EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products

2020 ◽  
Vol 9 (8) ◽  
pp. 320-324
Author(s):  
Kate Kelso
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Dermal Filler ◽  
The World ◽  
The Uk ◽  
The Eu ◽  
Medical Device Regulation

Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) ( EU 2017 /745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

scholarly journals US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

2012 ◽  
Vol 8 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Jona A. Hattangadi ◽  
James T. O'Reilly ◽  
Abram Recht
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Radiation Oncology ◽  
Food And Drug Administration ◽  
Regulatory Framework ◽  
General Review ◽  
Medical Device Regulation

A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

An analysis of food and drug administration medical device reports relating to total joint components

1997 ◽  
Vol 12 (7) ◽  
pp. 765-771 ◽  
Author(s):  
Frank P. Castro ◽  
George Chimento ◽  
Barry G. Munn ◽  
Richard S. Levy ◽  
Stephen Timon ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Administration Medical

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

scholarly journals Revising Emission Responsibilities through Consumption-Based Accounting: A European and Post-Brexit Perspective

2019 ◽  
Vol 11 (2) ◽  
pp. 488 ◽  
Author(s):  
Paola Fezzigna ◽  
Simone Borghesi ◽  
Dario Caro
Keyword(s):  
International Trade ◽  
Co2 Emissions ◽  
Trade Flows ◽  
Environmental Implications ◽  
Traded Goods ◽  
The World ◽  
Trading Partners ◽  
The Uk ◽  
The Impact ◽  
The Eu

International trade shifts production of a large amount of carbon dioxide (CO2) emissions embodied in traded goods from the importing country to the exporting country. The European Union (EU) plays a prominent role in the flow of international-related emissions as it accounts for the second largest share of global exports and imports of goods. Consumption-based accountings (CBA) emerged as alternative to the traditional emission inventories based on the Intergovernmental Panel on Climate Change (IPCC) guidelines. According to the IPCC criteria, countries where products are consumed take no responsibility for the emissions produced by exporter countries, thus neglecting the emissions embodied in trade. By taking this aspect into account, CBA are considered of great importance in revealing emissions attributed to the final consumer. Using a CBA approach, this paper evaluates the impact of international trade in the EU in terms of CO2 emissions, looking both at the internal trade flows within the EU-28 and at the external trade flows between the EU and the rest of the world during the period 2012–2015. We find that the EU is a net importer of emissions as its emissions due to consumption exceed those due to production. In particular, in 2015 the ratio between import- and export-embodied emissions was more than 3:1 for the EU-28 that imported 1317 Mt CO2 from the rest of the world (mainly from China and Russia) while exporting only 424 Mt CO2. Concerning emissions flows among EU countries, Germany represents the largest importer, followed by the UK. To get a deeper understanding on possible environmental implications of Brexit on UK emission responsibilities, the paper also advances a few hypotheses on how trade flows could change based on the existing trade patterns of the UK. Data analysis shows that a 10% shift of UK imports from EU partners to its main non-EU trading partners (India, China, and US) would increase its emission responsibility by 5%. The increase in UK emission responsibility would more than double (+11%) in case of a 30% shift of UK imports. Similar results would apply if UK replaced its current EU partners with its main Commonwealth trading partners as a result of Brexit.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), “intended” clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients’ well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer’s understanding of their device’s clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits.

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