Eu mdr latest updates

Eu mdr latest updates. MDR Regulation 26 MAY 2017 MDR enters into force 26 MAY 2017 IVDR enters into force 26 MAY 2020 fully applies 26 MAY 2022 IVDR fully applies From 26 MAY 2017 Devices that conform with the Medical Devices Regulation (MDR) may be placed on the market MDD/AIMDD Directives Until 25 May 2020All certificates issued under the Medical Jan 31, 2023 · A short, but positive update to the proposal to extend the MDR transition period. MDCG 2022-16 –Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) October 2022 Download. 1 min read. European Commissioners have published a new Q&A resource document covering recent amendments to European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements. Below are sample questions from the guidance document, and summarized . Given the logistical and financial hurdles that manufacturers will have to overcome to achieve compliance, devices that already carry a valid MDD certificate have a bit of a grace period. May 26, 2020 · Regulation (EU) 2017/745 on medical devices (MDR) introduces a major update of the regulatory framework in the European Union (EU). It introduces more stringent requirements for clinical evidence, transparency, and traceability, which sets a new standard for the safety and effectiveness of medical gadgets available in the European market. Additionally, the new EU MDR introduces a new requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR). Aug 21, 2024 · Up-to-the-minute news and updates from the European MDR & IVDR compliance experts. The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU… Mar 20, 2023 · March 20 2023: On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect. This type of report is quite well known in the pharmaceutical world but it is considered a new requirement in the medical device sector. Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. Information session on MDR/IVDR for international regulators – 4 July 2024. Sponsors also have the option to use the EU MDR Transition web publication service to provide market notifications to health care providers and consumers for devices going through low-risk changes as part of the EU MDR transition. Of note are the revised timetables featured in this FAQ. July 2024: Update of MDCG 2020-16 Rev. . The MDR replaces the previous EU Medical Device Directive (MDD), and is designed to modernize the EU regulatory system to better address the current needs of the market and new technologies. This includes additional standards harmonized with the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR) and published in the Official Journal of European Union (OJEU). Archive The pages listed below remain accessible but following the date of application they are no longer being updated. 1 - Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) - December 2023 Apr 25, 2024 · EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff & New MDR/IVDR Industry Survey April 26, 2024. If your time is short: Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization. Nov 29, 2023 · Update - MDCG 2022-11 - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023 Oct 12, 2023 · Implementation OF EU MDR extension: The MDR, which came into effect in 2017, has a transition period ending on 31 December 2027 or 31 December 2028, as applicable, Manufacturers must ensure compliance with the new requirements, including stricter classification rules, enhanced post-market surveillance, and increased transparency. Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to Mar 28, 2022 · MDCG's update comes against a backdrop of continued debate about the implementation of MDR. Jul 10, 2024 · On 9 July 2024, regulation (EU) 2024/1860 was published regarding a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply of devices and transitional provisions for certain in vitro diagnostic medical devices. The Complete Guide To EU-MDR Transition The D Group. In a proposal to the European Jan 9, 2024 · On 15 March 2023, the European Union extended the EU MDR transition periods. EU Health Commissioner Stella Kyriakides seeks to pair the delay with “additional measures to address the structural problems” of MDR, including the need for targeted solutions EU legislation on medical devices Regulation (EU) 2017/745 on medical devices (MDR) adopted in April 2017 and entered into force in May 2017, as amended –fully applicable from 26 May 2021 Directive 90/385/EEC on active implantable medical devices (AIMDD) Directive 93/42/EEC on medical devices (MDD) Directive 98/79/EC on in vitro Mar 24, 2022 · Latest updates Update - MDCG 2019-9 - Rev. As you know, earlier this month the EU Commission issued a proposal to push the MDR transition deadline out until: 31 December 2027- Class IIb implantable and Class III devices By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. Analytical cookies help us improve our website by providing insight on how visitors interact with our site, and necessary cookies which the website needs to