https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
EN. Official Journal of the European Union. L 117/1. 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.

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 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.

https://www.dnv.com/services/medical-devices-regulation-eu-2017-745-mdr-138310
The Medical Devices Regulation (MDR) date of application is 26 May 2021 meaning compliance is mandatory to be able to place Medical Devices on the European market from this date, unless the transition arrangements allows the continued placing of devices on the market. In vitro Diagnostic Medical Devices Regulation (IVDR) applies from 26 May 2022.

https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
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.. The Medical Devices Regulation applies since 26 May 2021.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
of 5 Apr il 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and ... predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst suppor ting innovation. (2) This Regulation aims to ensure the smooth functioning of the internal market as regards

https://en.wikipedia.org/wiki/Regulation_(EU)_2017/745
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. 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.. The regulation was published on 5 April 2017 and came into force on 25 May 2017.

https://health.ec.europa.eu/medical-devices-new-regulations/getting-ready-new-regulations_en
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 new regulations create a robust, transparent, and sustainable regulatory framework, recognised

https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX%3A32017R0745
MAIN DOCUMENT 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 (OJ L 117, 5.5.2017, pp. 1-175). Successive amendments to Regulation (EU) 2017/745 have been incorporated into the original

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
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. While the IVDR has been applicable since 26 May

https://www.intertek.com/assurance/mdr/
The Medical Device Regulation (MDR) was published in the European Union (EU) Official Journal in April 2017 and entered into force on May 26 th, 2021, with a transition period of 3 years before it became mandatory (May 26 th, 2024).Since then, the transitional period for certain MDD (Medical Device Directive) products has been extended according to the amendment to Regulation (EU) 2017/745:

https://www.hse.ie/eng/services/publications/pp/medical-device-regulations.html
The Medical Devices Regulation (EU) 2017/745 is known as the MDR, and the In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 is known as the IVDR. The MDR became fully applicable on 26 May 2021 and the IVDR will have a staggered application from May 2022.

https://www.emergobyul.com/resources/understanding-europes-new-medical-device-regulation-mdr-2017745
Europe's Medical Device Regulation (MDR) has brought substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. In this white paper, Emergo's experts in European regulations discuss the MDR 2017/745 and how it will impact medical

https://eumdr.com/
March 2023: Publication of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Publication of a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

https://www.gov.ie/en/publication/da0cd-medical-device-regulations-eu-2017745-and-in-vitro-diagnostic-medical-devices-regulations-eu-2017746/
These two new Regulations, namely, Regulation (EU) 2017/745 relating to medical devices (MDR) and Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices (IVDR), entered into force following publication in the Official Journal of the European Union in April 2017.

https://eu.bd.com/iv-news/news-innovation/the-european-union-medical-device-regulation-mdr-2017-745/
The European Union Medical Device Regulation (MDR) 2017/745. The European Union (EU) adopted the MDR almost 10 years after it launched a formal review of the European Regulatory framework. The MDR came into force on 26 May 2017 and became applicable on 26 May 2021 in all EU member states. This new regulation has replaced the earlier Medical

https://planetinnovation.com/perspectives/the-eu-medical-device-regulations-eu-2017-745-in-a-nutshell/
The regulations governing medical devices in Europe are changing - in a big way. From May 2020, manufacturers will need to ensure that all* devices meet the new European Medical Device Regulations (MDR)1. Two years later, new In Vitro Diagnostic Device Regulations (IVDR) will also come into force. The new regulations are a huge leap forward

https://medicaldevicehq.com/articles/new-in-the-2017-745-mdr/
The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as "… necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific

https://www.tuv.com/world/en/eu-medical-device-regulation-mdr-2017-745.html
A head start on compliance with the new EU Medical Device Regulation. Manufacturers of medical devices are facing new requirements with MDR 2017/745, which took effect May 25, 2017. The measure gives medical device manufacturers the opportunity to fully focus all possible resources on the fight against the COVID-19 pandemic.

https://www.thema-med.com/en/2020/06/17/mdr-2017-745-medical-devices-regulation-the-major-changes/
The new MDR 2017/745 Medical Devices Regulation contains many novelties and at the same time inconsistencies and gaps which make its implementation particularly complex. Firstly, the requirements content in the MDR are more than those content in the MDD and they concern both the product and the quality system.

https://www.legislation.gov.uk/eur/2017/745/contents
Regulation (EU) 2017/745 of the European Parliament and of the Council Show full title. 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) (revoked)

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20200424
intended medical purpose and those applicable to devices without an intended medical purpose. 4. For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as 'devices'. B

https://www.medical-device-regulation.eu/download-mdr/
Here is the direct link to MDR English version HTML with TOC. 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.

https://ec.europa.eu/newsroom/sante/items/836838/
Today's guidance provides criteria for determining when a medical device or an accessory for a medical device should be regarded as 'orphan device' under the Medical Devices Regulation 2017/745 (MDR). It aims to guide manufacturers and notified bodies when applying the MDR's clinical evidence requirements and help overcome some of the

https://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/medical-device-regulation-2017-745/
The major changes due to MDR 2017 745: i) The Essential Requirements (ER's) are now defined in greater detail, including the expectations placed on Technical Documentation. The ER's are now detailed as the "General Safety and Performance Requirements". In total there are 3 Chapters, split into 23 Sections which explain the new

https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
- MDR Medical Devices Regulation, referring to Regulation (EU) 2017/745 - MDD Medical Devices Directive, referring to Directive 93/42/EE - Non-clinical data Any relevant data that does not meet the MDR definition of clinical data - Non-orphan Refers to a device, indication, or (sub)population which does not

https://www.lexology.com/library/detail.aspx?g=08079c07-748e-41c4-a79e-6de31f371389
These rules are set out in the Executive Order no. 715 of 24 May 2022 on Advertising etc. of Medical Devices ultimately reflecting the EU Regulations 2017/745 and 2017/746 of the European

https://www.asphalion.com/news/regulatory-update-mdcg-2024-10-on-clinical-evaluation-of-orphan-medical-devices/
The Medical Device Regulation (UE) 2017/745 (MDR) has raised the bar for clinical evidence, creating unique challenges for ODs. This new guidance is a beacon for manufacturers navigating the complex pre-market clinical investigations to ensure safety and performance. Key Highlights of MDCG 2024-10:

https://www.nsf.org/in/en/knowledge-library/post-market-surveillance-what-you-need-to-know-to-ensure-patient-safety
21 CFR Part 806, Medical Device Corrections and Removals contains reporting requirements and maintenance of records for corrections and removals. 21 CFR 820.198 Complaint Files; European Union: MDR Requirements. In the European Union, post-market monitoring for medical devices is governed by the Medical Device Regulation (MDR), released in 2017

https://www.biospace.com/article/releases/ikerian-parent-company-of-retinai-u-s-inc-receives-eu-mdr-certificate-for-four-devices-its-ophthalmology-data-platform-and-ai-models/
RetinAI Discovery ® and the AI modules for biomarkers, fluid and layer segmentation, and quantification in retinal pathologies are CE-Marked medical devices according to the Medical Devices Regulation (EU) 2017/745. Discovery is a medical device cleared for clinical use by the FDA. The AI modules for biomarkers, fluid and layer segmentation

https://www.dqsglobal.com/en-za/learn/blog/using-mdsap-to-manage-many-regulatory-systems-for-medical-devices
The implementation of the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), marked a turning point in medical device regulation within the European Union in 2017.Despite the good intentions to increase the safety and effectiveness of medical devices, one might easily conclude that the MDR primarily presents a regulatory jungle with high costs and little benefit for manufacturers.