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Let iCertifi help you with your CE approvals. Since we are a consulting firm, we offer a different approach to homologations.  Since we are not a test laboratory, we have partnerships with several test laboratories worldwide.  We will negotiate the pricing from multiple test labs to ensure you obtain the best pricing possible.  Since we are not tied to a single laboratory, we can also find laboratories with the best completion time. This allows you to obtain your certifications much faster which will allow your time to market to be expedited.

We have helped many companies become certified to sell their products in the European Union. Our experience in accordance with CE norms and our international partnerships with laboratories  and regulators allows you to engage a single company for all your International Market Access (IMA) needs.

Product manufacturers needed to display the CE mark(stamp) on their product. The process of getting a CE mark(stamp) may seem vague.  An outline of the process is as follows:

Distributors of products requiring CE marking should be inspected to ensure that this brand is present and properly positioned in the items. Distributors must also examine the accompanying documentation to ensure that the CE mark is obtained legally and correctly.

If you are a merchant for a product that is distributed in the European Economic Area, please contact us for professional certification services. We can help you to ensure that your products are on a legal level of safety, a level of health and environmental protection.

Postal stamps are established in accordance with the EC directives. This Directive is a legal act of the European Union (EU). The EU has established product codes for many industries in 1985. These standards are standards of health, safety and environmental protection.

Presently, set standards and legal standards are managed by two separate entities. While the European Union has established compliance with CE rules, you do not have to go through the EU. Instead, compliance can be applied in different ways.

1. Each distribution company has the opportunity to check the compliance efforts of their manufacturers. If the distributor checks their client’production, the manufacturer of the product must provide evidence of their CE mark.

iCertifi can assist you with  your CE certification which often is the first step in International Market Access.  If your ambitions are to sell your products globally, iCertifi can assist you with this process as well.  We are proficient in certifications such as; CE, FCC, Industry Canada (IC), safety type approval (CB Scheme, IRAM S-Mark), Energy Efficiency such as CONUEE in Mexico and more.  iCertifi can also provide you with local applicant services in any country you wish to penetrate.  Let us help you eliminate the burdens to International Market Access. Contact us at (541) 275-5020 to get started on your CE certification.

CE Certificate of Compliance allows products to move freely and sell on the European market. This brand offers consumers proof that the product meets the environment, health and safety standard set by the EEA. Performance requirements are not a guarantee of quality. This simply means that the product fulfills the conditions for sale in the EU.

It is important to note that the CE marking does not mean that the product is made in the EEA. The European conformity marking indicates that it has reviewed, approved and pass the environment, safety and health that the EEA has established for a product to be sold in the EEA.

It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.

Actually, it is similar to going to a builder, say that you want a six-room house on two acres, and asking to know the costs. That question is simply impossible to answer. There are far too many variables. It is the same with CE marking and CE certification. There are so many variables that can affect the price you pay. You don’t buy CE marking by the pound.

The price of CE certification can differ greatly from one product to another. I have seen prices range from $ 64 to $ 64,000. The price is often affected by which certification procedure applies to the product, whether the company can do some or all of the conformity assessments themselves, as well as the level of support needed to prepare the required compliance documents, Technical File, user manuals, and product labeling.

Which CE certification procedure or procedures applies/apply, is based on the technical specifications of a product, as well as its ‘intended purpose’. Only when these factors are clear, the correct CE marking directive or directives (yes, a product can be covered by more than one CE directive at the same time), European harmonized standards, and certification procedure can be determined.

In many cases, the CE directives offer two or more certification procedures that may be used. The costs associated with one or the other procedure can vary, and thus this is one of the aspects to keep in mind.

With this information, you can compare quotes from service providers such as test laboratories, certification bodies, and consultants and ensure that will provide the same service. (Compare apples to apples!)

This myth has cost a lot of companies a lot of money. In almost 90% of the cases, the CE marking regulations allow products to be self-certified for CE marking. In other words, you can do the CE marking yourself and you are not required to have the product certified by a third-party certification body. Obviously, CE marking self-certification can save your company a lot of time and money.

There are testing and certification bodies that are accredited for various international markings and certification schemes. With one basic test in combination with some targeted additional tests, your product can be approved for many markets, and thus you can spread the costs of certification over a bigger number of products.

I can give you a practical example: one of my clients manufactures a small optical inspection tool (a small car with a video camera) with an RF remote control module. The RF module was purchased from a vendor, and it already was CE approved. And as a result, my client did not have to test his product against the RF standards.

What I mean here are the costs of the persons who will have to dedicate time to the initial CE (self) certification, and afterward to keep updated with the regulations and standards.

