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
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
To improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU Market, the New Legislative Framework was adopted in 2008
improves market surveillance rules to better protect both consumers and professionals from unsafe products, including those imported from outside the EU:
- sets clear and transparent rules for the accreditation of conformity assessment bodies;
- boosts the quality of and confidence in the conformity assessment of products through stronger and clearer rules on the requirements for the notification of conformity assessment bodies;
- clarifies the meaning of CE marking and enhances its credibility;
- establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation.
The EU has and will continue to change dramatically over the coming years…In this session, two EU regulatory experts unpack the implications that Britain and Switzerland leaving the EU will have from a regulatory standpoint.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
To improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU Market, the New Legislative Framework was adopted in 2008
improves market surveillance rules to better protect both consumers and professionals from unsafe products, including those imported from outside the EU:
- sets clear and transparent rules for the accreditation of conformity assessment bodies;
- boosts the quality of and confidence in the conformity assessment of products through stronger and clearer rules on the requirements for the notification of conformity assessment bodies;
- clarifies the meaning of CE marking and enhances its credibility;
- establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation.
The EU has and will continue to change dramatically over the coming years…In this session, two EU regulatory experts unpack the implications that Britain and Switzerland leaving the EU will have from a regulatory standpoint.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Horizon 2020 Batteries: Information and Consortia Building Event - SlidesKTN
The workshop gave an overview of the forthcoming Horizon 2020 Battery related Calls representing a budget of around €337.5million. Horizon 2020 is the European Union’s Research and Innovation Programme.
In summary, the event covered:
- Gather information on forthcoming 2020 topics;
- Hear from current UK and European Battery Initiatives;
- Discuss and refine your project ideas with potential partners;
- Join consortia forming around forthcoming 2020 topics.
Find out more: https://ktn-uk.co.uk/news/ktn-and-innovate-uk-invite-you-to-an-information-and-consortia-building-event-for-horizon-2020-batteries
The Low Voltage Directive covers electrical equipment with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current.
Applies to equipment when placed on the market : new electrical equipment made by a manufacturer established in the Union or Electrical equipment, whether new or second-hand, imported from a third country
Voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.
For most electrical equipment, the health aspects of emissions of Electromagnetic Fields are also under the domain of the Low Voltage Directive.
The web page for the European Commission (Enterprise and Industry) states:
Construction Products Regulation (the CPR) is to ensure reliable information on construction products in relation to their performances. This is achieved by providing a “common technical language", offering uniform assessment methods of the performance of construction products.
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
Unraveling EU regulation for US Managers - Bovill New York BriefingBovill
Bovill - the UK financial services regulatory consultancy - held a breakfast seminar in New York for US investment managers and regulatory experts to 'unravel' EU regulation. For more information visit www.bovill.com.
Further information on the event is below:
Unraveling EU regulation for US Managers
Any financial services firm doing business in Europe needs a firm grasp of EU regulation.
Whether you are establishing an office in one country, marketing into several, or simply investing in a firm regulated in the UK, you will need to understand how EU-wide directives are translated into local rules.
Bovill – the London-based regulatory compliance experts – hosted a seminar in New York to give US firms an overview and update on European regulation.
The breakfast event covered:
The structure of the EU regulatory landscape – how EU directives are implemented by member states
The parallels and crossovers between EU and US regulation
The practical steps to consider, including a brief introduction to
- Alternative Investment Fund Manager Directive (AIFMD)
- European Markets Infrastructure Regulation (EMIR)
- Markets in Financial Instruments Directives (MiFID I & II)
Newsletter on PPE: Classification of PPE and CE Certification Process in EUJohn William
In the wake of the high demand for PPE and medical devices in the EU, Chinese suppliers have restarted exporting to Europe. However, the European Safety Federation has identified some suspicious CE certificates for both PPE and medical devices. The suppliers have either used fake documents or showed certificates by the wrong authorities. Since a CE mark is compulsory for all PPE and medical devices exported to Europe, this newsletter delves into product classification for PPE and medical devices and product classification by EU regulation. There are 2 regulations, namely, Regulation (EU) 2016/425, which is on PPE and Regulation (EU) 2017/745, which is on medical devices and accessories. It has been mandated that all medical products and PPE to be sold in the EU need to come under any of these regulations. All suppliers should have knowledge about the procedure for Certified CE Mark, the risk categories, classification of medical devices and types of notified bodies as well as their names in the regulations.
