Product safety standards, labeling requirements, mandatory documents and lab testing when importing and selling products in the European Union (EU). If you found this video useful, click here to learn how we can help you: https://www.chinaimportal.com/all-categories/
Views: 597 ChinaImportal.com
Which Equipment Products that Need CE Marking Certification? Not all products sold in the European Union need to bear CE marking. CE marking is only mandatory for those products which fall under the scope of one or more of the European CommissionNew Approach Directives What products need a CE marking? CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. Such products fall under one or more Directives which determine the specific requirements that the product must meet to be CE marked. The full list of these product categories is below: The CE marking is required only for products for which a CE marking directive or regulation has been adopted. There are directives regulations for the following types of products please note that one or more directive regulation can apply to a single product: Number 1. Active implantable medical devices Number 2. Appliances burning gaseous fuels Number 3. Cableway installations designed to carry persons Number 4. Eco-design of energy-related products Number 5. Electromagnetic compatibility Number 6. Equipment and protective systems intended for use in potentially explosive atmospheres Number 7. Explosives for civil uses Number 8. Hot-water boilers Number 9. Household refrigerators and freezers Number 10. In vitro diagnostic medical devices Number 11. Lifts Number 12. Low voltage machinery Number 13. Measuring instruments Number 14. Medical devices Number 15. Noise emission in the environment Number 16. Non-automatic weighing instruments Number 17. Personal protective equipment Number 18. Pressure equipment Number 19. Pyrotechnics Number 20. Radio and telecommunications terminal equipment Number 21. Recreational craft Number 22. Safety of toys Number 23. Simple pressure vessels CE marking is not required for items such as: 1. Chemicals 2. Pharmaceuticals 3. Cosmetics and foodstuffs Before placing the CE marking on your product, you must meet certain legal requirements - see how to place a CE marking on a product. Products that are not covered by the European CE marking directives may fall within the scope of other European or national legislation. If there is no specific legislation, the General Product Safety Directive 2001/95/EC may apply. This European Directive requires that products are safe, but it does not require any marking. EU-CERT has Certified thousands of products to support CE Marking certification Declarations of Conformity DoC for equipment safety, electromagnetic compatibility, and energy efficiency. Contact us today to tap the experience and skill of the EU-CERT Certification Expert team. You can feel free to call our CE Certification Specialists – Free 24 Hour Advice and Support https://eu-cert.org/which-equipment-products-need-ce-marking-certification/ People also ask: How do I get CE certification? Is the CE mark mandatory? What is meant by CE certification? What is CE marking on steel? Products that need CE marking What products need CE marking? Do your products need CE marking? CE-Marking: Does my product need CE Marking? Searches related to Which Equipment/ Products Need CE Marking Certification?
Views: 170 ECT European
"New Approach" Directives set out the essential requirements, written in general terms, which must be met before products may be sold in the European Community. European harmonised standards provide the detailed technical information to meet the essential requirements. For more information about CE marking visit our website: http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking
Views: 2903 TÜV SÜD Product Service UK
Hong Kong Toys Industry Conference 2012 -- Latest Product Safety Directives of the Toys Industry, was held concurrently with the HKTDC Hong Kong Toys & Games Fair. Christian Wetterberg, Director of Governmental Affairs from Lego and Technical Expert from Toy Industries of Europe, talked about "EU Toy Safety Directive: Safety Assessment". HKTDC Hong Kong Toys & Games Fair: http://www.hktdc.com/fair/hktoyfair-en/ Hong Kong Toys Industry Conference 2012: Latest Product Safety Directives of the Toys Industry: http://www.toyshk.org/news-01.php?page=1&cayear=2012&camonth=01&nid=79 Toy Industries of Europe: http://www.tietoy.org/
Views: 433 HKTDC
Hong Kong Toys Industry Conference 2012 -- Latest Product Safety Directives of the Toys Industry, was held concurrently with the HKTDC Hong Kong Toys & Games Fair. Maureen Logghe, Policy Officer of Directorate General for ENTERPRISE from European Commission, talked about "EU Toy Safety Directives: Scope and Obligations". HKTDC Hong Kong Toys & Games Fair: http://www.hktdc.com/fair/hktoyfair-en/ Hong Kong Toys Industry Conference 2012: Latest Product Safety Directives of the Toys Industry: http://www.toyshk.org/news-01.php?page=1&cayear=2012&camonth=01&nid=79 European Commission: http://ec.europa.eu/index_en.htm
Views: 696 HKTDC