As you can see there are many things to consider. All aspects mentioned above have an effect on the costs. In most cases, you can do a lot yourself, possibly with some guidance and instructions, thus saving a lot of money. Risk analysis, the compilation of the Technical File, conformity assessment against essential requirements of the directives and standards, and the Declaration of Conformity. These all can be done by you or your colleagues if you invest a little time in learning how to do it.

The biggest costs in CE certification are inherent to the time that test laboratories, certification bodies, and consultants need to spend on your products. I think that by looking at your product, you can already estimate that the time investment for conformity assessment, risk analysis, or the compilation alone is at least a full day of work, and likely more. Multiply this with a reasonable hourly fee, and you will conclude that the cost of CE certification easily exceeds $1500. For product testing alone you often need several days to run the required test procedure. I have seen wear and tear tests for construction products that take 1 month!

Surely, you may find laboratories and consultants in the market who claim they can do it for a very low fee. My experience and the experience of my clients with these companies is that the provided services are very cheap as well. Please consider this: the CE marking is about providing evidence that the product complies with the applicable requirements. In the case you have to involve a test laboratory or certification body, it is better to use a well-established, reputable company than a cheap unknown company. Because when your product’s CE compliance is challenged, its acceptance by authorities and your customers depend on the reliability of the (test)certificate and report.

At CEMARKING.NET, we have developed a Six Step CE Marking Framework that helps you to do as much as possible yourself, thus reducing the costs of CE marking. We offer this Framework as an On-Line Workshop, as a Coaching Program, and as a Done-For-You service. The first step is dedicated to determining which directives and standards apply to your products, and how you can do the CE marking efficiently and in a cost-effective way. For this, we conduct a documentation review and a gap analysis. We offer this first step of our framework as a separate service. That means you can get a report with an overview of the applicable requirements and recommendations with the steps you need to take, without investing in the full-service package. Contact us for more information on our services.

The EN standards were established as universal EU standards in order to facilitate EU directives. These standards were merged with the international IEC standards and henceforth reflect the standards in all countries. Also, the CE marking show that products conform to EC directives, and guarantee the free flow of products within the EC.

The EMC directive was 1 January 1996, and the low voltage directive was enacted from 1 January 1997. The telecom directive was established by the separate CTR (Common Technology References.)

With some exceptions, the directive covers mainly machine tools and injection mold equipment, automated machinery, construction equipment, and other industrial machinery,

Effectively, such equipment must neither be a source of EMI (electromagnetic interference), nor malfunction owing to extraneous EMS (electromagnetic susceptibility).

So, not only must equipment not emit electromagnetic waves that have a powerful external effect, it is also required to be immune to influence from extraneous electromagnetic waves.

This directive applies to all terminal equipment that is directly or indirectly connected to public lines and all communications equipment that sends or receives radio transmissions.

An abbreviation of Norme Europeenne (in French), and called European Standards in English. Approval is by vote among the CEN/CENELEC member countries conform to the international ISO/IEC standards.

Each EC directive stipulates, as one of the conditions for display of the CE mark, that the each factory producing the marked products has a proper policy regarding quality assurance.

The automation control products of Panasonic are manufactured in facilities that are verified to have excellent quality assurance systems based on compliance

The Department of Health, Division of Medical Quality Assurance, will now review your continuing education records in the electronic tracking system at the time of renewal. It will happen automatically when you renew your license, but it is important that you understand how this simple change will affect the way you renew your license in the future.

If the practitioner’s continuing education records are not complete, they will be prompted to enter their remaining continuing education hours before proceeding with their license renewal.

FREE “Just The Basics” Account –This account provides all the necessary tools for you to comply with the departments reporting requirements. You can view your basic course history, which will list the course name, educational provider name, date of completion and hours reported. It would then be up to you to determine whether all of the courses that have been reported will complete all of your specific continuing education requirements. You can also self-report any continuing education that may be missing.

Professional Account(Paid Subscription – Optional) – This account provides you with all of the tracking tools that CE Broker offers. Your transcript will display what your specific CE requirements are and will calculate what requirements have been met and what may still be outstanding. A Professional Account is a subscription service and is not a requirement but it can be a useful tool in managing your Florida continuing education requirements should you chose to subscribe.This account offers a 7 day Free Trial. This is NOT the FREE account.