Vidrala announces the acquisition of Encirc
We are pleased to announce that today January 14, 2015, Vidrala has completed the acquisition of Encirc Ltd.
The Important of CE Marking Certification.pdfURS Labs
CE marking certification is a conformity marking that indicates a product's compliance with the essential health, safety, and environmental requirements set by the European Union (EU). The CE marking demonstrates that a product meets the applicable directives and regulations within the EU's single market. It is mandatory for many products sold or distributed within the EU and the European Economic Area (EEA).
F.A.Q on CE Marking of Construction Products_CertiMaCCertiMaC
The most frequently asked questions about CE marking of construction products.
As Notified Body no. 2685 CPR (EU) 305/2011 for the issue of Certification and Classification Certificates, CertiMaC carries out all the tasks assigned to it by the third party assigned to it in the evaluation and verification of the constancy of the benefit and for which it has been notified by the Ministries responsible: measure , examines, verifies, calibrates or otherwise determines the characteristics or performance of materials or construction products in terms of quality and efficiency.
Horizon 2020 Batteries: Information and Consortia Building Event - SlidesKTN
The workshop gave an overview of the forthcoming Horizon 2020 Battery related Calls representing a budget of around €337.5million. Horizon 2020 is the European Union’s Research and Innovation Programme.
In summary, the event covered:
- Gather information on forthcoming 2020 topics;
- Hear from current UK and European Battery Initiatives;
- Discuss and refine your project ideas with potential partners;
- Join consortia forming around forthcoming 2020 topics.
Find out more: https://ktn-uk.co.uk/news/ktn-and-innovate-uk-invite-you-to-an-information-and-consortia-building-event-for-horizon-2020-batteries
The Low Voltage Directive covers electrical equipment with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current.
Applies to equipment when placed on the market : new electrical equipment made by a manufacturer established in the Union or Electrical equipment, whether new or second-hand, imported from a third country
Voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.
For most electrical equipment, the health aspects of emissions of Electromagnetic Fields are also under the domain of the Low Voltage Directive.
The web page for the European Commission (Enterprise and Industry) states:
Construction Products Regulation (the CPR) is to ensure reliable information on construction products in relation to their performances. This is achieved by providing a “common technical language", offering uniform assessment methods of the performance of construction products.
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
Unraveling EU regulation for US Managers - Bovill New York BriefingBovill
Bovill - the UK financial services regulatory consultancy - held a breakfast seminar in New York for US investment managers and regulatory experts to 'unravel' EU regulation. For more information visit www.bovill.com.
Further information on the event is below:
Unraveling EU regulation for US Managers
Any financial services firm doing business in Europe needs a firm grasp of EU regulation.
Whether you are establishing an office in one country, marketing into several, or simply investing in a firm regulated in the UK, you will need to understand how EU-wide directives are translated into local rules.
Bovill – the London-based regulatory compliance experts – hosted a seminar in New York to give US firms an overview and update on European regulation.
The breakfast event covered:
The structure of the EU regulatory landscape – how EU directives are implemented by member states
The parallels and crossovers between EU and US regulation
The practical steps to consider, including a brief introduction to
- Alternative Investment Fund Manager Directive (AIFMD)
- European Markets Infrastructure Regulation (EMIR)
- Markets in Financial Instruments Directives (MiFID I & II)
Newsletter on PPE: Classification of PPE and CE Certification Process in EUJohn William
In the wake of the high demand for PPE and medical devices in the EU, Chinese suppliers have restarted exporting to Europe. However, the European Safety Federation has identified some suspicious CE certificates for both PPE and medical devices. The suppliers have either used fake documents or showed certificates by the wrong authorities. Since a CE mark is compulsory for all PPE and medical devices exported to Europe, this newsletter delves into product classification for PPE and medical devices and product classification by EU regulation. There are 2 regulations, namely, Regulation (EU) 2016/425, which is on PPE and Regulation (EU) 2017/745, which is on medical devices and accessories. It has been mandated that all medical products and PPE to be sold in the EU need to come under any of these regulations. All suppliers should have knowledge about the procedure for Certified CE Mark, the risk categories, classification of medical devices and types of notified bodies as well as their names in the regulations.