As of 11 May 2013 the 2010/32/EU Directive will come into effect. In a nut-shell: Registered providers are required to train and assess staff in the correct use and disposal of sharps and sharps safety devices. The practice of recapping shall be banned with immediate effect (introduced in the UK in May 2010: Prevention of sharps injuries in hospitals and the healthcare sector). Studies in the UK suggest that up to 56% of dental practices experience at least one needlestick injury per year, and that as many as 30% of these constitute a moderate or high risk of transmission of infection. ASTEK INNOVATION: INSAFE SAFETY SYRINGE The InSafe Dental Syringe is a new and totally unique anesthetic safety system. It's a low cost, simple way to protect dental clinical staff. InSafe's patented syringe and sharps container ensure that the contaminated needle is never exposed except when required for the injection. Dismantling the needle at the end of procedure is one-handed and poses no risk to the user. No other system offers this level of protection. . The only reusable syringe that protects staff from start to finish. . Meets Directive 2010/32/EU legal requirements for all dental surgeries to have a safe disposal of sharps procedure. . Best New Product Winner - The Dental Awards 2009. . Doesn't require any change of technique by the dentist. . Feels and weighs like a traditional syringe. . Works with all standard dental needles. . Available in 1.8 or 2.2 ml format. . Quick and simple cartridge change without dismantling device. . Can be fully dismantled for sterilisation. . Easy and safe needle disposal in the InSafe Sharps container. . Versatile system with full choice of interchangeable aspiration options and handle design. For further information, please contact: Panadent Ltd, on 01689 881788 or visit www.panadent.co.uk
Views: 4504 PP G
The REACH Regulations replace a number of directives with a single system EU regulation concerning the registration, evaluation, authorisation and restriction of chemicals. The Regulations are in place to provide a high level of protection to human health and the environment from the use of chemicals and to make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use.
Views: 3889 3M UK & Ireland
CE marking is a process that allows manufacturers to declare that their product complies with all applicable European Community Directives. A declaration of conformity, issued by the manufacturer or its authorised representative, allows the product to be marked with the CE mark and offered for sale in the EU. Machinery may not be offered for sale in the EU without CE marking unless it falls within one of the Machinery Directive exclusion categories. CE marking according to the requirements of the Machinery Directive is mandatory for machines offered for sale in the European Union. The CE marking process is often relatively simple, but requires an interpretation of the requirements of the directives applicable to the product to be marked and, in the case of the Machinery Directive, a risk assessment against the applicable Essential Health and Safety Requirements. This webinar introduced the European Machinery Directive, other applicable Directives and the CE marking process to help you meet your legal requirements.
Views: 636 TÜV SÜD Product Service UK
This presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment placed on the European Market. The material is intended to inform those that do not already understand CE marking requirements and to clarify and reinforce the understanding of those already familiar with the concepts. This presentation is intended for anyone involved in the design, development, production and selling of products that are placed on the European market. This includes, design engineers, project managers, engineering managers, approvals engineers, quality managers, sales managers. In particular those who sign the Declaration of Conformity. For more information visit: http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking Find out about our training courses here: www.tuv-sud.co.uk/training
Views: 6923 TÜV SÜD Product Service UK
The presentation was delivered by our eyewear expert Candia Tse and cover such important points as: • Classification of eyewear products for the purposes of compliance • EU legislations regulating eyewear safety • What REACH regulations mean for eyewear brands
Views: 163 QIMA
Learn about the PED (Pressure Equipment Directive), the Fluid Group Classification, and the forthcoming changes. Look at the latest timescales and how you can prepare your business for them. Learn more at: http://www.bsigroup.com/en-GB/our-services/product-certification/ce-mark/eu-directives/new-pressure-equipment-directive/ Get more videos like this: http://bit.ly/subscribe-to-bsi-youtube-channel
Views: 1640 BSI Group
The amended Machinery Directive (2006/42/EC) came into force in December 2009 and has one of the broadest scopes of all the CE Marking Directives. This webinar will show the process involved in CE Marking to the Machinery Directive, including carrying out risk assessments, the use of EN Standards and producing the required documentation. For more infromation please visit our website: http://www.tuv-sud.co.uk/uk-en/industry/manufacturing-industrial-machinery To find out about our other available training courses, please click here: http://www.tuv-sud.co.uk/uk-en/activity/training
Views: 8207 TÜV SÜD Product Service UK
A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of the official languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.
