The Commission submitted a proposal on 6 January 2023, which was negotiated by the European Parliament and the Council in an urgency procedure. Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) are aimed at ensuring…. Jun 5, 2020 · According to Article 54 (4) of Regulation (EU) 2017/745 the Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5. Common specifications are detailed practical rules setting out how particular types of devices should comply with certain requirements of Regulation (EU) 2017/746. Its members are experts representing competent authorities of the EU countries. Amendment of 6 January 2022 to Implementing Decision (EU) 2021/1195. Factsheet for Class I - Medical Devices. 26 May 2021: Regulation (EU) 2017/745 on medical devices. Active therapeutical device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap13. EUDAMED is integral part of the implementation of the two Medical Devices Regulations. Jan 7, 2019 · Regulation (EU) 2019/6 on veterinary medicinal products. 1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998. In a 2023 report , the European Chamber of Commerce in China warned that “European companies were disadvantaged by opaque approval processes and China’s centralized volume-based procurement directive, as well as the government’s continued provision of Eudamed2 is the European Databank on Medical Devices. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. 18 KB - PDF) Download. This site uses cookies. The European Commission supports EU countries, which have public safety and healthcare amongst its main responsibilities. 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 (Text with EEA relevance. Directive 93/42/EEC, as amended, allows for derogation from the 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. Jan 23, 2024 · Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. This new regulatory framework sets high standards of quality and safety Nov 27, 2023 · Under paragraph 16 of the explanatory memorandum to the proposed regulation, the European Commission must, when establishing ecodesign requirements for medical devices, ‘take into account of the need to not negatively affect health and safety of patients and users’. The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation . Medical devices. Other languages (23) Factsheet for manufacturers of medical devices. Mar 12, 2024 · MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) News announcement 12 March 2024 Directorate-General for Health and Food Safety 1 min read Feb 21, 2023 · European Union, United Kingdom February 21 2023. Jan 23, 2024 · On 17th January 2024, the European Commission published the overview of language requirements for the product information and instructions to be provided with medical devices (MD) and in vitro diagnostic devices (IVD) in the European Union. Apr 24, 2024 · Scope: Medical devices. Overview. 1 of Annex IX and referred to in Section 6 of Annex X and shall submit this overview to the European Parliament, to the Council and to the MDCG. 26 May 2022: Regulation (EU) 2017/746 on in vitro diagnostic medical devices. 10. Final text agreed with the European Parliament on amending the Medical Devices Regulation and In Vitro Diagnostic Committee on Medical Devices. Susan Kelly Reporter. Activities focused on medical device software and AI Aug 24, 2022 · Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 258, 20. See full list on health. Harmonised Standards. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) 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”. With this revision, the Commission aims to ensure patient care by improving the availability of these essential healthcare products. Jan 13, 2015 · The SCENIHR Opinion is intended as guidance how to evaluate the risk when a nanomaterial is used in a medical device. Other languages (23) Factsheet for Class I - Medical Devices. By. HADEA. 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 Regulation - 2017/745 - EN - Medical Device Regulation - EUR-Lex. MEDDEV 2. ec. The UDI Helpdesk is live. 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. The MDCG is composed of representatives of all Member States and it. Chair: European Commission. 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 efforts to manage it and mitigate its impacts. 1. The European Commission is active in a number of policy and regulatory dialogues with Oct 17, 2023 · Amendment to harmonized standards in EU Medical Device Regulations. 2021, pp. The Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed Apr 24, 2024 · European firms have meanwhile long deplored China’s closed medical devices market. The Proposal will now be put forward to the European Parliament and Council for adoption. 2. The Medical Device Coordination Group (MDCG) is an expert group. The Commission draws up an annual overview of devices which have been subject to the CECP. The European Commission can adopt common specifications where. It is created following a request from the European Commission to one of these organisations. The Action Plan for Immediate Actions under Existing Medical Devices Legislation was launched in 2012 following the discovery of the fraudulent use of non-medical grade silicone in breast implants that were manufactured by the company 'Poly Implant Prothèse' (PIP). The EU Council agreed on its mandate on 14 February 2024. dental filling composites), free nanomaterials added to a medical device (e. Active device for diagnosis: Common specifications. April 2021- June 2022 Jan 25, 2022 · Regulation (EU) 2022/112 , of 25 January 2022, amended the transitional provisions of Regulation (EU) 2017/746 , extending them in scope and timing. By 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 drafting MDCG 2020-16 Rev. Therefore, additional national requirements on registrations cannot be excluded. The study started in December 2022 and will be running for 36 months (December 2025). relevant harmonised standards are not sufficient, or. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union Enhancing competitiveness while ensuring the safety and performance of medical devices is a key objective of the European Commission. eu Guidance on classification of medical devicesOctober 2021This document has been endorsed by the Medical Device Coordination Group (MD. COMMISSION IMPLEMENTING DECISION (EU) 2021/1182. EUDAMED is the database of Medical Devices available on the EU Market. The Commission shall be assisted by the Committee set up by Article 6 (2) of Directive 90/385/EEC. The regulation was published on 5 April 2017 Welcome to the EUDAMED information centre. While the IVDR has been applicable since 26 May What is the Medical Devices Regulation about? The EU rules on the safety and performance of medical devices were created in the 1990s. It was established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council. E. It also contributes to a uniform application of the Directives. Annual overview of devices subject to the CECP Study supporting the monitoring of availability of medical devices on the EU market. no harmonised standards exist, or. Jan 6, 2015 · Examples are the use of free nanomaterials being a medical device and administered to the patient as such (e. May 26, 2021 · Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices News announcement 26 May 2021 Directorate-General for Health and Food Safety 1 min read 1 DECEMBER 2021 The proposal was approved by Parliament on 10 April 2024 and is awaiting the Council’s decision. Official Journal of the European Union. Jul 19, 2021 · Text. This allows for progressive roll-out of the new framework. Flags of the European Union fly outside the European Commission’s headquarters in Brussels. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. 26 OCTOBER 2021. Among its various uses, it will be utilised by manufacturers for the registration of medical devices in EUDAMED, This site uses cookies. 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. MDR 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. As regards the transitional regime of Directive 2007/47/EC see the interpretative document of the Commission's services of 5 June 2009 (35 kB) 2. Apr 28, 2021 · 1 DECEMBER 2021. Objectives Jun 2, 2020 · The delivery of health services is a responsibility of each member state in the EU, but Article 168 of the Treaty of Lisbon of 2007 sanctioned joint ‘measures setting high standards of quality and safety for medicinal products and devices for medical use’. Successive amendments to Implementing Decision (EU) 2021/1195 have been incorporated Factsheet European Health Union: Supporting the transition to the new medical device framework Proposal for a Regulation amending Regulation (EU) 2017/745 Medical devices – new Regulations IP/23/23 Quotes: Medical devices save lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring and treatment of diseases. It helps the economic operators in the implementation of the requirements introduced by the new UDI system. For information about the content and availability of European standards, please contact the European Standardisation Organisations . The extended transition periods concern devices that require involvement of a notified body for conformity assessment under Regulation (EU Dec 16, 2022 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Apr 13, 2022 · Notice to Stakeholders: EU-Türkiye Customs Union Agreement in the field of medical devices News announcement 13 April 2022 Directorate-General for Health and Food Safety 1 min read 13 APRIL 2022 Feb 21, 2024 · 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. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards The EU is active in many different areas, such as improving vaccine confidence, ensuring all citizens have access to the medicines and medical devices they need at an affordable price, reducing the burden of cancer, and other leading non-communicable diseases, and reaping the benefits of digitalisation for healthcare and services. These tables consolidate the national translation requirements for medical devices and in vitro diagnostic medical devices, respectively, across 31 European countries. 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). 26 KB - PDF) Download. Regulation (EU) 2017/745 on medical devices(MDR) threaten the continued availability of certain medical devices needed for health systems and patients and may jeopardise the access of inno. The proposal will now be negotiated by the European Parliament and the Council. 2021. Oct 26, 2021 · Intensive preparations continue for the full roll-out of the new medical devices Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR). The EU has revised the legal framework of the current 3 directives to reflect progress over the last 20 years. For further information on EUDAMED, please visit the medical devices section of the European Commission website. Although this is a useful nod to the tensions between ESG and health and The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science and progress in law-making. The EU’s pledge to ensure that only safe and performant medical devices are placed on the EU market and provided to patients involve engaging with international regulators to set high standards and promote regulatory convergence. iron oxide or gold nanomaterials for heat therapy against cancer), free nanomaterials in a paste-like formulation (e. 14 IVD Jun 4, 2021 · of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED). English. MDCG Working Groups The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation… Apr 24, 2024 · China’s procurement market for medical devices has gradually become more closed for European and foreign companies, the European Commission alleges. Jan 6, 2023 · As previously outlined in the EPSCO Council (Health) meeting on 9 December 2022 (Information Note), the European Commission adopted draft legislation on 6 January 2023 amending Regulations (EU) 2017/745 (Medical Devices Regulation – MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation – IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical See all EU institutions and bodies This site uses cookies. Health Ministers called on the Medical Device Coordination Group (MDCG) to propose solutions to address, as a This MEDDEV contains guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC1, as amended. (237. In April 2017, the European Parliament and the Council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory framework for medical devices and in vitro diagnostic medical devices. On 20 June 2014, the Employment, Social Policy, Health and Consumers Affairs Commission Regulation (EU) No 207/2012 (2) has established conditions under which instructions for use of medical devices subject to Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) could be provided in electronic form instead of in paper form. In late 2022, the EU and UK announced proposed delays to the implementation of new medical device regimes in both markets, setting new timelines May 26, 2021 · Public health: Stronger rules on medical devices. A medical device is any product used for medical purposes, including diagnosis, prevention, treatment, investigation or changes to anatomy, as well as contraception devices and sterilising medical equipment. 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. Apr 24, 2024 · The European Commission launched a probe into China's public procurement of medical devices on Wednesday, the latest in a series of moves that ratchet up trade tensions ahead of President Xi Jan 17, 2024 · The Commission and Member States have created MDR and IVDR tables. Participants: Competent authorities, stakeholders. The European Commission issued a new questions and answers (Q&A) document to provide information on the transitional provisions for products without an intended medical purpose covered by Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR), for which common specifications have been set out in Commission Implementing Regulation (EU Guidelines related to medical devices regulations. Prepares a common European view on IMDRF issues and discuss other international issues related to medical devices and in-vitro diagnostic medical devices, in particular it monitors international regulation trends. News. 13 rev. Third country concerned: China. Sean Gallup via Getty Images. …. A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. EN. Horizontal role in the implementation of the medical device and in vitro diagnostic medical device regulations. Brussels Area, Belgium. Active device for diagnosis: International Cooperation. Both Council Directives have been repealed and replaced by Regulation (EU) 2017/745. 