Vidrala announces the acquisition of Encirc
We are pleased to announce that today January 14, 2015, Vidrala has completed the acquisition of Encirc Ltd.
The Important of CE Marking Certification.pdfURS Labs
CE marking certification is a conformity marking that indicates a product's compliance with the essential health, safety, and environmental requirements set by the European Union (EU). The CE marking demonstrates that a product meets the applicable directives and regulations within the EU's single market. It is mandatory for many products sold or distributed within the EU and the European Economic Area (EEA).
F.A.Q on CE Marking of Construction Products_CertiMaCCertiMaC
The most frequently asked questions about CE marking of construction products.
As Notified Body no. 2685 CPR (EU) 305/2011 for the issue of Certification and Classification Certificates, CertiMaC carries out all the tasks assigned to it by the third party assigned to it in the evaluation and verification of the constancy of the benefit and for which it has been notified by the Ministries responsible: measure , examines, verifies, calibrates or otherwise determines the characteristics or performance of materials or construction products in terms of quality and efficiency.
Similar to Regulatory Framework in Europe & the Changes Related to Brexit for PFD's (20)
Always Ready – A Televised Life Jacket Wear CampaignNASBLA
This session will present recreational boating safety’s new 30-second life jacket TV commercial, Always Ready, scheduled for distribution on fishing programs this summer. The commercials are scheduled to broadcast more than 1,100 times on seven popular television networks including the Discovery Channel and the Outdoor Channel with a total audience of 238.1 million American households. Fishing is one of America’s most popular activities and anglers are one of boating’s most at-risk groups – in 2020 35.3% of fatal boating incidents occurred during fishing outings. The 30-second Always Ready commercials are supported by a longer web-based docu-mercial each reminding anglers to always wear a life jacket while boating. This short session will share the campaign’s creative content and early results. If time allows, additional Water Sports Foundation life jacket outreach materials will be presented encouraging attendees to use them freely!
Speaker: Jim Emmons, Water Sports Foundation, Executive Director
A Professional Angler’s Take on Boating SafetyNASBLA
Hunter will share how his boating accident resulted in a full-time career in the fishing industry. Hear how Hunter's experiences in the for-profit and tournament sector of the fishing industry have led to new communication techniques to effectively deliver the boating safety message. Join him for tips and tricks on how we can effectively market to our target demographics in order to reduce water related tragedies.
Speaker: Hunter Bland, Yamaha Motor Corporation, USA, Boating Safety Ambassador & Professional Bass Angler
One in five American families started a new outdoor habit during the pandemic, new research shows. The boating industry is booming as Americans turn to the water, and there’s no sign of the momentum slowing. With each of our programs, we work towards fulfilling our vision of helping create a safe experience for recreational boaters. The Safe Boating Campaign had to course adjust over the last two summers from an in-person grassroots outreach approach to a robust digital campaign, along with creative ways to reach boaters at launch points. The Life Jacket is the star of the show as you’ll see in our marketing content.
Speaker: Peg Phillips, National Safe Boating Council, Executive Director
Get the drift on a new program for boaters to assist the U.S. Coast Guard, local sheriff marine units and the Fish and Wildlife Commission. Aqua Alert would provide authorities with volunteers for those unique situations when extra “eyes on the water” would help during a lost at sea search. The inspiration, the Aqua Alert Pilot Program and the nation-wide vision, will be featured in this presentation. Bringing additional hope to water searches, these volunteers could be the answer to prayers.
Speaker: Judy Schink, Aqua Alert
Rapid Changing Cover Designs Enhance User WearabilityNASBLA
Some of the customer base has been reluctant to use life preservers due to uncomfortable fittings which in part are the result of heavier weight PFD UL-approved inflatable jacket materials that are needed for a functioning unit. Recent developments in technology have enabled manufacturers to provide a much lighter cell material. This along with flexibility in UL non-essential specifications, ensure a more comfortable fit and a higher rate of usage by those in the marketplace.
