European commission medical devices Provides assistance on all implementation issues related to the medical device nomenclature with the aim to support the functioning of the future European database on medical devices (EUDAMED). These are Latest updates News announcement Medical devices are products or equipment intended for a medical purpose. 55078125) Download PDF rendition (1251. 28 April 2021. Introduction This document is intended to provide Commission guidance for expert panels established under Article 106 of Regulation (EU) 2017/745 (1) of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR). 1 - Guidance on standardisation for medical devices - July 2024 Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Sector: the Medical Devices sector is defined through the description of current legislation for EU market and the definition of challenges taken as a target; New Regulations: the new legislation that will be applicable within the EU is defined . Factsheet for Class I - Medical Devices. Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; B10‑0125/2024. The European Medicines Agency (EMA) published a draft guideline and commenced consultations on the implementation of EU MDR Article 117 related to drug-device combinations. The consultation provides stakeholders with the opportunity to express their views on how the current rules are performing and to highlight possible shortcomings. (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici’(CND) as the basis for the EMDN. English (1. In its Conclusions, the Council requested the Commission to adapt the EU medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent and sustainable regulatory Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; News announcement; 15 April 2024; Directorate-General for Health and Food Safety; 1 min read; MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024 Today, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The European regulation for medical devices (Medical Device Regulation, MDR) became applicable on 26 May 2021. 3 (32 kB) Committees/working groups contributing to the implementation of the medical device directives Regulation (EU) 2022/112, of 25 January 2022, amended the transitional provisions of Regulation (EU) 2017/746, extending them in scope and timing. The study started in December 2022 and will be running for 36 months (December 2025). Useful information. to the Medical Devices 1 section on the on the European Commission website2. New lists of harmonised standards for medical devices available. the Council requested the Commission to adapt the EU medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent and sustainable regulatory Several structures exist that allow for the coordination between various parties, for example the Medical Devices Coordination Group (MDCG), established by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices with specific obligations and rules, the Notified Body Coordination Group - Detailed information on national rules are available on the page National rules on reprocessing of single-use devices. 52 MB - PDF) Download. Publication date. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Guidance The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, COM(2022)182 final of 26 April 2022. The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives. Often, they are used to treat a rare disease or medical condition Union on innovation in the medical device sector adopted on 6 June 20117. Medical devices Regulation (MDR) Newsletter issue of 26/03/2021 In this issue of the newsletter find the latest available guidance to help you prepare for the new Regulations, particularly within the context of the COVID-19 pandemic and the The Commission approved requests from all EU countries and the UK to temporarily waive customs duties and VAT on the import of medical devices, and protective equipment, from third countries. The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746. Details. Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices are developed by CEN and CENELEC as European standardisation organisations, on the basis of a standardisation request issued by the Commission according to Regulation (EU) No 1025/2012. • Regulation (EU) 2017/745 on medical devices (MDR) • applicable since 26 May 2021, plus extra transitional period for ‚legacy devices‘ • Regulation (EU) 2017/746 on conditions for in-house devices. More information: Medical Devices - Sector - European Commission In January 2024, in the context of the ‘Study supporting the monitoring of availability of medical devices on the EU market’, the Commission developed a dashboard presenting an overview of the data gathered from different stakeholders. 2 (August 2024) Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the European Parliament and the Council. The new medical devices Regulation (2017/745/ EU) (MDR) and the new in vitro diagnostic medical devices Regulation (2017/746/EU) (IVDR), entered into force in May 2017, will replace the existing medical devices Directive (93/42/EEC) (MDD), the active implantable You can use the filters to search for Devices, Systems and/or Procedure Packs (SPP) registered in EUDAMED, or, in the case of Competent Authorities and Notified Bodies, those submitted or discarded: Once you have entered your search filters, click on Search (the record will have to match all the filters). Related Documents. This is an important step that will help address the short-term difficulties Member States are facing and ensure a continued access to needed medical devices for patients in the EU. Regulation (EU) 2024/1860, of 13 June 2024, further extended the transitional periodsrovisions of Regulation (EU) 2017/746, subject to certain The European Database on Medical Devices (EUDAMED), the IT system introduced to assist with the implementation of the regulations, is intended to be a central repository of information on the medical devices available on the EU market. Update - MDCG 2021-5 Rev. Released by the Commission services in January 2012 (and updated in July 2016), the document provides practical advice to manufacturers, organisations and public authorities on how to determine when a software falls under the definition of a medical device or of an in-vitro diagnostic medical device. Applicable from 26. 