function properly. They include a best practice guide to the (re-)designation and notification process and the addition forms to be submitted by an applicant Notified Body. Mar 28, 2023 · The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). Update of MDCG 2021-5 Rev. Jul 3, 2024 · 1. This extension is for devices transitioning to the EU MDR from 26 May 2024 to: 26 May 2026 for class III implantable custom-made devices / Vigilance compared to the MDD Update links to additional guidance on MEDDEV 2. Jul 29, 2024 · One thing to bear in mind is that EU MDR is a very new update on the medical device landscape and is widely touted to be a predictor of where medical device regulations are headed as a whole. It contains a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). Aug 31, 2022 · This article, authored by Kolabtree’s freelance scientist Aditi Kandlur, elaborates on the MDR updates you need to keep an eye on as we traverse 2022. Transfer of appropriate surveillance from your Directive Notified Body to the MDR Notified Body. For medical device companies, if you want to enter both the US and EU markets, then you need to be very aware of the similarities and differences between Feb 16, 2023 · This means more time will only be granted for products that are safe and for which manufacturers have already taken steps to convert to MDR: The application must be submitted by 26 May 2024 at the latest and the contractual agreement with the Notified Bodies must be concluded by 26 September 2024 at the latest. The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices By Annette Van Raamsdonk. ec. May 14, 2024 · The extended EU MDR transition deadline is just around the corner for manufacturers looking to sell their medical devices in the European Economic Area (EAA). Mar 27, 2023 · By Annette Van Raamsdonk and Evangeline Loh. June 2024: Dec 6, 2023 · Latest updates. Dec 16, 2022 · Latest updates MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022 News announcement 16 December 2022 Directorate-General for Health and Food Safety 1 min read Dec 19, 2023 · Update - MDCG 2019-7 - Rev. 1 Guidance on standardisation for medical devices. Implementation of the future regulations. or you may even think that it is a requirement of the EU MDR regulation. The new regulations are aimed at ensuring patient safety and protecting public health, as well as avoiding disruption of the medical Aug 18, 2022 · Implemented in 2021 for new products, the European Union Medical Device Regulations (EU MDR) updated the requirements for medical devices seeking permission to sell in European markets. 2022-7 – Q&A on the UDI system under the MDR/IVDR. A UDI system is mandatory under the MDR/IVDR and voluntary under the old Directives. Mar 11, 2024 · On 8 March 2024, Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for single-use medical gloves, biological evaluation of medical devices, sterilization of healthcare products, packaging for medical devices to be sterilized in the final packaging and reprocessing of healthcare products was published in The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively New Regulations The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. Responsible persons, authorized representatives and the new EU Regulations: BSI: MDR IVDR Guidance: Planning for implementation of the European Union Medical Devices Regulations – Are you prepared? BSI: The proposed EU regulations for medical and in vitro diagnostic devices – An overview of the likely outcomes and the consequences for the Jun 17, 2022 · ⚠️ Update: See below for important updates on EU-MDR compliance. Dec 9, 2022 · The EU Council confirmed they will present a legislative amendment in early 2023 to postpone the May 2024 MDR deadline, and more. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Feb 20, 2023 · The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The European Commission (EC) updated several medical device safety regulation documents in March 2024. Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Reg EU 2024/1860. What is European Union (EU) Medical Device Regulation (MDR) Published in the Official Journal of the European Union in April 2017, the European Union’s (EU) Medical Device Regulation (Regulation (EU) 2017/745) was developed to reflect the significant progress in medical device technologies that had taken place since the implementation of the EU’s initial framework in the 1990s, and to Jul 2, 2024 · Latest updates Update - MDCG 2021-5 Rev. g. Earlier this month, medtech trade groups in France and Germany, whose members make up more than half of the EU market, called for an extension of the MDR transition period to avoid a "collapse in patient care. Oct 17, 2023 · 2. Dec 8, 2022 · The EU Health Commissioner will on Friday propose extending the deadline for companies to comply with a new law regulating medical devices, she told Reuters on Thursday as doctors warn the Dec 20, 2022 · At the recent EPSCO meeting on December 9, 2022, The European Commission