Views: 2278 Obelis Group
Video taken at in-cosmetics Asia – http://www.asia.in-cosmetics.com Speaker is Lin Yang, Toxicologist, Delphic HSE Solutions (HK) Limited more info at http://www.delphichse.com/ To introduce a practical approach to compliance with the EU Cosmetic Regulation 1223/2009, this presentation will cover: EU Cosmetic Regulation 1223/2009 * Cosmetic definitions and borderline products * Structure of the regulation and ingredient restrictions Responsible Person (RP) and the role of RP * Product Information File (PIF) preparation * Product labelling and claims review * CPNP notification and post market surveillance Watch this presentation to get more understanding of the EU cosmetic regulations and the regulatory requirements on placing cosmetic products into EU market. in-cosmetics Asia is the leading exhibition and conference in Asia Pacific for personal care ingredients – takes place in Bangkok, Thailand in October/November and is focused on personal care raw materials and manufacturing – more info at http://www.asia.in-cosmetics.com
Views: 183 in-cosmetics
One of the highlights at the HKTDC Hong Kong Toys & Games Fair, industry leaders addressed the issue of the "Latest Product Safety Directives of the Toys Industry" at the popular Hong Kong Toys Industry Conference. To see the video of the whole conference, visit www.hktdc.com/hktoyfair now!
Views: 156 HKTDC
Danish Minister for Environment and Nordic Co-operation, Karen Ellemann, speaks at the Nordic Baltic Workshop on the Implemantation of the EU Toy Safety Directive. Copenhagen 19 May 2010. Workshop organised by the Nordic Association of Toy Manufacturers and DI - Confederation of Danish Industry
Views: 125 kamdk1
The new Radio Equipment Directive is currently going through its final stages of approval before being published in the Official Journal of the European Union, two years after which it will replace the existing Radio and Telecommunications Terminal Equipment (R&TTE) Directive. This webinar, hosted by Les Rowland of TÜV SÜD BABT, discusses some of the key changes introduced in the new Directive, which bring it into alignment with the New Legislative Framework. Les also discusses equipment that no longer falls within the scope of the Radio Equipment Directive, as well as equipment that is now included. To download a copy of the presentation slides and the Q&A session, which includes answers for all of the questions submitted during the webinar, visit: http://www.tuv-sud.co.uk/uk-en/resource-centre/webinars/webinar-downloads For more information about the Radio Equipment Directive visit: http://www.tuv-sud.co.uk/uk-en/about-tuev-sued/tuev-sued-in-the-uk/tuev-sued-babt/product-certification/radio-equipment-directive-red-2014-53-eu
Views: 1303 TÜV SÜD Product Service UK
The Physical Agents Directive (EMF) 2013/35/EU is one of a number of Directives that introduces measures to encourage improvements in the safety and health of workers at work across the EU, specifically regarding the exposure of workers to the risks arising from electromagnetic fields. Member State legislation is due by 1 July 2016 therefore industries have time to consider their health & safety arrangements and prepare/update their policies and procedures to comply with the PAD (EMF). Technically the PAD (EMF) adopts guidance from the international body ICNIRP but has some different approaches. A ‘Practical Guide’ will be produced to assist with meeting the PAD (EMF) but is not yet issued so in the meantime we will look at the PAD (EMF) requirements and their expected implementation.
