State of Swexit/Brexit

•

0 likes•6 views

- The UK left the European Union on January 31, 2020, meaning European law is no longer applicable and UK regulations have been updated. - England, Wales and Scotland follow UKCA requirements under previous MDD, while Northern Ireland follows MDR requirements under UK NI. - There is an ongoing transition period until June 30, 2023 where CE, UKCA, and UKNI certificates are all accepted. However, only three notified bodies are currently UKCA approved in the UK. - A UK government consultation on future medical device regulation proposed 3-5 year transitional periods depending on existing certifications, but the new regulations have not been published yet. - Progress has been slow with a lack of approved bodies

Health & Medicine

SUMMARY
▪ I- Introduction
▪ II- Timeline
▪ III- Situation with the notified bodies
▪ V- results of the consultation
▪ VI- Conclusion

INTRODUCTION
What is Brexit and what it means ?
The referendum was done on 23.06.2016 regarding the United
Kingdom European Union membership and as a result UK left the
European union on 31.01.2020.
The European law is no longer applicable in UK
The regulations have been updated to reflect this
UK MDR 2002
The Medical Devices Regulations 2002 (legislation.gov.uk)
3

INTRODUCTION
What is the situation in UK?
England, Wales and Scotland
under MDD requirements
(UKCA)
North of Ireland under MDR
requirements (UK NI)
4

TIMELINE
5
Referendum
23.06.2016
UKCA starts
01.01.2021
End of the
transition
period
30.06.2023
Class I sterile
Registration
Registration of UK
responsible
person
01/01/2022
Class IIa and
IIb
IVD class B
Registration
01/09/2022
Class III and
IIb implantable
IVD class A
Registration
01/05/2022

TIMELINE
What certificate are accepted during transition period?
▪ CE certificates
▪ UKCA certificates
▪ UKNI certificates
6

SITUATION WITH NOTIFIED BODIES
Only 3 notified bodies UKCA approved in UK?
- SGS (MD and IVD)
- BSI (MD and IVD)
- UL (IVD only)
Approved bodies for medical devices - GOV.UK (www.gov.uk)
7

SITUATION WITH NOTIFIED BODIES
Guidance from MHRA
▪ Custom-made medical devices
▪ In-house manufacture of medical devices in Great Britain
▪ Vigilance
▪ Off label use
▪ Software applications
▪ Virtual manufacturing of medical devices
▪ Medicine and medical devices: product specific information
▪ Clinical investigation
Medicines, medical devices and blood regulation and safety: Medical devices
regulation and safety - detailed information - GOV.UK (www.gov.uk)
8

RESULTS OF CONSULTATION
Consultation from UK Government on the future regulation of
medical device
Started on 16/09/2021 and closing on 25.11.2021
Results published on 26.06.2022
17 chapters of questions to complete
Answers from the participants published in term of percentages and
comments
Position of the government
9

RESULTS OF CONSULTATION
Proposal of the government on the transitional period in the new
regulation
3 years for UKCA approved medical devices and 5 years for IVDs or until
certificate expires (which ever is sooner)
3 years for MDD, AIMD approved medical devices and 5 years for IVDs or
until certificate expires (which ever is sooner)
5 years for MDR approved medical devices or until certificate expires
(which ever is sooner)
10

CONCLUSION
Slow Progress
Not enough approved bodies
Lack of resources from MHRA
New regulation closer to MDR, When?
Lots of confusion
11

QUESTIONS
We have a valid CE mark certificate according to MDR 2017/745
can we continue to place the product on the market after
30.06.2023 for 5 years?
No because the current regulation requires UKCA from 01.07.2023
We have to wait for the new regulation to be published to check
from when a 5 years transition period is applicable
12

Brexit, Swixit, and Turkxit will impact the medical device market in Europe in the following ways: 1) After January 1, 2021, UK manufacturers will need to use a new UKCA marking and will lose recognition of their CE marks unless they take action. Northern Ireland will still recognize CE marks. 2) Switzerland's vote to end free movement could impact its mutual recognition agreement with the EU, requiring Swiss and EU manufacturers to take new steps for market access depending on if a new agreement is reached. 3) Unless Turkey's customs agreement is updated, Turkish manufacturers may lose access to the EU market after May 26, 2021 as the EU MDR and IVDR are not currently

UK REACH vs EU REACH, UK RoHS vs EU RoHS: Emerging Differences

raj takhar

The document summarizes key differences that are emerging between UK and EU chemical regulations, specifically UK REACH vs EU REACH and UK RoHS vs EU RoHS. It notes that while the UK systems initially mirrored the EU systems, divergence is occurring as the UK establishes its own independent framework. Differences highlighted include candidate substance lists, authorization processes, restricted substances, and obligations for companies. It also discusses areas of UK RoHS that are lagging updates from the EU, such as exemptions and product marking requirements, and that the UK will no longer be part of EU reviews and changes to RoHS.