12/1 rev. These regulations introduce important improvements such as stricter control for high-risk devices via a new pre Today, the European Commission has published guidance on the clinical evaluation of orphan medical devices. Once their references are published by the Commission in the The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. As of today, new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. 2021. European Medical Device Nomenclature (EMDN) aims at supporting the functioning of Note: The European Commission held a month- long online consultation on the English version of the European Medical Device Nomenclature (EMDN) with a deadline of 4 June 2021. In order to fulfil reporting requirements under The Medical Devices Regulation was approved together with the Regulation on In-Vitro Diagnostic Devices, which will apply from 26 May 2022. These two decisions focused on updating the list of harmonized standards. . 1 (1) Commission Regulation (EU) 2021/2045 (2) amending Annex XIV to Regulation (EC) No 1907/2006 sets 27 May 2025 as sunset date and 27 November 2023 as latest application date for uses of the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. 2021 Commission has proposed to update the rules to improve the safety of medical devices, with a view to modernise the sector and to consolidate the EU's role as a global leader in this area. OJ L 117 of 5 May 2017. Intensive preparations continue for the full roll-out of the new medical devices Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR). 2. It was established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. On 22 March 2023, the European Commission published the proposal for a directive on ‘common rules Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021 Today, the Council of the European Union has adopted the Commission's proposal to give notified bodies and manufacturers more time to certify medical devices and thereby mitigate the risk of shortages. These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks. HaDEA has published the EU4Health call for tenders HADEA/2024/OP/0024- horizon scanning for medical devices & in vitro diagnostic medical devices. 4 October 2021. , class D devices. Amendment to harmonized standards in EU Medical Device Regulations. Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. D. 3 - Publication date: n/a - Last update: Fri Mar 08 16:35:10 CET 2024 News announcement; 25 June 2024; Directorate-General for Health and Food Safety; 1 min read; MDCG 2024-10 - Clinical evaluation of orphan medical devices - June 2024 Commission Implementing Regulation (EU) 2022/20 of 7 January 2022, laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. These particles (nanoparticles) exhibit specific characteristics that 1 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medical Products and Innovation Medical Devices MDR - Language requirements for manufacturers - Rev. 3) Factsheet for manufacturers of in vitro diagnostic medical devices. It is created to register all medical devices placed on the European Union market, thereby offering a broad and detailed overview of the devices available on the EU market. European Commission. Eudamed2 is the European Databank on Medical Devices. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i. MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024) MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024) Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Languages on our On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation International Cooperation Public safety and healthcare are among the main The Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council was adopted on 5 Apr il 2017 (1). News – having regard to the Commission’s proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010), A clinical trial of a medicinal product in parallel with a clinical investigation of a medical device; The ‘COMBINE’ project. medical device directive, article 10 (213 kB) January 2007 MEDDEV 2. This was intended to provide the basis of the EU’s future identification and traceability infrastructure, in line with the latest developments at international level. , no ‘sell-off' date). Factsheet for manufacturers of in vitro diagnostic medical devices Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Regulation (EU) 2017/745 on medical devices - Summary list as pdf document Document date: Wed Jan 05 00:00:00 CET 2022 - Created by GROW. Implementing act on joint clinical assessment of medical devices and in-vitro diagnostic medical devices – in preparation; Latest updates. A range of guidance documents assist stakeholders in implementing the medical devices regulations. 29 April 2021. The transition timelines were amended on the initiative of the European Commission in October 2021, also due to COVID-19. More than 500,000 different types of medical devices available: wheelchairs, glasses, pacemakers, implants, mobile phone apps, or surgical equipment. 8: Download native rendition (762. The MDCG advises and assists the Commission and EU countries in Medical device expert panels deliver the advice on request from the European Commission, the Medical Device Coordination Group (MDCG), national competent authorities in EU Member States, manufacturers, and notified bodies if needed. December 2019: A second corrigendum to Regulation (EU) 2017/746 was published in the Official Journal of the European Union. Implementing Decision (EU) 2024/815 amending Implementing Decision (EU) 2021/1182 as regards harmonized The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules. The Commission shall be assisted by the Committee set up by Article 6 (2) of Directive 90/385/EEC. To achieve this, the Commission regularly liaises with patient and industry associations to explore ways of bringing innovation to patients while helping enterprises and maintaining growth. This opinion assesses whether the use of bisphenol A in medical devices such as implants, catheters, and dental devices could give reasons for safety concerns, to provide indications on limit values for BPA release from medical devices and to identify any patient group, e. The call aims to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up ­to ­date overview of new and emerging technologies. FAQs on sanctions against Russia and Belarus, with focus on the following