scholarly journals Medical device legislation for custom-made devices after the UK has left the EU: answers to ten important questions

BDJ ◽  
2021 ◽  
Vol 231 (8) ◽  
pp. 513-521
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Custom Made ◽  
The Uk ◽  
The Eu

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.

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.

The Prospects: The UK Trade Regime with the EU and the World

2017 ◽  
Author(s):  
Giorgio Sacerdoti
Keyword(s):  
Free Trade ◽  
Free Trade Agreement ◽  
Trade Agreement ◽  
Customs Union ◽  
Custom Made ◽  
The World ◽  
Global Agreement ◽  
The Uk ◽  
Default Rules ◽  
The Eu

The chapter provides a thorough examination of the options available to the UK to trade with the EU and the rest of the world. Sacerdoti departs from the understanding that the UK will not remain part of the EU single market or the EU customs union—as clearly indicated by UK Prime Minister May. Sacerdoti considers what could be the features of the new ambitious free trade agreement between the UK and the EU, and explains what would instead be the default rules of the World Trade Organization (WTO), The international trade conditions set by WTO rules are significantly worse than those currently enjoyed by the UK as a member of the EU. Sacerdoti, instead, sees no problem in the UK inheriting the WTO schedule of the EU, and even suggests that the pre-WTO Global Agreement on Trade and Tariffs (GATT) may provide a custom-made solution to keep border-free trade between Northern Ireland and Ireland under the so-called ‘frontier traffic exception’.

Brexit and the EU Area of Freedom, Security, and Justice

2017 ◽  
Author(s):  
Deirdre Curtin
Keyword(s):  
Member State ◽  
Data Retention ◽  
Free Zone ◽  
The Uk ◽  
The Eu

UK involvement in the EU Area of Freedom, Security, and Justice (AFSJ) has been patchy. It never joined the Schengen border-free zone, and when in 2014 it exercised a block exit from all AFSJ measures, it selectively rejoined a substantial number. Even if partially outside, the UK has been a leader inside. Advanced intelligence capabilities meant it provided important support to the functioning of agencies such as Europol and UK laws inspired EU laws, for example, on data retention. The need to preserve some pragmatic forms of cooperation between the UK and the EU is obvious and shared by the UK security establishment. There is a partial institutional precedent . When Denmark rejected participation in Europol in a popular referendum, the Danish government obtained a deal from the EU institutions which allows it to remain associated to Europol as a ‘third country’ (and a Member State). The bespoke Brexit reality may prove even more complex.

The Law & Politics of Brexit: Volume II

2020 ◽  
Keyword(s):  
Decision Making ◽  
European Union ◽  
Legal Framework ◽  
Comprehensive Analysis ◽  
The European Union ◽  
Trade Relations ◽  
The United Kingdom ◽  
The Uk ◽  
Financial Settlement ◽  
The Eu

This book provides the first comprehensive analysis of the withdrawal agreement concluded between the United Kingdom and the European Union to create the legal framework for Brexit. Building on a prior volume, it overviews the process of Brexit negotiations that took place between the UK and the EU from 2017 to 2019. It also examines the key provisions of the Brexit deal, including the protection of citizens’ rights, the Irish border, and the financial settlement. Moreover, the book assesses the governance provisions on transition, decision-making and adjudication, and the prospects for future EU–UK trade relations. Finally, it reflects on the longer-term challenges that the implementation of the 2016 Brexit referendum poses for the UK territorial system, for British–Irish relations, as well as for the future of the EU beyond Brexit.

scholarly journals Brexit and Territorial Preferences: Evidence from Scotland and Northern Ireland

2021 ◽  
Vol 51 (2) ◽  
pp. 186-211
Author(s):  
Lesley-Ann Daniels ◽  
Alexander Kuo
Keyword(s):  
Northern Ireland ◽  
Religious Background ◽  
Scottish Independence ◽  
The Uk ◽  
The Eu

Abstract Has the UK referendum to leave the EU (Brexit) affected territorial preferences within the UK? We draw on comparative theories of such preferences to address this question, as Brexit can be seen as a shock to a political unit. We test hypotheses in two key regions, Scotland and Northern Ireland, with original surveys fielded at a unique time (September 2019). We randomize making salient different Brexit scenarios and measure support for Scottish independence and unification with Ireland within each region. We find in Scotland the prospect of leaving the EU increases support for independence. This effect is pronounced among those who support the UK remaining in the EU. In Northern Ireland, religious background correlates highly with territorial views, and we find little evidence of Brexit or border-scenario effects. Our results contribute to the literature on decentralization processes and the EU, and provide evidence of when negative shocks affect such preferences.

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