This session will focus on the regulatory framework surrounding placing PFD’s on the market within the European Union and what is legally required by manufacturers in order to attach the CE mark or Wheelmark to their products. The session will then focus on the legislative changes for placing product on the market in the UK following Brexit with guidance on how to use the UKCA or Red Ensign mark and what is required in order to affix these marks to products for placement on the market. The presentation will also provide service offerings from UL which helps customers to meet their legal obligations when looking to place PFD products on the market in the UK and Europe. Speaker: Michael Kirkland, UL LLC, Senior Staff Engineer

Brexit webinar-2.12.2020

PwC Polska

If a company in Poland sells goods to customers in the UK after the Brexit transition period ends, it will be treated as an export from the EU and import into the UK. Both the Polish supplier and UK customer will need EORI numbers and may need to make customs declarations and pay import duties and VAT. The Polish supplier may need to register for UK VAT and set up UK VAT and Intrastat compliance processes. Both companies will likely need to adapt their ERP systems to handle the new cross-border trade flows and formalities. The allocation of responsibilities will depend on the delivery terms agreed between the parties.

Legal shorts 09.05.14 including FCA’s new MiFID II webpages and FTT

Cummings

This document provides a summary of recent legal and regulatory developments in the financial services industry. It discusses the FCA publishing new webpages on MiFID II, plans for an 11 country financial transaction tax to be implemented in 2016, the Council of the EU requesting agreement on the MiFID II legislative proposals, and the ECB publishing proposals for best practices for markets migrating to T+2 settlement in October 2014. It also briefly mentions several other topics, including the FCA publishing a policy statement on competition in RIE markets and launching a review of its enforcement decision-making processes.

Post-Brexit Pharmacovigilance in UK

Tepsivo

2019 at a Glance and What's Coming in 2020

EMMAIntl

The transition to the new EU MDR and IVDR regulations was a major focus in 2019, with concerns around limited guidance and the looming May 2020 implementation deadline. The US requested a three-year delay due to inadequate notified bodies and guidance. However, the EU commissioner has not changed the deadline. Brexit was also a major issue, with UK notified bodies set to lose accreditation and manufacturers needing to transfer certificates and authorized representatives to EU entities. Looking ahead to 2020, the FDA will finalize rules around ISO 13485 harmonization and digital health pathways.

Clinical Trial Regulation EU No. 536/2014

Ivowen Limited

The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.

Key current and future regulatory challenges in the Medical Device and/or IVD...

Diane Hatziioanou

This document discusses key current and future regulatory challenges in the medical device and IVD sector. Regulations are constantly evolving as the types of products in these sectors expand unpredictably. In the EU, directives have been amended over time and new regulations will be introduced. In the US, the 21st Century Cures Act aims to streamline FDA regulations but may allow unsafe devices on the market. The new EU regulations will increase requirements for clinical evaluation, post-market surveillance, and Notified Body involvement for most IVDs. Distinguishing medical software and ensuring data protection and quality submissions will also be challenges going forward.

Clinicals In The Uk 26 January 2009

Colin Rylett

BHBIA and ABPI AE Webinar 18 March 2021 - New Medical Device directive .pdf

filis2

The document discusses updates to joint BHBIA and ABPI guidance on collecting adverse events, product complaints, and serious product safety issues during market research, brought about by changes in UK medicines and medical devices law. Key points include: - The UK Medicines and Medical Devices Act 2021 elevated patient safety and established a new Patient Safety Commissioner role. - EU medical device regulations will apply in Northern Ireland from 2021/2022, while Great Britain regulations are still based on EU laws but have some changes. - The guidance was updated to reflect these legal changes and include definitions for medical devices and certificate of conformity holders. - Practical implications for companies include reviewing policies and licensing status of products to ensure compliance.