Views: 111 TÜV SÜD Product Service UK
How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product? There are a series of steps outlined below for CE mark approval. Depending on your product and the nature of the risks it presents: Number 1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them. Number 2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s). Number 3. Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below: Module A: internal production control Module Aa: intervention of a Notified Body Module B: EC type-examination Module C: conformity to type Module D: production quality assurance Module E: product quality assurance Module F: product verification Module G: unit verification Module H: full quality assurance The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking. A Notified Body is usually able to offer some of the services required: Number 1. Product testing Number 2. Type examination certificate issue Number 3. Technical File and design dossier evaluation Number 4. Surveillance of product and quality system Number 5. Identification of standards If your products need to be certified by a Notified Body, then you will need to do as the follows: Number 1. Select the applicable product standards and test methods for your product and select a Notified Body. Number 2. Establish an Authorized Representative in the European Union for your product. Some directives require that a manufacturer designates in the European Union an authorized representative to produce Technical File in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities. Technical File: The directives require for many products that a Technical File be prepared by the manufacturer. The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards. Number 3. Prepare a Declaration of Conformity. The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list the directives and standards that your product conforms to, product identification, the manufacturer's name, address, and signature. Number 4. Register your product in EU Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market. Number 5. Affix the CE Marking to your product. There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking Thanks For Watching EU-CERT has Certified thousands of products to support CE Marking certification Declarations of Conformity DoC for equipment safety, electromagnetic compatibility, and energy efficiency. Contact us today to tap the experience and skill of the EU-CERT Certification Expert team. You can feel free to call our CE Certification Specialists – Free 24 Hour Advice and Support https://eu-cert.org/how-to-get-ce-marking-certification-for-my-product/ Searches related to How To Get CE Marking Certification For My Product? how to get CE certification CE marking self-certification how to get CE certification in India CE certification cost CE marking self-certification pack what products need CE marking CE marking guide CE marking exemptions
Views: 319 ECT European
https://www.emcbayswater.com.au/ CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards. Electrical and electronic products sold in the European market must be CE marked. The application of the CE mark requires compliance with various European directives depending on the type of product. Commonly applied EU Directives include EMC, electrical safety (LVD), Radio and Telecommunications (R&TTE), Machine Directive and Medical Devices. Follow the link or contact us today to find out how best EMC Bayswater can help with your CE EMC compliance testing, approvals and certifications.
Views: 409 EMC Bayswater Pty Ltd
Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet the said requirements. This video will walk you through to help you understand the applicable adverse event reporting requirements and remain in conformity with the requirements in EU, Canada and US. This video will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/QhNV/
Views: 891 GlobalCompliance Panel
T/I: 10:30:15 The European Union's quest for a standardized Europe in just about all aspects of life is causing something of a stir in the Netherlands, where one of the country's most important symbols is under the microscope. Under an EU directive, the humble wooden clog shoe is undergoing tests to ensure it passes strict safety standards for workers. Workers in the Netherlands have continued to wear clogs, even though they have been illegal in the workplace since 1995 when the EU began setting product standards for its 15 member states. Researchers have spent two months testing the clogs for all aspects of safety. Tests found the clogs, which date to the mid-1300's, outperformed work boots, vindicating clog manufacturers who have accused the EU of tampering with tradition, threatening the industry and a way of life. Just two of the country's 35 clog manufacturers have undergone testing and been awarded EU safety certification. But developing the common standard has cost the association of clog manufacturers thousands of dollars. SHOWS: NETHERLANDS, RECENT Man wearing clogs rides bicycle home; vs constructions workers on building site wearing clogs; SOT Noud van der Velden, construction worker in Dutch: "That is warm and dry on my feet and for safety. If a stone falls on my foot, it doesn't go through the shoe"; WS EU Commission Brussels SOT Stewart Sanson, Spokesman for the European Union's Standardization Committee; "Remember, we are making European standards to support the European Union