Laurel Electronics, Inc.hereby certifies that all products that it has manufactured and/or resold since 2000 meet all directives to achieve CE marking. The CE marking (an acronym for the French "Conformité Européenne") certifies that these products meet EU health, safety, and environmental requirements to ensure user safety. Test results have verified compliance with the following:

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CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Blood Banking:CMP requirements will be revised to increase from 2 to 8 points in blood banking for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in chemistry for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in cytology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Gynecologic Cytology:CMP requirements will be revised to increase from 2 to 8 points in gynecological cytology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

CMP requirements will be revised to increase from 2 to 8 points in histology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Hematology:CMP requirements will be revised to increase from 2 to 8 points in hematology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Microbiology:CMP requirements will be revised to increase from 2 to 8 points in microbiology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Molecular Biology:CMP requirements will be revised to increase from 2 to 8 points in molecular biology for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

**NEW in 2024: Dedicated CMP Points in Cytogenetics:CMP requirements will be revised to increase from 2 to 8 points in cytogenetics for all certification cycles expiring in January 2024 and moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

CMP requirements will be revised to add 1 new CMP point in medical ethics (e.g., HIPAA, DEI (Diversity, Equity, Inclusion), sexual harassment/microaggressions, compliance, confidentiality, IRB, etc.) for all certification cycles expiring in January 2023 moving forward, regardless of when you submit your completed online declaration form. This does not increase the overall total CMP points required.

To ensure the integrity of the Credential Maintenance Program, the ASCP Board of Certification will review and audit a percentage of declaration forms each year.

CMP applicants who both (a) obtained medical laboratory education in, AND (b) currently reside in select nations will receive discounted pricing on their CMP application and (if applicable) reinstatement fees for all recertification of all ASCP international certification categories. CMP fees are non-refundable.

When an Athletic Trainer (AT) renews their national certification, it shows they value professional development, evidence based practice and are committed to the BOC mission of serving in public protection. We are your partner in promoting excellence in practice throughout your career.

The BOC sets the national standards for certification and through our list of BOC Approved Providers, we offer tools to maintain your continuing education (CE). CE requirements are intended to promote continued competence, development of current knowledge and skills and enhancement of professional skills and judgment. They must focus on increasing knowledge, skills and abilities related to the practice of athletic training. CE programs must also be intended for credentialed health care providers and wellness professionals.

ATs must complete a predetermined number of continuing education units (CEUs) during the certification maintenance period. The current period ends December 31, 2023.

All CE programs described for each category must be intended for an audience of credentialed health care and/or wellness providers (i.e., ATs, PTs, RNs, PAs, PTAs, MDs, CPTs) and the content must be at least entry level and pertain to the domains identified in the "Practice Analysis, 7th Edition."

Despite the trade deal between the UK and the EU being hailed as a major success for both sides, the main benefits of the agreement focus on the elimination of trading tariffs and the equalisation of customs rules. So far as the single market (and hence the rules for CE marking) are concerned, the UK is now split up into two parts: Northern Ireland remains within the single market while Great Britain (i.e. Scotland, Wales and England) leaves the single market and is free to set its own rules.

For most CE marked goods there will be a one year transition period commencing on 1 January 2021, during which time the CE marking will continue to be acceptable as an alternative to the UKCA mark for goods sold in Great Britain.

Products which require third party (i.e Notified Body) involvement as part of their CE marking process will have to use a UK Approved Body instead of (or as well as) an EU Notified Body - see below for more details.

Manufacturers based within Great Britain will need to identify a representative based within the EU whose name and address can go on the product as a contact point for the Market Surveillance Authorities.

TheUKCA mark is the replacement for CE marking in Great Britain. Applying the UKCA mark is exactly like using the CE logo. The Regulations and Directives which created the legal structure for CE marking have now been adopted into UK law and updated to change the terminology and to bring them completely within the control of the UK government.

To apply the UKCA mark, manufacturers have to do exactly the same things as they did to apply the CE mark, and in most cases they can use the same standards, risk assessments, test data, and technical files so the only thing which changes is the logo on the product and the words on the Declaration of Conformity.

Products being sold in the EU as well as Great Britian will continue to need the CE logo, so it"s likely that most products will have both the UKCA mark and the CE logo on them.

Those familiar with CE marking will know that the key to the process is the correct application of standards to provide detailed design guidance and recommended solutions for complying with the safety requirements of the CE Directives and Regulations.

Standards will continue to form the bedrock of the product safety landscape in the UK after Brexit. The UK Government will publish lists of "designated standards" which can be used as the basis of conformity with the UKCA requirements, in exactly the same way as harmonised standards provide a presumption of conformity for CE marking.

Standards will continue to be published in the UK by the British Standards Institute. BSI remains a member of CEN and CENELEC until at least the end of 2021, but only as an EEA member, not as a full EU member. This means BSI"s influence on the drafting of harmonised standards is diminshed.