BREXIT – What it could mean for regulation and doing business in the UK

MJDelaMasa

This document discusses how Brexit could impact regulation and business in the UK. It analyzes how Brexit may affect regulations around economic crime, export controls, health and safety, and the environment. While the UK may have more flexibility without EU membership, the document suggests regulations in these areas are unlikely to change significantly in the short term, as the UK aims to remain competitive and meet international agreements. One impact could be less UK influence over EU-wide policies. Overall, the immediate impact of Brexit on regulations is uncertain and the UK approach will partly depend on future trade deals.

IAEG WG1 Spring 2022_ Introduction to UK REACH

raj takhar

Brexit Data Protection Update: The EU, US and UK Perspective

TrustArc

On 31 January 2020, the United Kingdom left the European Union. For the first time since its creation, a member state has decided to leave the common market, and for now, it is uncertain what the future holds for current privacy legislation. The new relationship between the UK and the EU will be negotiated in the course of this year, with the agreed transition period ending on 31 December. During this period, GDPR will apply as if nothing has changed. But what will happen after? This webinar will discuss the following topics: -What does Brexit mean from a data protection perspective? -What does it mean for the UK itself and for the position of the Information Commissioner’s Office? -What will be the impact of Brexit for data flows to and from the remaining 27 EU Member States and the countries of the European Economic Area? -And will there be any impact on the UK-US data flows?

HR Think Tank Series - DLA Piper Presentation - The People Issues of Brexit

Katie Barr

опис дерегуляція

tmelnik

The document discusses deregulation in Ukraine. It provides an overview of Ukraine's poor ratings in terms of doing business and economic freedom compared to other countries. It then discusses why a "guillotine" approach to deregulation that abolishes all regulations at once is not advisable, as Ukraine has international obligations and harmonized legislation with the EU. The document outlines a vision for deregulation reform through decreasing regulations and inspections while strengthening regulatory bodies. It proposes establishing a Better Regulation Delivery Office to review legislation sector by sector and guide deregulation efforts. Several initial deregulation initiatives and their results are highlighted.

Bashar H. Malkawi, UAE export controls: commitment commendable – but there’s ...

Bashar H. Malkawi

1. The document discusses various export control and compliance issues related to the coronavirus pandemic. It provides several news briefs on changes to export controls and licensing procedures by various countries and regulatory bodies as they work to address medical supply shortages and security concerns arising from the pandemic. 2. The UK export control body says it has measures in place to continue processing export licenses during the crisis, though on-site audits will be replaced with remote audits. India bans exports of ventilators and masks. 3. A health technology company calls on governments to drop export restrictions on critical medical materials to expedite the global pandemic response.

Clinical trial regulation in eu

Khushboo Bhatia

The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.

Economic operators and the exits

Erik Vollebregt

Brexit Webinar Series 3

U.S. Chamber of Commerce

This document summarizes a webinar presented by Allen & Overy on employment, data protection, and data transfers following Brexit. The webinar addressed how Brexit may impact these areas in the short and long term. In the short term, EU laws and free movement rights will continue to apply until the UK formally exits the EU. However, the long term implications are still uncertain as negotiations unfold over the next two years. The webinar also discussed steps companies can take now to prepare, such as auditing expatriate workforces and securing workers' immigration status.

What brexit means for business

Graeme Cross

The idea of creating a guide to the possible implications of Brexit came into being before the date for the Brexit referendum was set and the referendum campaign had begun. Now that the countdown to the June 23 vote is well underway, this has become a much more topical and current issue for everyone in the UK and I think that many more UK businesses are now engaged in active study and planning for Brexit scenarios.

In vitro Diagnostic Medical Devices

Walt Whitman

This document discusses the challenges and opportunities for in vitro diagnostic medical devices in the UK post-Brexit. Currently, the EU Withdrawal Bill would make EU directives like the Medical Device Directive part of UK law but most provisions of new regulations like the Medical Device Regulation would not be. The UK government has said it will comply with the key elements of the MDR and IVDR, but there is uncertainty around the final outcome of Brexit negotiations. Medical device companies need to take action to ensure they can continue sales in the EU after 2020 when the transition period ends. The UK may also create opportunities through mutually recognizing regulations with other countries like the US and developing its own guidelines.

The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in ...

State of Swexit/Brexit

Recommended

Recommended

More Related Content

Similar to State of Swexit/Brexit

Similar to State of Swexit/Brexit (20)

More from Greenlight Guru

More from Greenlight Guru (20)

Recently uploaded

Recently uploaded (20)

State of Swexit/Brexit