The products in each list contain information about … 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. [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. Legal | Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. Get your first chart for free when you create a RAMS account. Step 5 [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. 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.  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]. ISO 13485 certification must be renewed every year. According to the FDA regulations, companies follow requisite regulatory steps assessi… If you do not have a location in Europe, appoint an Authorized Representative (EC Rep) located in Europe. Device Application Process Because there is so much variation in the classification of devices, developers have a variety of options. CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. [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. A review of 338 AI-powered medical devices approved in Europe and in the United States reveals holes in the European review process. Jobs | 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 . [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. Most companies apply the ISO 13485 standard to achieve QMS compliance. 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. [21], Global Legal Research Directorate Staff It is based on the Title 21-CFR Quality System Regulations, which are defined for each device category. The EU first passed the Medical Device Regulation (EU MDR) in 2017 to replace the previous EU Medical Device Directive (MDD). For a more detailed look at the European regulatory process for medical devices, download the chart below. Step 4 September 2014. [12] Directive 93/42/EEC, supra note 3, Annex I.Â. The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. IVD Devices: Same as in the EU – List A & B, Self testing, all others. Implementation of the MDR began in May2017, with a three-year transition period ending May26, 2020. CLASSIFICATION SYSTEM: Medical devices are classified according to risk, based on EU classes. The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Download our MDR process chart. ´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR). Impact of October 22 plenary vote is reviewed and predictions made. [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. [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. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. 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. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval. WATCH NOW: Risk Management according to EN ISO 14971:2012, Europe CE Marking Regulatory Process for Medical Devices. [16] Id. [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 all devices except Class I (non-sterile, non-measuring), implement Quality Management System (QMS) in accordance with Annex II or V of the MDD. This includes certification, Notified Body and consultancy services. Inspector General | 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. View All. 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. Accessibility | 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. (L 331) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 L0079-20120111&rid=1. 2011-005058) (Dec. 2010) (on file with author). ´Classification of medical device… 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. 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. In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. [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]. TIMEFRAME: The registration process in the EU takes about 4-6 weeks after submission for Class I devices. 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. For a more detailed look at the European regulatory process for medical devices, download the chart below. Clinical studies are required for Class IIb and III implants, though existing clinical data may be acceptable. Step 10 All Class I devices must be registered with the Competent Authority where you or your EC REP is based. 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 … [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. To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years (until 2022). Some EU member states require additional registration of Class IIa, IIb, or III devices that are placed on their markets. 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. [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. The aim of the MDR is to ensure compliance and consistency. The regulation of medical devices does not fall within the scope of the European regulatory system for medicines. Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. 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. ´MDD 90/385/EEC Active Implantable Medical Device Directive. View All. You may now affix the CE Marking. This is a simplified overview of the process. [11] European Commission, DG Enterprise, Guidelines for the Classification of Medical Devices 4, meddev 2.4/1 Rev. 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. This long, exhaustive regulatory framework is used by medical device companies to attain the FDA market authorization. [16]  Their accreditation and monitoring is conducted by the EU Members. Different regulatory bodies are involved, requiring different types of submissions (Table 1) and review timelines depending on the classification of the device. The regulation was published on 5 May 2017 and came into force on 25 May 2017. 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. Interested in CE Marking under the new EU Medical Device Regulation (MDR 2017/745)? Step 8 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.. 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). 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). These include creating a single, coordinated European system to oversee medical device approval and developing product standards. 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. [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. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF. and thought it would be a good idea to just lay out how the European approval process for medical devices actually works. Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. Learn from our experts through live events. Step 6 Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. Active implantable medical devices are typically subject to the same regulatory requirements as Class III devices. Last month I wrote a blog on pre-market authorisation (and why this approach does not work for devices!) [6] Directive 93/42/EEC, supra note 3, art. (L 247) 21, http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf. 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. About | Press | View All, Our global consulting team works from 20+ offices on six continents. Donate The Directives outline the safety and performance requirements for medical devices in the European Union (EU). For Class III/AIMD devices, prepare a Design Dossier. [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. ´CE Marking approval process. External Link Disclaimer | CE Marking certificates are typically valid for 3 years. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. [20]  The proposal is expected to be adopted in 2014 and would gradually be implemented between 2015–2019. It might be a bit ‘dry’ but at least after reading this post you’ll understand the mechanics of the European system. The procedures required to legally place a medical device on the market vary in Canada, the US and the EU. ´MDD 93/42/EEC Medical Device Directive.