provisions: Articles 2, 2a, 3k, 3l, 3ea and 5aa of Council Regulation (EU) No 833/2014. The European Commission has decided on its own initiative to initiate, pursuant to Article 5(1) of Regulation (EU) 2022/1031, an investigation into alleged measures and practices of the People’s Republic of China (‘PRC) resulting in a serious and recurrent impairment of access of Union economic operators, goods and services to the PRC’s public procurement market for The evaluation will also consider the impact that the rules have on the availability of devices, including ‘orphan devices’ and on the development of innovative devices. of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the European Commission Medical Devices website: Summary list of titles and references of harmonised standards 3 All MDCG Guidance documents can be found on the European Commission Medical Devices website: Guidance documents. Author Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) aim to ensure that safe and performant medical devices are being placed on the EU market while supporting innovation. e. The MDR replaces the earlier European Directives for medical devices (93/42/EEC) and for active implantable medical devices (90/385/EEC). Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022, covering devices detecting and/or quantifying HIV, human T-cell lymphotropic virus, hepatitis B, C Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives. The Commission’s expert panels on medical devices and in vitro diagnostic medical devices will be handed over to the European Medicines Agency (EMA). This new regulatory framework sets high standards of quality and safety for medical devices and aims At least one national derogation has been granted and notified to the Commission for the medical device in question The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). The Medical Devices Regulation entered into force in May 2017 and becomes applicable on 26 May Enhancing competitiveness while ensuring the safety and performance of medical devices is a key objective of the European Commission. 1 - Guidance on standardisation for medical devices - July 2024. 15 rev. The Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed arrangements necessary for the By Commission Implementing Decision C(2021) 2406 (5), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revision of existing harmonised standards on medical devices developed in support of Directives 90/385/EEC and 93/42/EEC and the European Union > European Commission > Directorate-General for Health and Food Safety > Deputy Director General for Health responsible for Directorates B, C and D > Medical Products and Innovation > Medical Devices (SANTE. Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. 1 Page 1 of 27 MDCG 2021-5 Rev. Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common Stronger rules on medical devices; News announcement; 26 May 2021; Directorate-General for Health and Food Safety; 1 min read; Stronger rules on medical devices. 2. This guidance aims to ensure a consistent interpretation of the criteria to be applied when deciding whether or not to Eudamed2 - European Databank on Medical Devices. Products used for control or support of conception, and cleaning / sterilization of medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES, Committee on Medical Devices. pdf. Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) were adopted in April 2017 and entered into force on 25 May 2017. 05. See MDCG 2021-3 - Questions and Answers on Custom-made devices & considerations on adaptable medical devices and Patient-matched medical devices The European Commission has initiated a public consultation and call for evidence regarding EU legislation on medical devices and in vitro diagnostic medical devices. devices' risk class and will ensure continued access to medical devices for patients. Moreover, common specifications are adopted for particular types of devices. The original five-year transition period for different types of in-vitro diagnostic For these reasons, the Medical Device Coordination Group (MDCG), composed of representatives of all EU Member States and chaired by a representative of the European Commission, at its meeting in October 2023 asked its members to provide the information on their national language requirements, resulting in the publication of the two tables on the 53rd CAMD meeting statement . The consultation and call for evidence will be open until 21 March 2025 and are accessible here. Its findings revealed the following Disclaimer: Currently only the Actor, the UDI/Device and the Notified Bodies and Certificates modules are available. This allows for progressive roll-out ofa staggered transition to the new framework. 1 Guidance on standardisation for medical devices Revision 1 – July 2024 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. What You Need to Know About Regulation (EU) 2017/745. European Commission - Press release Public health: Stronger rules on medical devices Brussels, 26 May 2021 As of today, new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. 1. This targeted evaluation aims to assess the effectiveness of the current regulations, examining their costs, administrative burdens—particularly for SMEs—and benefits for patients and users. The EU Today, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation to prevent disruption in the supply of these essential healthcare products. On the basis of the Commission proposal in January 2024, on 25 April 2024 the European Parliament adopted a new amendment to Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as regards a gradual roll-out of the European database on medical devices (Eudamed), the obligation to inform in case of Chair: European Commission. In-house medical devices Health institutions have The Commission and Member States have created MDR and IVDR tables. This guidance aims to ensure a consistent interpretation of the criteria to be applied when deciding THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 For cer tain in vitro diagnostic medical devices, Regulation (EU) 2022/112 of the European Parliament and the Council (8) has Medicines and medical devices. Please refer to Article 2(1) of the regulation (Regulation 2017/745). Relevant contacts for the medical devices sector, including Competent Authorities