directives. Really our job is to make sure the workers are protected and that goods can be exchanged throughout Europe. I accept that now and then there are one or two difficult circumstances, that we need to go into and to look at to see what it is causing the problem - what kinds of factories, what kind of dangerous materials. I do not imagine for one moment that someone, for example, in a market place cannot wear clogs. We are talking about factories where they are melting metal at high temperatures, where there can be dangerous chemcials. I think that most reasonable people would accept that probably in those circumstances that clogs might not provide sufficient protection"; NETHERLANDS. VS interior Van der Vleuten clog factory in Liempde; vs production line, machines carving clogs; painted clogs; SOT Cor Van der Vleuten, owner of the clog factory in English: "It is just another sticker on the product that cost us more money and in the end it costs the client more money"; Exterior souvenir shop window, showing clogs; Exterior (TNO) The Netherlands Organization for Applied Scientific Research; VS Jan Broeders testing (precsion) clog; Broeders prepares a test machine; CU clog being tested; machine drops and smashes clog; pan smashed clogs; MS man hand painting clog at Van der Vleuten clog factory; 2.51 You can license this story through AP Archive: http://www.aparchive.com/metadata/youtube/1796b0e01b50399924ff85208b8ccd16 Find out more about AP Archive: http://www.aparchive.com/HowWeWork
Views: 196 AP Archive
Medical Device Regulation Training - Within less than 10 minutes you'll learn how to classify a Medical Device in Europe with the new Medical Device Regulation MDR 2017/745. This step is important for the Medical Device Industry. I'll tell you How many classes it exists, why this is important. I'll also inform you about all the rules that exist and in the end, you'll have some exercises to test your knowledge. I will also provide you with a free form to download so you can be more efficient when you'll have to classify your product. Look at the notes below for the link *************************** Links ************************** - Participate to the free Mini-Course on MDR 2017/745 (6 days challenge) https://easymedicaldevice.com/mdr - Free Form to classify your medical device https://easymedicaldevice.com/class - Article on Medical Device Classification in Europe https://easymedicaldevice.com/mdclass ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice -------------------------------------------------------------------------------------------- Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 820 Easy Medical Device
The Physical Agents Directive (EMF) 2013/35/EU is one of a number of Directives that introduces measures to encourage improvements in the safety and health of workers at work across the EU, specifically regarding the exposure of workers to the risks arising from electromagnetic fields. Member State legislation is due by 1 July 2016 therefore industries have time to consider their health & safety arrangements and prepare/update their policies and procedures to comply with the PAD (EMF). Technically the PAD (EMF) adopts guidance from the international body ICNIRP but has some different approaches. A 'Practical Guide' will be produced to assist with meeting the PAD (EMF) but is not yet issued so in the meantime we will look at the PAD (EMF) requirements and their expected implementation.
Views: 273 TÜV SÜD Product Service UK
http://www.ceway.eu This clip presents the labelling requirements for products packaged in aerosol dispensers in the EU. These requirements are represented in the aerosol dispensers directive 75/324/EEC and its updates -- directives 94/1/EC and directive 2008/47/EC.
Views: 2593 CE.way Regulatory Consultants Ltd.
This video provides an introduction to the ErP Directive, Energy Label and will provide information on the new Computer regulation. The 'Energy related Product' Directive (ErP) is the European approach of saving energy which is complemented with various 'Implementing Measure' as well as a new 'Energy Label' directive with its various 'Delegated Acts'. For more information about CE marking and the ErP Directive: -http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking -http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking/eup-directive
Views: 2389 TÜV SÜD Product Service UK
On 26 September 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council on medical devices and in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives (MDD, AIMD, IVD). The MDD and AIMD will be incorporated into one single regulation, the MDR. For current IVD directive, the new regulation will be the IVDR. The new Medical Device Regulation affected all kinds of medical devices, from home-use items like sticking plasters and contact lenses, to X-ray machines, pacemakers, breast implants and hip replacements. The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. Ensuring compliance to the new regulations is critically important for legal manufacturers in order to CE mark their devices in Europe. Manufacturers however will also benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
Views: 8596 TÜV SÜD Product Service UK
Confused about the ever changing EU Directives and Regulations? Watch this Video and email [email protected] for your free copy of the Matrix
Views: 113 phoenixtechgroup