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. Webpage on medical devices. Apr 29, 2021 · European Commission. e. of 16 July 2021. g. 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. Nov 21, 2023 · 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 Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. In this Active therapeutical device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap13. 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 May 26, 2021 · Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The MDCG advises and assists the Commission and EU countries in 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 repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. europa. on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council. Implementing Decision (EU) 2024/815 amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical Apr 26, 2020 · 1 DECEMBER 2021. Jun 2019 - Present 5 years 2 months. (321. Published April 24, 2024. md_mdcg_2021_factsheet-cl1_en. EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. 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 . . This issue of the Medical Devices newsletter updates you on the roll-out of the IVDR and points you to guidelines on the classification of medical devices, among other news. An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/746 of The European Commission’s Medical Device Coordination Group (MDCG) has published a Q&A reference document covering clinical investigation requirements under the Medical Devices Regulation (MDR). n 5 April 2017 (1). 171/01)BackgroundThe Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council was adopted. . Jan 23, 2024 · to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro; See the Commission proposal and press release, Q&A and Factsheet. The document is not a European Commission document and it cannot be regarded as European Commission. Relevant documents and links on UDI/Device registration are published below. , class D devices. 27 KB - PDF) Download. 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. (408. It served as a platform for dialogue and sharing of information with Member States’ representatives on the demand and supply of medical equipment at EU level and on means to overcome shortages and build capacity. Mar 26, 2021 · Medical devices Regulation (MDR) Newsletter issue of 26/03/2021. Sep 4, 2020 · 4 September 2020 - updated 3 years ago. The new MDCG document includes 28 questions and answers, providing additional clarity on several issues regarding the MDR’s substantial clinical Sep 1, 2021 · Medical devices and in vitro diagnostic medical devices (IVDs) play a vital role in saving lives by providing solutions for the prevention, diagnosis, monitoring and treatment of disease. 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024 1 min read News announcement Mar 25, 2024 · Overview. 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 ). Factsheet 29 April 2021 1 min read. ative medical devices to the EU market (1). The representative of the Commission shall submit to the Committee a draft of the measures to be taken. md_manufacturers_factsheet_en. The EURLs have two main categories of tasks: advisory ones and those related to conformity assessment, particularly of the highest risk, i. THE EUROPEAN COMMISSION, Mar 28, 2023 · Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods News announcement 28 March 2023 Directorate-General for Health and Food Safety 1 min read Jan 9, 2023 · Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. This guidance aims to ensure a consistent interpretation of the criteria to be applied when deciding Mar 7, 2023 · At the EPSCO Council on 9 December 2022, EU Health Ministers called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Devices Regulation. Email. 50–52). International matters – Terms of reference. G) established by Article 103 of Regulation (EU) 2017/745. 4 A small unit in the European Commission (EC) is responsible for legal policy and co on electronic instructions for use of medical devices (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to 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 (1), and in Publications in the Official Journal. Chairing the MDCG New Technologies, Nomenclature and International Matters working groups. 7. 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 Jan 11, 2023 · The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR Apr 10, 2024 · The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - commissioned a “Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market”. pdf. md_mdcg_2021_mdsw_en. We're pleased to inform you about the in-depth analysis we have conducted at COCIR with regard to Artificial Intelligence in EU Medical Device Legislation. The central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation – including a detailed FAQ section and a library of all platform user guides. Analysing all aspects of the conformity assessment process and how they would apply to AI-based medical devices with different characteristics, this The European Commission has adopted several implementing measures based on the medical devices directives. It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis. L 256/100. Mar 23, 2021 · Infographic - Is your software a Medical Device? 1 DECEMBER 2021. nanosilver as antibacterial agent May 26, 2021 · The Commission set up a ‘clearing house for medical equipment (COVID-19)’ to identify available supplies and facilitate the matching with demand in EU countries. Visit our cookies policy page or click the link in any footer for more information and to change your preferences. 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. Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices. Initiation: 24/04/2024. The new regulations create a robust, transparent, and sustainable regulatory framework, recognised Feb 8, 2024 · On 17th January 2024, the European Commission released two tables summarising the language requirements for manufacturers of medical devices under the EU MDR and IVDR. European Commission contact point: Directorate-General for Health and Food Safety. The new rules start applying after a one-year postponement due to the unprecedented challenges of the coronavirus Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745. 19. pi xb ay il iq kf dz bq kt qr