It"s not currently clear what happens to the UK"s obligation to withdraw conflicting national standards and replace them with harmonised standards once BSI is no longer a full member of CEN or CENELEC. The obligation is part of the CEN/CENELEC agreement which national standards bodies must sign up to if they are to become full members and it"s probably the most significant factor in the harmonisation of products for sale across the single market. However, it"s difficult to see how the commitment to withdraw conflicting national standards is compatible with the full national sovereignty aspect of Brexit. The new UK-EU agreement includes words which indicate that the UK will focus on standardisation at an "international" level but quite what that means in practice remains to be seen.

Notified Bodies have an important role to play in the CE marking of many products. The Notified Body may be involved in type testing the design or in ensuring the consistency of production (quality control), or both. Where the Notified Body is involved in checking the conformity of production, their four figure number must accompany the CE logo on the product.

Notified Bodies must be located in an EU Member State, or in a territory where there is a mutual recognition agreement (MRA) between that territory"s government and the EU. There is (currently, at least) no such MRA between the UK and the EU, so all Notifed Bodies based in the UK ceased to be notified on 31 December 2020.

Most UK based Notified Bodies have now opened offices in European states and have had these appointed as EU Notified Bodies by the EU country where they are based so they can continue to provide Notified Body services in the CE marking field to their clients.

The UK Government has now appointed all the UK based Notified Bodies who requested transfer as UK Approved Bodies. They retain their four figure EU Notified Body number which must go on products alongside the UKCA mark if required by the relevant regulations for that type of product. Approved Bodies can only approve products which are UKCA marked and intended for sale within Great Britain, and EU Notified Bodies can only approve products for CE marking, so a manufacturer who wishes to sell both in the EU and in the UK must appoint both a UK Approved Body and an EU Notified Body. In practice, in most cases this can be the same organisation so long as it has a commercial presence and accreditiation in the UK as well as Europe.

The situation in Northern Ireland is even more complicated because the UK government has guaranteed equivalence between the Northern Irish market and the rest of the UK, even though the CE mark remains mandatory in Northern Ireland. Because a UK Approved Body cannot normally approve goods for CE marking, manufacturers based in Northern Ireland would need to engage the services of a Notifed Body from elsewhere in Europe. This would put manufacturers based in Northern Ireland at a disadvantage in comparison with their GB based competitors, so the Northern Ireland Protocol permits a manufacturer based in Northern Ireland to CE mark their products on the basis of certification from a UK Approved Body, but the CE mark on such products must be accompanied by a new logo - the "UKNI" marking. Products bearing the UKNI mark can be freely traded within the UK but they cannot be sold in the EU, despite them carrying the CE logo.

The following table summarises the situation, and our UKCA FAQ also has more information.Export of new products (CAB INVOLVED) placed on the market To

N.B. permanent UKCA mark on the product does not need to be attached until 1st Jan 2023. CE mark using EU Notified Body. CE mark using EU Notified Body. Local laws apply

The UK is no longer part of the EU and the transitional arrangements have expired. This means that any requirement in the CE marking legislation which mandates a presence within the EU can no longer be fulfilled by a UK based office.

Such requirements include the need to identify an Authorised Representative for medical devices, the requirement for an address within Europe for the "person authorised to compile the technical file" for machinery and the need to identify an EU importer for most of the other CE marking directives and regulations.

This means that manufacturers based outside the EU will need to come to an arrangement with someone who can fulfil this obligation from 1 January 2021. Furthermore, manufacturers based outside the UK who wish to sell products into the UK market will also need a representative within the UK. This is covered in much more detail on our Authorised Representative page, along with further information about new obligations under the Market Surveillance Regulation that come into force in July 2021.

Founded in 1894, Underwriters Laboratories Inc. is an independent, nonprofit organization with a rich history of promoting safe living and working environments with the application of safety science and hazard-based safety engineering. UL certifies, validates, tests, inspects, audits, advises, and trains its customers to navigate the growing complexities of regulatory compliance. One of the most common Safety Marks, UL has more than 1,400 safety standards against which it tests millions of products and their components every year.

UL is accredited by "Standards Council of Canada". The C-UL mark is accepted throughout Canada, and covers all UL’s facilities for testing and certification.

The CE mark, formerly the EC mark, is a mandatory conformity marking from the European Commission. The CE Listing Mark is mandatory on certain product groups such as medical devices, electronics, or toys sold since 1985 within the European Economic Area – EEA. It is a key indicator of a product’s compliance with European Union - EU legislation to meet health, safety, and environmental regulations, which ensure consumer and workplace safety. The European Commission describes the CE mark as an EU "passport," which fosters free circulation of products within the EEA.

