) will replace … The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. ´CE Marking approval process. 2020 Device Approvals The products listed in this section include some of the newest medical technology from the year 2020. This long, exhaustive regulatory framework is used by medical device companies to attain the FDA market authorization. Device Application Process Because there is so much variation in the classification of devices, developers have a variety of options. Press | [21], Global Legal Research Directorate Staff Some EU member states require additional registration of Class IIa, IIb, or III devices that are placed on their markets. View All. CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. Get your first chart for free when you create a RAMS account. and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. What is the Medical Device Regulation (MDR)? Legal | For Classes I through IIb, prepare a Technical File that provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. [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. 11. 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. External Link Disclaimer | Implementation of the MDR began in May2017, with a three-year transition period ending May26, 2020. Jobs | 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. For Class I (non-sterile, non-measuring), a QMS is not formally required. According to the FDA regulations, companies follow requisite regulatory steps assessi… For Class III/AIMD devices, prepare a Design Dossier. Gain market access in Europe with CE mark. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF. 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. European Commission, supra note 3, Annex I. devices are classified according to risk, based the. 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