Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repealed Directive...
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Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical...
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Medical Devices Directive (category Regulation of medical devices)
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)...
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Real world data (section EU context)
Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)" from December 2022. 21st Century Cures Act (US) Correlation...
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a contact point with the EU member states competent authorities. Medical Device Regulation ("MDR") — Regulation (EU) 2017/745 — and in vitro diagnostic...
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Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union Medical Device Regulation Act of 1976 in the United States This...
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protection of their own personal data [1]. The regulation enetered into force on 25 May 2018. Regulation (EU) 2017/745 on the clinical investigation and sale...
23 KB (2,871 words) - 11:53, 31 August 2024
Postmarketing surveillance (category Regulation of medical devices)
of the member state the company resides in. The Medical Device Regulation (EU) 2017/745 (MDR) provides in §2 the following definition of post-market surveillance:...
7 KB (764 words) - 14:44, 5 November 2024
Custom-made medical device (category Regulation of medical devices)
manufactured in the European Union are subject to Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]), which replaced and repealed Directive 93/42/EEC...
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medical devices under the European Union's Medical Device Regulation (Regulation (EU) 2017/745, EU-MRR).[2][3] The company operates a quality management system...
10 KB (1,077 words) - 02:27, 28 October 2024
"Regulation (Eu) 2017/745 of the European Parliament and of the Council on medical devices". Official Journal of the European Union. 5 April 2017. Biswas...
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ISO 14971 (category Regulation of medical devices)
diagnostic medical devices REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT...
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Substance-based medical device (category Regulation of medical devices)
encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according...
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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)...
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digital therapeutics in practice. In the European Union, regulation (EU) 2017/745, commonly known as "EU MDR" classifies potential digital therapeutics in terms...
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Requirements and tests Regulation (EU) 2017/745 of the European Parliament and of the council, (2017) https://eurlex.europa.eu/legal-content/EN/TXT/PDF/...
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Total disc replacement (section Regulation)
approval process for medical devices. In Europe, Regulation (EU) 2017/745 defined the Medical Device Regulation (MDR) used for reviewing, approving, and monitoring...
19 KB (1,928 words) - 20:35, 9 August 2024
Hotchkiss, J. (23 August 2017). "UK Flirt (Class 745 & Class 755) – Project at an Advanced Stage of Development – TSI CCS 2016/919/EU" (PDF). Letter to T....
15 KB (1,022 words) - 14:37, 27 August 2024
Notified body (category Regulation in the European Union)
conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general...
15 KB (1,589 words) - 14:32, 1 March 2024
Watson and Belmann [1976] ECR 1185 Case C-292/89 Antonissen [1991] ECR I-745 Regulation (EEC) No 1612/68 of the Council of 15 October 1968 on freedom of movement...
68 KB (2,772 words) - 10:46, 5 October 2024
Diacetyl (section Regulation)
and Environmental Microbiology. 65 (2): 740–745. Bibcode:1999ApEnM..65..740N. doi:10.1128/AEM.65.2.740-745.1999. PMC 91089. PMID 9925610. Martineau B,...
19 KB (1,634 words) - 11:19, 8 November 2024
Single use medical device reprocessing (section International Regulation of "Single-Use" Medical Device Reprocessing)
removals, the quality system regulation ("QSR"); and labeling requirements. According to Article 17 of the Regulation (EU) 2017/745 (MDR) on medical devices...
39 KB (4,530 words) - 05:05, 5 April 2024
Medical device (redirect from Regulation of medical devices)
Medical Devices Regulation (MDR (EU) 2017/745) The In Vitro Diagnostic medical devices regulation (IVDR (EU) 2017/746) The two regulations are supplemented...
77 KB (8,695 words) - 12:40, 31 October 2024
The Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (European Medical Device Regulation-MDR)...
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Unique Device Identification (category Regulation of medical devices)
Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746" (PDF). Health.ec.europa.eu. Retrieved July 23, 2022. What about...
9 KB (1,112 words) - 18:46, 29 March 2023
Design controls (category Regulation of medical devices)
regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow...
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Romania (section NATO and EU integration)
the stock of a local economy) amounted to $745 million in December 2018, the lowest value among the 28 EU member states. Some companies that have invested...
256 KB (21,782 words) - 01:54, 12 November 2024
List of European Court of Justice rulings (redirect from List of eu cases)
of investments was "not compatible with EU law". Allianz SpA v West Tankers, case C-185/07, concerned Regulation 44/2001 on the recognition and enforcement...
82 KB (10,856 words) - 04:09, 13 October 2024
Georgia (country) (category Articles with dead external links from July 2017)
2016, EU and Georgia reached the agreement on visa liberalization for Georgian citizens. On 27 February 2017, the Council adopted a regulation on visa...
231 KB (21,755 words) - 05:50, 11 November 2024
This is a list of statutory instruments made in the United Kingdom in 2017. Law portal United Kingdom portal List of statutory instruments of the United...
213 KB (55 words) - 02:39, 14 September 2024