Important Note: In July 2011, the Recast RoHS Directive was published in the Official Journal of the European Union. Therefore, as of July 2011, all products must meet RoHS Directive requirements in addition to other CE requirements in order to obtain the CE marking. However, as products exempt under RoHS may still receive the CE mark, CE compliance does not guarantee that a product contains minimal levels of hazardous substances.

In addition, the Recast RoHS Directive set in July 2011 included new categories, formally excluded from RoHS, to be added over time, with the eventual goal of including all electrical and electronic devices by 2019. New categories scheduled for inclusion under RoHS are as follows: Medical Devices, Monitoring and Control Instruments – July 2014. In-vitro Diagnostic Medical Devices July 2016. Industrial Monitoring and Control Instruments – July 2017. Active Implantable Medical Devices will be reviewed in 2020 for inclusion. All other electrical and electronic equipment not covered by any of the categories above – July 2019.

Adopted in February 2003 by the European Union, RoHS - Restriction of Hazardous Substances Directive 2002/95/EC, is a directive restricting the use of six hazardous materials found in electrical and electronic products. RoHS restricts the use of Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (Hex-Cr), Polybrominated biphenyls (PBB), and Polybrominated diphenyl ethers (PBDE). All applicable products in the EU market after July 1, 2006 must pass RoHS compliance.

In January of 2013 the RoHS 2 directive 2011/65/EU took effect. RoHS 2 is an evolution of the original directive, which addresses the same substances as the original directive, with more extensive regulatory conditions and greater legal clarity. RoHS 2 requires periodic reevaluations that facilitate gradual broadening of its requirements to cover additional electronic and electrical equipment, cables, and spare parts. Currently, any product sold with a valid CE mark must satisfy the RoHS 2 directive in addition to other CE requirements. However, the CE mark does not guarantee that the affixed product has minimal hazardous substances, as products exempt under RoHS 2 may display the CE mark.

Electrical Testing Laboratories - ETL has been conducting electrical performance and reliability tests since 1896 under Thomas Edison. In 1988, ETL was acquired by Inchcape, which in turn was bought out by Charterhouse Development Capital in 1996. The company was renamed Intertek Testing Services, forming the present-day Intertek, is a global leader in testing inspection and certification services. The ETL Listing Mark and C-ETL Listed Mark are accepted throughout the United States and Canada when denoting compliance with nationally recognized standards such as UL, ANSI, ASTM, NFPA, NOM, UL, and CSA. Intertek is an OSHA-recognized Nationally Recognized Testing Laboratory - NRTL and is accredited as a Testing Organization and Certification Body by the Standards Council of Canada.

The ETL Listing mark indicates that the product has been tested to meet the minimum requirements of a widely recognized product safety standard, that the manufacturing site has been audited, and that the applicant has agreed to a program of periodic factory follow-up inspections to verify continued conformance. An ETL Listing mark may include a small US and/or C, indicating that it follows product safety standards for the United States and/or Canada, respectively.

Since its initial charter in 1919, the Canadian Standards Association has grown into the largest standards development organization in Canada. The CSA works globally with other standards development organizations to harmonize international standards.

Its library of more than 3,000 standards and codes address subjects that affect the interests of business, industry, government, regulators, and consumers in Canada and the global marketplace. A Nationally Recognized Testing Laboratory, CSA is very familiar with U.S. requirements; according to the U.S. Department of Labor, Occupational Safety, and Health Administration – OSHA regulations, the CSA-US Mark qualifies as an alternative to the UL Mark. In addition, the CSA is accredited by the American National Standards Institute - ANSI.

Developed in 1992 by the Environmental Protection Agency and the Department of Energy, Energy Star - trademarked ENERGY STAR is an international standard for energy efficiency for consumer products that originate in the United States, Australia, Canada, Japan, New Zealand, Taiwan and the European Union. Devices carrying the Energy Star mark generally use 20 - 30% less energy than required by federal standards. In the United States, the Energy Star label is also shown on EnergyGuide appliance label of qualifying products.

The FCC mark, or FCC Declaration of Conformity marking, is a certification mark displayed on devices indicating certification by the Federal Communications Commission. It indicates compliance with FCC rules governing electromagnetic interference. These rules, located in 47 CFR 2.803 and 47 CFR 2.1204, require that most devices be authorized before they can legally be imported or sold in the United States. The FCC mark can be found on electronic products manufactured or sold in the 50 states, the District of Columbia, and U.S. possessions.