The CE marking is required for many products. It states that the product is assessed before being placed on the market and meets EU safety, health and environmental protection requirements. Source: http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/index_en.htm
Views: 2294 РИЦ- Санкт-Петербург
Course ID: 145 Course Description: This course provides a clear and comprehensive understanding of the EU regulatory model. It focuses on key principles essential to both ensuring the safety of medical devices and bringing them to market efficiently. This course covers the following topics: - EU directives - Key players, definitions, and classifications within the EU Regulatory System - Conformity assessment procedures - Quality system requirements and evaluations using ISO 14155 (including directives 93/42, 90/385, and subsequent updates) - Related product-specific directives - Combination product requirements - Interactions with directives for pharmaceutical products - Tissue engineering products - Additional products taken from the demarcation guide Learn more at: http://www.wmdo.org/course-detail.aspx?id=57
Views: 349 WMDO
In July 2012, pharmacovigilance legislation went into effect across the European Union (EU) as a result of changes set out in Regulation (EU) No1235/2010: and Directive 2010/84/EU. The legislation is underpinned by a European Commission (EC) Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. Are you confident your pharmacovigilance operations will meet the EU's latest expectations for compliance? Do you understand the processes needed to perform adequate risk assessment? Not knowing which systems and processes you must have in place for the European pharmacovigilance requirements could have significant consequences for your product. You must be sure you have the understanding you need to be able to work to EU standards and have implemented regulatory requirements for signaling and risk management. This web seminar is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the European pharmacovigilance requirements. We will address: Audits and inspections; ADR reporting and signal management; Periodic Safety Update Reports; risk minimization; Risk Management Plans; and post authorization studies.
Views: 122 Kathy Barnett
In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action requiring Medical Device Manufacturers to “proactively collect and review experience gained from their devices placed on the market.” With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR. While Post Market Surveillance was always a regulatory requirement, the new measures introduced require that manufacturers follow on specific directions, tightening the links between PMS activities and other processes. Few examples of these new measures are: the issuance of Periodic Safety Update Reports (PSURs) to Notified Bodies, the update of the Vigilance and PMS procedures per the new requirements, and the increased involvement of Notified Bodies and authorities in the process.
Views: 2780 GMED
Find out why BSI is trusted by our clients as their Notified Body for CE marking. We can help you gain access into the European market by ensuring your product meets all CE marking requirements. CE marking allows you to legally market and distribute your product within the European Market, and declares that your product complies with all applicable European Directives and Regulations. Learn more: http://www.bsigroup.com/en-GB/our-services/product-certification/ce-mark/ Get more video updates: http://bit.ly/subscribe-to-bsi-youtube-channel
Views: 5994 BSI Group
Understanding and planning your transition to the new regulations is key to ensuring compliance for your medical devices. Kevin Madden, BSI Medical Device Product Specialist, shares his expertise at Medical Technology Ireland about the transition to the EU Medical Device Regulations. Follow Compliance Navigator Medical Device Blog and stay up to date with the new Medical Devices / IVD Regulations and innovations in the medical device industry. https://compliancenavigator.bsigroup.com/en/community/blog-page/
Views: 1644 BSI Group
Slightly optimitic outcome of WECF press conference on toys safety at European Parliament this January http://www.wecf.eu/english/articles/2012/01/toys_conference_brussels.php Following a press conference and toys test on-site in the European Parliament organised by Women in Europe for a Common Future (WECF) end of January, WECF says there are indications that political will is increasing to enhance the European Toys Safety Directive. Despite the new Toys Safety Directive, many toys in the EU still contain a high concentration of hazardous chemicals such as phthalates, brominated flame retardants and heavy metals. Children in Europe are at risk of having retarded brain development or developing cancers later in life due to low-dose childhood exposure to hazardous substances, if the legislations on toys, pesticides, cosmetics and chemicals are not improved. WECF reports that there are indications that the Danish EU presidency is interested in reviewing the Toys Safety Directive, and that the European Commission is planning to revise the limits for lead in toys. WECF calls for toxic-free toys in Europe and highlights eight problems with the current Toys Safety Directive. However, there are indications that political will is increasing to enhance the directive but still we see many problems regarding chemicals in toys as unfortunately we have not heard any new measures taken by the industry.