Speakers: Chris Semonelli, ESquared, Vice President of Sales & Marketing, and Wayne Walters, Kent Water Sports, LLC
How Product Evolution is Increasing Safety on the WaterNASBLA
Join this session to hear from WSIA’s Lee Gatts as he discusses recent legislation affecting the towed water sports industry and how new products in the market are increasing safety on the water but also creating new challenges to education and operation.
Speaker: Lee Gatts, Water Sports Industry Association (WSIA), Director of Government Affairs
The purpose of this presentation is to update the conference attendees on the R&D project that was conducted by UL to compile data on infant and child manikins currently incorporated into various life jacket certifications standards. With manikins not currently an acceptable path towards certification in North America, this project was conducted to start compiling in-water performance to compare to existing human subject data for currently USCG Approved devices and USCG reference test devices.
Speaker: Christopher James, UL LLC, Principal Engineering Manager
The Success & Future Plans for the Sea Tow Foundation's Life Jacket Loaner P...NASBLA
The Sea Tow Foundation’s Life Jacket Loaner Program began in 2008 and, while there were a number of other loaner programs operating decades before, the Sea Tow Foundation learned from them and has developed a robust program that is easy for local organizations to implement and maintain. As we enter our 14th summer, the Sea Tow Foundation has been able to establish life jacket loaner stations in all 50 states as well as in D.C., American Samoa and the Virgin Islands and that is something that no other life loaner program can claim. Our other successes will be presented as well as discussion of our future plans for the Life Jacket Loaner Program in this session.
Speaker: Gail Kulp, Sea Tow Foundation, Executive Director
LJA and the U.S. National Water Safety Action PlanNASBLA
The U.S. National Water Safety Action Plan (USNWSAP) will be a strategic, evidence-informed plan, created by experts in drowning prevention and informed by water safety stakeholders and practitioners from across the country, aimed at preventing drowning in the USA. Considering that most prevention needs to happen at the subnational level, the USNWSAP will be a model- based plan, focusing on providing guidance on what a model water safety community, county, and state should look like, as well as identifying national level activities that guide and support subnational efforts. The Life Jacket Working Group has identified 23 recommendations to be included in the USNWSAP.
Speaker: Christopher Stec
NASBLA was awarded a project through the US Coast Guard Nonprofit Organization Grant Program to create a series of webpages to address important information related to life jackets, specifically in response to the updates to the labels. Once completed – these webpages will be hosted on the Life Jacket Association (LJA) website.
Speaker: Taylor Matsko, Communications & Marketing Director, National Association of State Boating Law Administrators
State Boating Safety & Marine Law Enforcement OutreachNASBLA
We will briefly discuss how two players on the same team approach life jacket messaging. Our officers enforce life jacket laws and encourage the wearing of life jackets. As an outreach coordinator, we remind people of the legal requirements for life jackets when boating, but our main focus is on encouraging everyone to wear a life jacket. This is a different message than delivering the message of mandatory carriage or wear. Our goal is to give a better perspective on the opportunities and challenges the states have in the world of PFDs.
Speaker: Brian Rehwinkle, Florida Fish and Wildlife Conservation Commission, Outreach & Education Coordinator
Many ways to support street children.pptxSERUDS INDIA
By raising awareness, providing support, advocating for change, and offering assistance to children in need, individuals can play a crucial role in improving the lives of street children and helping them realize their full potential
Donate Us
https://serudsindia.org/how-individuals-can-support-street-children-in-india/
#donatefororphan, #donateforhomelesschildren, #childeducation, #ngochildeducation, #donateforeducation, #donationforchildeducation, #sponsorforpoorchild, #sponsororphanage #sponsororphanchild, #donation, #education, #charity, #educationforchild, #seruds, #kurnool, #joyhome
This session provides a comprehensive overview of the latest updates to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (commonly known as the Uniform Guidance) outlined in the 2 CFR 200.
With a focus on the 2024 revisions issued by the Office of Management and Budget (OMB), participants will gain insight into the key changes affecting federal grant recipients. The session will delve into critical regulatory updates, providing attendees with the knowledge and tools necessary to navigate and comply with the evolving landscape of federal grant management.
Learning Objectives:
- Understand the rationale behind the 2024 updates to the Uniform Guidance outlined in 2 CFR 200, and their implications for federal grant recipients.