proposed new transition period extensions for the EU MDR. Effective May 26, 2024, companies must submit a conformity assessment application and implement a quality management system (QMS) according to the latest EU MDR guidelines to obtain their product certification. Aug 23, 2023 · Latest updates Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period News announcement 23 August 2023 Directorate-General for Health and Food Safety 1 min read Mar 28, 2023 · Home; Latest updates; 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 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 minimum requirements for clinical evaluations are described in Annex XIV, part A, of the MDR and further guidance is provided in MEDDEV 2. The proposal recognises the challenges in capacity across notified bodies. Keeping up with timely EU MDR updates is crucial for medical device companies, enabling them to ensure adherence to the set of regulations that govern the marketing and sale of medical device products in the European Economic area. The vote also supported nixing the sell-off date provision for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR). MDCG UPDATE MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 October 2022 Apr 8, 2022 · The EU regulation 2017/745 on medical devices, or EU MDR, was a major update to medical device regulations introduced in 2017. Mar 19, 2024 · You need to think about how to establish robust processes that can adapt to evolving regulatory requirements, as well as to ensure procedures, trained resources, and systems are in place to efficiently incorporate updates/modification from the latest regulations. europa. The EU Council agreed on its mandate on 14 February 2024. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. " The trade groups called for a two-year One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). The new arrangements recognise the challenges in Jan 23, 2020 · 11 Key Changes to the EU Medical Device Regulation (update summary) Unique Device Identification (UDI) System (Article 27, Annex VI) A UDI device identifier (UDI-DI) and a UDI production identifier (UDI-PI) will be required on all products to be placed on the EU market, with the exception of custom-made devices and investigational devices. The implementation of the EU Medical Device Regulation is a significant moment for the entire industry. The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of Medical Device Directives by several medical device 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. eu May 26, 2021 · 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. How is the new EU MDR structured? The new MDR document is 174 pages in length. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data May 27, 2024 · Latest updates Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance News announcement 27 May 2024 Directorate-General for Health and Food Safety 1 min read Dec 31, 2020 · We are reviewing our position on acceptance of EU MDR and EU IVDR CE certificates renewed after a strengthened future regime for medical devices is in place, taking on board stakeholder feedback Feb 27, 2024 · Conclusion. Dec 21, 2023 · Latest updates MDCG 2023-7 - Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR - December 2023 News announcement 21 December 2023 Directorate-General for Health and Food Safety 1 min read Nov 2, 2023 · Writing Your EU MDR Clinical Evaluation Report and When to Update It. Key MDR and IVDR amendments under consideration 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. In addition to incorporating the postponement of MDR implementation until 2021, the updated document also reflects the implementation delay of EUDAMED, the EU medical devices database, which was announced in October 2019. Oct 5, 2023 · The latest revised and new documents from the EC and MDCG cover Medical Devices Regulation (MDR) transitional provisions for devices falling under Ann3ex XVI, and the Manual on Borderline and Classification for Medical Devices. , devices with MDD/AIMDD certificates that expired prior to 20 March 2023, but are now considered valid due to EU Regulation 2023/607. This modernisation of the European regulatory system brings about several changes to the information provided with the devices and their regulatory documentation. Dec 9, 2022 · MDCG 2022-18 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - December 2022 By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. The proposal would also repeal the @sell-off@ date provision under both MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Jun 24, 2022 · On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. Which devices covered by expired MDD/AIMDD certificates can benefit from longer timelines. MDD was applicable to all medical devices sold within the European market, and it listed specific requirements meant to standardize medical device technical qualifications, basic testing procedures, and regulatory and certification guidelines. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. Documentation. 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. You’ve done a lot of work to get this far. 12/1 rev. Apr 4, 2024 · By Megan Gottlieb and Evangeline Loh. 26 July 2024. Apr 18, 2023 · The above-linked MHRA announcement states it will also recognize devices covered under the EU MDR extension, e. After its first year in existence, the medtech community’s initial concerns with the MDR’s requirements have now become a matter of increasing frustration for many, including those of us who are dedicated to advancing the clinical adoption of focused ultrasound. Jun 26, 2022 · The EU Medical Devices Regulation (2017/745) (EU MDR) therefore took effect in Northern Ireland on 26 May 2021 and the in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) took Feb 17, 2023 · The amendment will enter into force on the date of its publication in the Official Journal of the European Union (OJEU), but first the amendment must be adopted by the European Council (expected by the end of February). News announcement. Producers of medical devices will now have until December 31, 2027, for higher risk devices and until December 31, 2028, for medium and lower risk devices Jun 18, 2024 · We have developed an Online assessment tool and notification form to assist with the transition. The Notified Body Operations Group (NBOG) published several new documents related to the EU MDR and EU IVDR on their website. 1 (MDR 2017/745). If you prefer the HTML with TOC version just look into the HMTL column ans select the version for your native language. The EU Council endorsed the compromise agreement reached with the European Parliament on 21 February 2024. Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by May 26, 2024, a quality management system and an agreement with said notified body by September 26, 2024. The objective of the amending Regulation is to address the projected imminent risks of shortages of medical devices in EU due to the slower than anticipated transition May 30, 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. Apr 6, 2023 · Recent Update. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device. If it's happening, it's here. The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). 7 rev 4. Dec 2022: EU Council to Postpone MDR Deadline - Casus Consulting Dec 12, 2022 · The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages. Abolishment of the sell-off provisions in the MDR and its impact. Below is a listing of each of these mandatory pieces of information Jan 31, 2024 · We briefly share again the requirements for Regulation 2023/607 amending the European Medical Devices Regulation (2017/745, MDR). March in Europe . For implantable devices and class III devices, other than custom-made or investigational devices, the manufacturer must update the post-market clinical follow-up evaluation report as it will serve an input for the writing of the Periodic Safety Update Report, and, if indicated, the summary of safety and clinical performance6 (MDR Article 32). See full list on health. Manufacturers must secure an application with a Notified Body to review the legacy device (or a substitute device) to the MDR. It is true that the EU MDR has some necessary documentation to be able to distribute medical devices in the European Union, so it is helpful to know exactly what the regulation requires before you start. EU MDR and supporting guidance give strict timelines for the Download from the link below the MDR in the main European languages. Dec 13, 2022 · This website uses cookies. com 3 INTRODUCTION The release of the new Medical Devices Regulation (EU-MDR) in the Official Journal of the European Union in May of 2017 marked the start of a three-year transition period for manufacturers, suppliers, Notified Bodies, and national Competent Authorities to comply with the new Jul 25, 2017 · MDR Article 86 Periodic safety update report reads: 1. Dec 8, 2022 · During a December 2022 meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the Commission committed to establish actions to be taken to address the foreseeable shortage of medical devices in the EU caused by the challenges related to the implementation of the MDR. 1 - Summary of safety and clinical performance News announcement 24 March 2022 Directorate-General for Health and Food Safety 1 min read Jun 10, 2022 · The Medical Device Coordination Group (MDCG) released a new guidance document on European Unique Device Identifier (UDI) requirements. 9 July 2024. Software and mobile applications that fall under the definition of a medical device or an in-vitro diagnostic medical device are regulated by the respective Directives 93/42/EEC or 98/79/EC. The European Union Medical Devices Directive (MDD) was established in 1994 to regulate medical devices sold within the EU. Writing a medical device clinical evaluation report (CER) is the culmination of a monumental effort to conduct literature searches, find/review literature, and/or conduct original clinical investigations. Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR Mar 22, 2023 · An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20. Compared with the MDD, which was 60 pages in length, the new regulations are much longer and more detailed. The proposal will now be negotiated by the European Parliament and the Council. The first deadline is swiftly approaching, May 26, 2024. Sep 19, 2021 · The new consultation solicits feedback from stakeholders on planned changes to the UK’s Medical Devices Regulations 2002 as part of a broader transition away from European Union legal and regulatory systems; beginning in July 2023, the MHRA will no longer accept EU CE Marking for medical devices, and will instead require manufacturers to So, what is actually new in the EU MDR? - Post Market Surveillance (PMS); Notified Bodies will play a bigger role in supervising the manufacturer’s PMS system. EU MDR transitional period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented on March 20th, 2023. Manufacturers marketing medical devices in the EU will want to take note of updated frequently asked questions (FAQs) regarding the clinical investigations section of the Medical Device Coordination Group (MDCG) document MDCG 2021-6 Rev. Here is the direct link to MDR English version HTML with TOC Regulation (EU) 2017/745 of the European Parliament and of […] Aug 29, 2017 · The EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR) have applied in EU Member States and in Northern Ireland since 26 May 2021 Apr 15, 2024 · Regulation 2023/607 amended the EU Medical Devices Regulation (2017/745, MDR) to grant more time for legacy medical devices to become compliant with the MDR. Sep 26, 2023 · Latest updates Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR News announcement 26 September 2023 Directorate-General for Health and Food Safety 1 min read Feb 16, 2023 · The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the economic region. The new transition timelines, which devices benefit from them and under what conditions. Apr 21, 2024 · Clinical evaluations are mandatory for all medical devices marketed in Europe under the EU Medical Device Regulation (MDR, 2017/745). May 12, 2023 · UPDATE - MDCG 2020-3 Rev. Find out more here. Jan 9, 2023 · One month ago, European Union Health Commissioner Stella Kyriakides proposed delaying MDR enforcement by three to four years to prevent product shortages and buy time to implement “additional measures to address the structural problems” with the regulation. Table of Contents. Jan 23, 2024 · In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. 8 July 2019 and Manufacturers incident report (MIR) as from January 2020. EU health ministers met to address the pressures currently on the MedTech industry including notified body bottlenecks with conformity assessments under the EU MDR/IVDR. Listed below are some of the most recent publications supporting the implementation of the EU MDR. This All medical devices that carry a CE mark will be required to meet the new EU MDR guidelines, and no devices will be grandfathered in. Dec 9, 2022 · The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. Mar 20, 2023 · (2) Due to the impact of the COVID-19 pandemic, the date of application of Regulation (EU) 2017/745 was postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council (8), while 26 May 2024 was maintained as the end date of the transitional period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC Medical Devices - Topics of Interest. Both regulations entered into force on May 26, 2017; new rules will apply starting May 26, 2020, for MDR, and May 26, 2022, for IVDR. As manufacturers transition to the new EU MDR requirements, it’s important for regulatory departments to understand the implications of related changes on Aug 19, 2020 · Revised timelines reflect MDR and EUDAMED implementation delays. 1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023 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. Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746, has been published. Mar 13, 2024 · Latest updates Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 October 2023) - Revised version 11 March 2024 News announcement 13 March 2024 Directorate-General for Health and Food Safety 1 min read The European Commission on Friday adopted a proposal to allow medical device makers more time to certify their products under the EU Medical Devices Regulation (MDR) amid concerns that the regulation could prompt shortages of lifesaving products. Page edited 26 April 2024. 1 - Guidance on standardisation for medical devices - July 2024 News announcement 2 July 2024 Directorate-General for Health and Food Safety 1 min read So, what is actually new in the EU MDR? - Post Market Surveillance (PMS); Notified Bodies will play a bigger role in supervising the manufacturer’s PMS system. The Commission has now formalized Kyriakides’ plan. iogfxd muaeln qwh zfym hiuioi mfzji ufpdtah upixyqaz rzquo mhxjc