Views: 144 WECF International
Hear Nathan Shipley, BSI’s Certification Manager, talk about the PPE Directive landscape and the changes to expect in Regulation scope, categories and modules. Look at the latest timescales for the changes and how you can prepare your business for them. To learn more visit: https://www.bsigroup.com/en-GB/our-services/product-certification/industry-sector-schemes/personal-protective-equipment-ppe/PPE-regulation-revision-uk/ Connect with BSI: Follow BSI on YOUTUBE: http://bit.ly/BSIYouTubeSubscribe Follow BSI on LINKEDIN: http://bit.ly/BSILinkedInHome Follow BSI on TWITTER: http://bit.ly/BSITwitterFeed Follow BSI on FACEBOOK: http://bit.ly/BSIFacebookTimeline
Views: 284 BSI Group
Eurotech is Providing CE mark certification Service in all over India.The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all of the Directives relating to that product. Introduction to CE Marking What is the CE Mark / CE Marking? When is the CE mark required? Who should undertake CE marking? What does the CE mark mean? How do I CE mark my product? What is the CE marking process? How to Get CE Mark Certification for Medical Devices Sold in Europe ce mark ce directive ce marking directive ce certification ce marking certification ce marking requirements what is ce ce marking uk ce india You can contact Us For More Information if you are interested to get Ce mark your product Best Regards, Puneet Sharma Email ID: [email protected] http://www.eurotechworld.net/cemarking.php https://plus.google.com/u/0/+EurotechworldNet/posts https://www.facebook.com/EurotechworldCertifications
Views: 748 Puneet Sharma
Brief video animation explaining how to get the CE mark for European regulatory compliance. There are 25 directives that may apply to a product in order to satisfy the mandated compliance requirements for Europe under the CE mark scheme. It is a self declaration process, were evidence of compliance to the applicable directives and subsequent standards is require. A single declaration is required along with affixing the CE logo correctly to each product. For further information please visit our site: https://www.emcbayswater.com.au
Views: 428 EMC Bayswater Pty Ltd
A technical file is your documented evidence to show that a product properly complies with the requirements of the directives which apply to it. For more information on CE marking visit: http://www.tuv-sud.co.uk/uk-en/activity/product-certification/european-approvals/ce-marking
Views: 10270 TÜV SÜD Product Service UK
Jones Seminar on Science, Technology, and Society "The Impact of the EU's Restriction of Hazardous Substances Directive" A lecture presented by Ron Lasky, Instructional Professor at Thayer School, where he is also the Director of the Cook Engineering Design Center and the founder and Director of Thayer's Six Sigma Program. Friday, April 30, 2010
Views: 953 Thayer School of Engineering at Dartmouth
The EU's Tobacco Products Directive (TPD) was agreed on Wednesday (18 December), after the issue of whether refillable e-cigarettes should be regulated as general sale or medicines has been solved. While a compromise was reached between the Parliament and the Council on Monday night (16 December), it still had to be approved by EU member states as it went beyond the mandate given to the Lithuanian government, negotiating on behalf of the EU countries.
Views: 186 EURACTIV
Rx-360 is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers. The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization with the mission to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain.
Views: 160 Rx-360 Consortium
Hong Kong Toys Industry Conference 2012 -- Latest Product Safety Directives of the Toys Industry, was held concurrently with the HKTDC Hong Kong Toys & Games Fair. DeWane Ray, Assistant Executive Director of Office of Hazard Identification and Reduction from the US Consumer Product Safety Commission, talked about "CPSC's Latest Toy Regulations and Developments, Including Testing and Certification". HKTDC Hong Kong Toys & Games Fair: http://www.hktdc.com/fair/hktoyfair-en/ Hong Kong Toys Industry Conference 2012: Latest Product Safety Directives of the Toys Industry: http://www.toyshk.org/news-01.php?page=1&cayear=2012&camonth=01&nid=79 Consumer Product Safety Commission: http://www.cpsc.gov/
Views: 223 HKTDC
Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. In this seven part slidecast we will demystify the process of bringing your device to market in the EU, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of October 2014. In this SlideCast: Overview of the CE Marking framework [4:40]
Views: 4774 Emergo by UL
Doorstep by Arūnas VINCIUNAS, Ambassador-at-large and Deputy Permanent Representative of Lithuania to the EU, on the outcome of the EU Tobacco Products Directive trilogue.
Views: 277 Council of the EU