- Identify the key changes and revisions introduced by the Office of Management and Budget (OMB) in the 2024 edition of 2 CFR 200.
- Gain proficiency in applying the updated regulations to ensure compliance with federal grant requirements and avoid potential audit findings.
- Develop strategies for effectively implementing the new guidelines within the grant management processes of their respective organizations, fostering efficiency and accountability in federal grant administration.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
What is the point of small housing associations.pptxPaul Smith
Given the small scale of housing associations and their relative high cost per home what is the point of them and how do we justify their continued existance
ZGB - The Role of Generative AI in Government transformation.pdfSaeed Al Dhaheri
This keynote was presented during the the 7th edition of the UAE Hackathon 2024. It highlights the role of AI and Generative AI in addressing government transformation to achieve zero government bureaucracy
A process server is a authorized person for delivering legal documents, such as summons, complaints, subpoenas, and other court papers, to peoples involved in legal proceedings.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Up the Ratios Bylaws - a Comprehensive Process of Our Organizationuptheratios
Up the Ratios is a non-profit organization dedicated to bridging the gap in STEM education for underprivileged students by providing free, high-quality learning opportunities in robotics and other STEM fields. Our mission is to empower the next generation of innovators, thinkers, and problem-solvers by offering a range of educational programs that foster curiosity, creativity, and critical thinking.
At Up the Ratios, we believe that every student, regardless of their socio-economic background, should have access to the tools and knowledge needed to succeed in today's technology-driven world. To achieve this, we host a variety of free classes, workshops, summer camps, and live lectures tailored to students from underserved communities. Our programs are designed to be engaging and hands-on, allowing students to explore the exciting world of robotics and STEM through practical, real-world applications.
Our free classes cover fundamental concepts in robotics, coding, and engineering, providing students with a strong foundation in these critical areas. Through our interactive workshops, students can dive deeper into specific topics, working on projects that challenge them to apply what they've learned and think creatively. Our summer camps offer an immersive experience where students can collaborate on larger projects, develop their teamwork skills, and gain confidence in their abilities.
In addition to our local programs, Up the Ratios is committed to making a global impact. We take donations of new and gently used robotics parts, which we then distribute to students and educational institutions in other countries. These donations help ensure that young learners worldwide have the resources they need to explore and excel in STEM fields. By supporting education in this way, we aim to nurture a global community of future leaders and innovators.
Our live lectures feature guest speakers from various STEM disciplines, including engineers, scientists, and industry professionals who share their knowledge and experiences with our students. These lectures provide valuable insights into potential career paths and inspire students to pursue their passions in STEM.
Up the Ratios relies on the generosity of donors and volunteers to continue our work. Contributions of time, expertise, and financial support are crucial to sustaining our programs and expanding our reach. Whether you're an individual passionate about education, a professional in the STEM field, or a company looking to give back to the community, there are many ways to get involved and make a difference.
We are proud of the positive impact we've had on the lives of countless students, many of whom have gone on to pursue higher education and careers in STEM. By providing these young minds with the tools and opportunities they need to succeed, we are not only changing their futures but also contributing to the advancement of technology and innovation on a broader scale.
2. What we are going to
discuss
• What is Brexit?
• Overview of the EU regulatory
environment
• Overview of the new U.K. legislation and
marks
• What this means for you
• How UL can help
10. EU and UKCA regulations and marks
EU
PPE Regulation Marine Equipment Directive
(EU) 2016/425 2014/90/EU
U.K.
Personal Protective Equipment Regulations
(Regulation (EU) 2016/425 as introduced to
U.K. law and amended)
Merchant Shipping (Marine Equipment)
Regulations 2016 SI 2016/1025
(EU) 2016/425 amended
by SI 2019/696
Merchant Shipping (Marine Equipment
(Amendment, etc.) (EU Exit)
Regulations 2019 SI 2019/470
11. How the regulations will work
• The requirements of the EU Regulations
and Directives became U.K. law and
remain substantially the same.
• Any responsible person or authorized
representative appointed must be based
in the U.K.
• Current EU Harmonised Standards
will be published as U.K. Designated
Standards.
• There is currently no system in place to
update Designated Standards should EN
standards be reviewed and amended.
