European Authorized Representative – I3CGLOBAL

 

Selling consumer electronics and telecommunications products in Europe is expected to be more difficult in the near future due to the updating of the EMC LVD and RED (R & TTE) directives in accordance with the New Legislative Framework within the first six months of 2016.

The new legislative framework aims to improve market surveillance and improve the quality of conformity assessments, it also clarifies the use of the CE marking and creates a set of tools to be used in product legislation.

As a result of the experience gained after the application of the, which in 2011 was initially updated in line with the New Legislative Framework, we can say that economic operators have clearly perceived the new measures determined in particular by the high increase in activities of surveillance and consequent penalties imposed due to a high percentage of non-compliance that was found.

The retail chains, being explicitly involved in the directives, have implemented a series of supplier evaluation procedures to select the producers and importers who are able to ensure the correct application of the European directives.

International manufacturers have certainly established technical offices in Europe to handle the requirements of the directives, while some other manufacturers do not have the economic convenience to do so as most importers / distributors are not familiar with the complicated CE marking problems. It means that the economic operators involved need more skills to manage directives efficiently.

A European Authorized Representative acts as a technical / legal body designated by a non-EU manufacturer and represents them in the EU and acts on their behalf in carrying out certain tasks required by the New Approach directives. An authorized representative is not involved in the distribution or sale of the products.

The designation of I3CGLOBAL as an authorized representative of the EU: offers the manufacturer a point of contact in Europe;

Save the cost of opening a technical office in Europe;

Makes it easy to enter the EU market: only one authorized European technical representative such as the I3CGLOBAL is needed in all European countries to deal exclusively with the regulatory issues related to CE marking, while the manufacturer may have many importers, distributors and representative’s sales in Europe.

It reaches the new EU market. Importers, distributors and sales representatives will be easier to buy and sell. They don't need to deal with complex compliance issues and product certifications that require in-depth professional skills;

I3CGLOBAL acts as a contact point for market surveillance authorities and end users in case of compliance issues;

I3CGLOBAL stores and updates the technical files of the products sold in Europe and makes them available only to the competent authorities upon request;

I3CGLOBAL monitors and reports on new developments in European product legislation relevant to customers;

I3CGLOBAL assists with product recalls and issuing advisory notices. Get in touch.

Declaration of conformity and CE / EU marking

 Most industrial products require a CE MARKING to be marketed in the European Union, regardless of their country of origin. The CE Marking or CE Certificate of Conformity should not be confused with the Declaration of Conformity.

 

The CE Certificate of Conformity or CE Marking is the result of making a product comply with all the technical requirements demanded by each of the applicable directives (documentation, tests, and implementation of quality systems in some cases).

 

The EU declaration of conformity is a mandatory document that the manufacturer, or his authorized representative, must sign to declare that his products meet the requirements of the European Authorized Representative. 

 

By signing the declaration of conformity, the manufacturer assumes full responsibility for the compliance of its product with the applicable EU legislation.

 

It is part of the technical documentation that must accompany every product upon entering the EU. This technical documentation provides information on the design, manufacture, and operation of a product, and must include all the data necessary to demonstrate that the product conforms to the applicable requirements, in this case, within the EU.

 

If we are manufacturers and we intend to introduce our product in the EU, or if we are businessmen established in the EU, recipients of products from outside the EU, there are certain rules that we must know, in relation to these issues. 

 

In particular, the manufacturer must, and in the same sense, the recipient of its products must also require:

 

• prepare technical documentation before placing the product on the market.
• ensure that technical documentation (if they request to see it) is made available to market surveillance authorities as soon as the product is placed on the market.
• keep the technical documentation for ten years from the date the product is placed on the market (unless expressly specified otherwise).

 

Know more about declaration of conformity and templates

UK Regulatory Consulting Services by I3CGLOBAL

 I3CGLOBAL UK supports strategic regulatory affairs activities with high added value to more procedural activities aimed at obtaining authorizations quickly and efficiently, guaranteeing both the quality and safety of medicines throughout their life cycle.

Our experience and versatility in regulatory affairs allow us to offer our customers a service tailored to the situation of each client, making it an easy way for commercialization of the product, saving time and money.

We offer our regulatory affairs services such as fda dmf 510k, European Authorized Representative Services, Medical Device CE Marking, Clinical Evaluation & Reports, UKCA Mark and more at the European level is centralized, decentralized, and mutual recognition procedures, coordinating regulatory activities with all the different member states and Drug Master File agencies supported by our knowledge of the specific requirements and procedures of the different countries of the European Union.