and stakeholders are publicly available. News announcement; 13 April 2022; Directorate-General for Health and Food Safety; 1 min read; Notice to Stakeholders: EU-Türkiye Customs Union Agreement in the field of medical devices of health care products and biological evaluation of medical devices THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone by one year the date of application of the Medical Devices Regulation. The general application dates of the Eudamed is an essential element of the medical device regulatory framework and is a major step forward in ensuring traceability and transparency in medical devices. Additional national requirements on registrations can therefore not be excluded. infants, pregnant and breastfeeding women who would be particularly at risk. The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’). Nomenclature – Terms of reference. of the handover is the extended mandate of EMA on crisis preparedness and management of medicinal products and medical devices (Regulation (EU) 2022/123), developed as a reaction to the European Commission; DocsRoom; Document detail; Available translations Language Title Keywords Native rendition Pdf rendition; EN: Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2. HORIZON-HLTH-2024-IND-06-08 - Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs). Factsheets The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. See references published under Regulation This page lists the opinions provided under the Clinical Evaluation Consultation Procedure (CECP, see Article 54 of Regulation (EU) 2017/745) by each thematic expert panel in the field of medical devices. In addition, comparable data from previous surveys of notified bodies conducted by the Commission have been Medical Devices Medical Device Coordination Group Document MDCG 2021-5 Rev. DG HEALTH AND CONSUMER . The Commission also published specialised guidance to ease the work of EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices. This site is managed by: Directorate-General for Health and Food Safety Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 set outs the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, notified bodies establish lists of their standard fees for the The Medical Device Coordination Group (MDCG) is an expert group. The rolling plan below contains a list of key activities that the European Commission has carried out or intends to carry out in preparation for the implementation of Regulation (EU) 2021/2282. This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an With over 500 000 types of medical device and IVD – ranging from sticking plasters to X-ray machines – on its market, the EU has a competitive and innovative medical device sector, characterised by many small and medium-sized enterprises. R. 15 Other guidance MEDDEV 2. Factsheet for Manufacturers of Implantable Medical Devices Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an 1. The EU Regulations on medical devices and . 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024 This includes adapted versions of devices that are mass-produced through industrial manufacturing according to written instructions by an authorised person. European Parliament resolution on the urgent need to revise the Medical Devices Regulation (2024/2849(RSP))The European Parliament, – having regard to Article 168 of the Treaty on the Functioning of the European Union, which provides that ‘a high level of human health protection shall be ensured in the definition and implementation of all Union policies and European Commission publishes new Regulation (EU) 2024/1860; Regulations for medical devices. COMMISSION IMPLEMENTING REGULATION (EU) 2024/2699. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. This issue of the Medical Devices newsletter updates you Factsheet for manufacturers of medical devices. Examples include hospitals, but also laboratories and public health institutes that support the healthcare system and/or address patient needs, but do Factsheet for Class I - Medical Devices. The aim was to collect feedback from users andthe wider healthcare News announcement; 8 July 2024; Directorate-General for Health and Food Safety; 1 min read; MDCG 2020-16 Rev. EUROPEAN COMMISSION . 12. The EURLs have two main categories of tasks: advisory ones and those related to conformity assessment, particularly of the highest risk, i. The ‘COMBINE’ initiative aims to: European Commission (EC) Documents TOPIC Title Author MD Manufacturers Factsheet for Manufacturers of Medical Devices EC Implementation Model for Medical Devices Regulation Step by Step Guide EC MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES EC IVD Manufacturers step by step Implementation Model for In-Vitro EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics GUIDELINES ON MEDICAL DEVICES please be aware that the European medical device directives pre-date the split in the terminology. They are not legally binding. Author Directorate-General for Health and Food Safety. 9541015625) Last Regulation (EU) 2017/745 on medical devices and Regulation The Commission is not in a position to require the use of the UDI/Device registration module until the transition periods laid down in Regulation (EU) 2024/1860 expire. (Commission Recommendation 2011/969/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial. The European Commission’s Medical Device Coordination Group (MDCG) undertook a survey on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR). Applicable Ministers, The Medical Devices Regulation, adopted by the European Parliament and the Council in 2017 and after more than 4 years of hard negotiations, followed a series of severe scandals that put pa This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic medical devices (IVDMD) sec. The Spanish Presidency of the Council of the European Union held the 53rd meeting of the EU Competent Authorities for Medical Devices (CAMD) on the 19-20 of September 2023, in Santiago de Compostela, Spain. Share this page Contact the European Commission; Follow the European Commission on social media; Resources for partners; Report an IT vulnerability; Factsheet for Class I - Medical Devices; News announcement; 28 April 2021; Directorate-General for Health and Food Safety; Factsheet for Class I - Medical Devices. g. The new rules start applying after a New EU rules to ensure safety of medical devices Brussels, 5 April 2017 European Commission - Fact Sheet People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. The Member States’ competent authorities for clinical trials and medical devices and the European Commission launched this initiative in June 2023. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitro diagnostic devices (IVDs), listed in The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 26 May 2021: Medical Devices Regulation; 26 May 2022: In Vitro Diagnostic Medical Devices Regulation COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. According to MedTech Europe figures, over 15,900 patent applications for medical devices were filed in 2023 with the European Patent Office – roughly one new application every 30 minutes, in a This applies specifically to medical devices manufactured and used strictly in health institutions. The legal basis is the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic In 2012, the European Commission issued two proposals for Regulations (on medical devices, and in vitro medical devices ) to modernise this framework in order to keep pace with technological advances, improve safety and traceability of devices, and ensure greater transparency including towards patients and the general public. The availability of safe medical devices for European patients is our The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. Participants: Competent authorities, stakeholders. Dedicated factsheets provide a summarised view of the main areas of activities in the medical devices sector. EUDAMED will contain a living picture of the lifecycle of all products being available on the EU market. The European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) Guidance There are a number of guidance documents endorsed by the Medical Device Coordination Group to assist stakeholders with the implementation of the medical device regulations The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices for the European market. This revised timeline will provide more flexibility to industry for the ongoing certification of needed medical devices and reduce short-term risks of shortages. Directorate B, Unit B2 “Cosmetics and medical devices” MEDICAL DEVICES: The present MEDDEV is part of a set of guidelines relating to questions of application of EU Directives on medical devices. The Commission draws up an annual overview of devices which have been subject to the CECP. Read our article on European Commission Newsletter on medical devices | May 2023 and view more articles in our library of regulatory updates, medical device certification information The Commission issued a recommendation in April 2013 on a common framework for a unique device identification system for medical devices in the EU. It also contributes to a uniform application of the Directives. The work on IVDs is also supported by guidance documents endorsed by the Medical Device Coordination Group. EMA has worked closely with the European Commission MDCG 2021-24 - Guidance on classification of medical devices. These are legally non-binding guidance documents, whose main purpose is ensuring uniformity in the application of the regulations The European Commission has adopted several implementing measures based on the medical devices directives. The Council has adopted a regulation amending the rules governing medical devices and in-vitro diagnostic medical devices, with a view to preventing shortages. 1 DECEMBER 2021; mdcg_2021-24_en. Within the ongoing “Study supporting the monitoring of availability of medical devices on the EU market”, the European Commission has launched a survey for MD and IVD economic operators, in particular manufacturers and authorised representatives, to obtain information about the implementation of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) The European Commission published MDCG 2019-16, Guidance on Cybersecurity for medical devices, including IVD medical devices. 3 – Medical Devices. The representative of the Commission shall submit to the Committee a draft of the measures to Factsheet for Manufacturers of Implantable Medical Devices. 25 March 2020. DIR - Publication date: n/a - Last update: Mon Jun 22 08:59:30 CEST 2020 This site is managed by: Directorate-General for Health and Food Safety On 6th March, the EU Commission published Decision EU 2024/817 and Decision EU 2024/815. On 23 January 2024 the European Commission published a proposal to update the provisions of the IVDR and MDR with the aim of mitigating shortages of critical medical devices. 1 min read; See all medical devices, the Commission held two public consultations, the first from 8 May to 2 July 2008, and the second from 29 June to 15 September 2010. 14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012 2. Its members are experts representing competent authorities of the EU countries. The current rules on the safety and performance of medical devices in the EU were harmonised in the 1990s. The temporary waiver has been extended again until 31 December 2021. H. In accordance with Article 56(1) of Regulation (EC) No 1907/2006, such uses of DEHP are not Regulation (EU) 2022/112 and Regulation (EU) 2024/1860 amended the transitional rules, allowing for a staggered transition the new framework. Directorate-General for Health and Food Safety (DG SANTE) Unit D. The new rules Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) are aimed at ensuring Work Practical information for experts Medical Devices Medical Device Coordination Group Document MDCG 2021- 24 4 1 Purpose of medical device classification The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. In the future, when all modules will be released and mandatory to use all functionalities shown in the videos will be available. Only the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council MDCG 2019-16 - Guidance on Cybersecurity for medical devices Document date: Mon Jan 06 00:00:00 CET 2020 - Created by GROW. Medical Devices Medical Device Coordination Group Document MDCG 2023-3 Rev. EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 This page provides a range of documents to assist stakeholders in applying: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. dxe kexnq vuw oduqy mcxjk jhhujy bxl vomqnk czy jrsttctj