• Market Surveillance remains the same
for the U.K.:
• PPE at work — Health and Safety
Executive
• PPE for private users — Trading
Standards
• Office for Product Safety and Standards
controls the strategy
12. PPE regulation implementation period
U.K.
• The United Kingdom Conformity Assessed (UKCA)
regime applies since Jan.1, 2021.
• Since Jan. 1, 2021, goods can be placed on the U.K.
market with the CE or UKCA marking until Jan. 1,
2023.
• Starting January 2023, goods can only be placed on
the U.K. market with the UKCA marking.
• UKCA marking Category 2 products require a Module
B certificate issued by a U.K. Approved Body.
• UKCA marking Category 3 products require a Module
B and either a Module C2 or D certificate issued by a
U.K. Approved Body.
• Until Jan. 1, 2023, UKCA marking can be applied by
a label affixed to the product or on accompanying
packaging.
EU
• Since Jan. 1, 2021, certificates issued by
U.K. Notified Bodies are no longer valid
for placing products on the EU market.
• EU Notified Bodies must establish an
entity and register as an Approved Body
in the U.K. to issue the UKCA marking.
13. Marine shipping regulations implementation
period
U.K.
• The United Kingdom Red Ensign
regime applies since Jan. 1, 2021.
• Since Jan. 1, 2021, goods can be placed
on U.K. flagged ships with a Wheel mark
or Red Ensign mark until Jan. 1, 2023.
• Starting January 2023, goods can
only be placed on U.K. ships with a
Red Ensign mark.
• Red Ensign mark products require
a Module B and either a Module D,E
or F certificate issued by a U.K.
Approved Body.
EU
• From Jan. 1, 2021, certificates issued by
U.K. Notified Bodies are no longer valid
for placing products on the EU market.
• EU bodies must establish an entity and
register as an Approved Body in the U.K.
to issue a Red Ensign mark.
14. Northern Ireland (the exception)
• The exception to the UKCA mark is
the Northern Ireland Protocol.
• The protocol was developed to avoid a
hard border between Northern Ireland
and Ireland.
• It remains with the consent of the
people of Northern Ireland, and a
vote will happen every four years.
The first vote will take place in 2024.
• Northern Ireland remains in regulatory
alignment with the EU, meaning:
• CE marked products continue to be accepted
in Northern Ireland.
• If a U.K. Approved Body carries out the
assessment for goods going to Northern
Ireland, then the UKNI mark is applied.
• Northern Ireland has unfettered access to the
rest of the Great Britain market, meaning CE and
UKNI products can be placed on the Great Britain
market from manufacturers in Northern Ireland.
• UKCA marked products alone cannot be placed
on the Northern Ireland market.
17. Major changes
that might
affect you
Manufacturers with U.K.
Notified Body:
Require certificates issued by
an EU27 Notified Body to place
goods on the EU market.
Manufacturers with EU
Notified Body:
To place goods on the U.K.
market, manufacturers will need
to obtain certificates from a
U.K. Approved Body this year.
19. How UL can help
UL International (Netherlands) B.V.
• Accredited by RvA to issue Module B/C2/D
under PPE Regulation (EU) 2016/425.
• Accredited by RvA to issue Module B/D/E/F
under Marine Equipment Directive
2014/90/EU.
UL International (U.K.) Ltd.
• Accredited by UKAS to issue Module B/C2/D
under PPE Regulation (EU) 2016/425
(EU Exit).
• Accredited by UKAS to issue Module B/D/E/F
under Merchant Shipping Regulations.
UL can provide market access services for
both the U.K. and EU at the same time.
Hello, welcome to the UL Webinar on Brexit and the UK conformity assessment procedures. This webinar will discuss the impact of Brexit and the new requirements for placing products on the market of the UK
IN this webinar we will discuss, What is Brexit?, an overview of the EU regulatory environment, an overview of the new UK legislation and marking and then what this means for our valued customers and how UL can help.
https://crc.ul.com/shared/download/AsedfZZQz2sAXBjR8BhHCTH2
Brexit was the withdrawal of the United Kingdom (UK) from the European Union (EU) which took effect 1st January 2021. This means that the UK no longer employs European laws and products being placed on the market must meet new UK legislator frameworks.
We firstly need to identify what constitutes the UK and EU.
The UK is here circled in red with the remaining EU 27 countries shown.
https://crc.ul.com/shared/download/cQy8kf7xruoVGZJuBqdfCk9L
The United Kingdom of Great Britain and Northern Ireland is a union of the countries made up of great Britain being England, Scotland and Wales with Northern Ireland.
We will next discuss and overview of the EU regulatory environment for PPE and Marine products.
Within Europe, Directives and Regulations make conformity assessment of certain products a requirement to ensure products are safe and perform as required.
Two such frameworks are the PPE Regulation and Marine Equipment Directive. The Personal Protective Equipment Regulation covers all PPE placed on the EU market and the Marine Equipment Directive covers products intended to be placed on EU flagged sea going ships.
The demonstration of meeting the PPE Regulation is by applying the CE mark whereas the MED uses the wheelmark.
We will now look at how the marks to be used under the new UK regulatory framework.
The PPE Regulation was brought into UK law and amended by Statutory Instrument 2019/696 which changed elements of the legislation for the UK market. Conformity with the UK legislation is demonstrated with the UKCA mark. The Marine Equipment Directive is brought into UK law with the Merchant Shipping (Marine Equipment) Regulations 2016 SI 2016/1025 and amended for Brexit under the (EU Exit) Regulations 2019 SI 2019/470. Compliance with the amended Merchant Shipping Regulations in the UK is demonstrated with the red ensign mark.
The EU legislation has been brought into UK law and amended for the UK market however the requirements remain substantially the same as the EU legislation.
Current EU harmonised standards will be published for use in UK law as UK Designated Standards and published on the UK Government website
Market surveillance authorities will remain the same within the UK.
Essentially manufacturers will now have to replicate the conformity assessment which is undertake for the EU in the UK before placing goods on the UK market. Products which needs conformity assessment by a certification body will be undertake by UK Approved Bodies appointed by the UK secretary of state.
UKCA:
The United Kingdom Conformity Assessment (UKCA) regime applies from January 1st 2021.
From January 1st 2021 goods can be placed on the UK market with a CE or UKCA mark until 1st January 2022.
From January 2022 goods can only be placed on the UK market with a UKCA mark.
UKCA mark category 2 products require a Module B certificate issued by a UK Authorised Body.
UKCA mark category 3 products require a Module B and either Module C2 or D certificate issued by a UK Authorised Body.
Until January 1st 2023 the application of the UKCA can be applied by a label affixed to the product or on accompanying packaging.
EU:
From 1st January 2021 certificates issued by UK Notified Bodies are no longer valid for placing products on the EU market.
EU bodies must establish an entity and register as an Approved Body in the UK to issue a UKCA mark.
UK:
The United Kingdom Red Ensign regime applies from January 1st 2021.
From January 1st 2021 goods can be placed on UK flagged ships with a Wheel mark or Red Ensign Mark until 1st January 2023.
From January 2023 goods can only be placed on UK ships with a Red Ensign mark.
Red Ensign mark products require a Module B and either Module D/E/F certificate issued by a UK Authorised Body.
EU:
From 1st January 2021 certificates issued by UK Notified Bodies are no longer valid for placing products on the EU market.
EU bodies must establish an entity and register as an Approved Body in the UK to issue a Red Ensign mark.
Northern Ireland remains the exception to the UKCA mark. To avoid a hard border in Norther Ireland, CE marked goods will continue to be allowed to be place on the NI market. Goods may also be placed on the NI market under the UK legislation using the UKNI mark conducted by a UK approved body acting as a Notified Body under EU law.
The table on screen now shows the accepted marking for different markets from the UK government website.
What does this all mean for you?
Manufacturers who previously placed products on the market with a UK Notified Body can no longer use this certificate and must transfer to an EU 27 Notified Body to mark products with the CE mark.
Manufacturers with CE marks from EU Notified Bodies will need to obtain UK certification from a UK approved body to place products on the UK market form the dates given in previous slides.
How can UL help you comply with the new legislatory environment?
UL is accredited as both an EU Notified Body in the Netherlands and as a UK Approved and can issue certificates for Europe and the UK under the PPE and Marine environment.
Should you have any questions, please feel free to get in touch and we will respond as soon as possible.