Also, we support foreign companies at the national level, as their local contact to help with all procedures and activities of regulatory affairs.

CLINICAL TRIALS

I3CGLOBAL UK Regulatory Affairs team has the experience and flexibility to provide a reliable and adapted service to our clients to act as a local contact in the UK, managing all regulatory activities to obtain authorization for clinical trials.

During the regulatory affairs phase, it is crucial to have experience and knowledge of bottlenecks to avoid delays in authorization that may have an impact on the development of the clinical trial.

For this reason, we coordinate operations for our clients between the promoter and hospital centers, researchers, ethics committees. Offering an efficient regulatory affairs service by delivery times.

WHAT IS THE CE DECLARATION OF CONFORMITY?

 The Declaration of Conformity is the written document through which the manufacturer or its representative in the European Union declares that the marketed product complies with the essential requirements of the European Directives that apply to it. 

 

I3CGLOBAL GROUP, advises you on the procedure of drafting the Declaration of Conformity of your product correctly to be able to market it without problems in the European Union.

 

The Product Declaration of Conformity is part of the necessary documentation to be delivered to the customer or end-user of the product. This document details the harmonized standards that have been applied so that the product complies with everything provided by European regulations. 

 

It is important in the Declaration of Conformity that the intended use of the product is detailed as it exempts the manufacturer from any accident that occurs with its product in use in another area.

 

A written document by which the manufacturer or his representative established in the European Union declares that the marketed product satisfies all the essential requirements of the different application Directives. 

 

The signature of this document authorizes the affixing of the "CE" marking when so indicated by the Directive.

 

Data to be included in the Declaration of Conformity for CE Marking (see ISO / EN 17050)

 

• Name and address of the manufacturer or its representative established in the European Union.
• Description of the product (sufficiently detailed so that it is easy to identify the specimens covered by it: brand, model, etc.).
• Relevant provisions to which the product conforms (New Approach Directives).
• Reference to the harmonized standards used (it is also possible to include other standards or technical specifications that have been used).
• Name of the Notified Bodies that have intervened in the conformity assessment of the product.
• "CE" type certificate number / s, if required.
• In the case of an importer or marketer, the name and business name of the latter.
• Identification of the signatory (name, surname, and position).

 

To know more about the EU Declaration of Conformity kindly visit i3cglobal.com website.

 

 

 

FDA Authorization for Medical Device Manufacturers

 Manufacturers and importers of medical devices established in the European Union are finding more and more possibilities of exporting these products to third countries. Currently, the American countries are the ones that are showing the most interest in medical devices marketed in the European Union.

Indian companies searching distribution, import, and manufacture of sanitary products are finding great business opportunities exporting their sanitary products with CE markingto countries such as Chile, Mexico, Argentina, Venezuela, or Colombia since the export procedures are accepted with the European CE marking.

They are reduced to obtaining a certificate of free sale for medical devices once the communication of the placing on the market of class IIa, Class IIb, and Class III medical devices.

These free sale certificates are issued by some Chambers of Commerce.

For the export of medical devices to the United States, it is mandatory to register the product with the FDA (Food and drug administration), for this it is necessary to provide documentation similar to that needed to prepare the Technical File that is prepared to obtain the CE marking.

Depending on the product (class I, II, and III) the FDA will require prior authorization for its marketing (PMA, premarket approval) for class III medical devices that have a higher risk associated with their use and simply a prior notification to the marketing Premarket Notification, 510k.

Once the appropriate process has been carried out and the authorization by the FDA (Acceptance Review) has been obtained, the manufacturer must mark the product with the FDA marking, which demonstrates that the product is safe and effective for its intended use and can be exported to the United Stateswithout the need for a certificate of free sale.

To know more about FDA Registration and other regulatory services. Kindly visit the www.i3cglobal.com website

Biocompatibility Testing of Medical Devices – I3CGLOBAL

 When materials such as PVC began to be used, exposure to phthalates was a constant concern due to its harmful effects on health. These are plasticizing substances necessary to make plastic soft, widely used in the manufacture of sexual toys. 

Therefore, the health authorities have found it necessary to regulate these materials, however, some Asian countries use substances with the same properties but which are not regulated. 

Currently, several alternative plasticizers are available for medical applications. These include TOTM, DEHT, DINCH, and BTHC, all approved by the European Authorized Representative for medical applications. 

These new plasticizers allow healthcare professionals and patients to benefit from PVC's unique properties, such as softness, without the use of phthalates of interest.

The ISO 10993-1: 2018 standard establishes a guide on how to evaluate the Biocompatibility testing, this standard constitutes the standard in tests of this nature. The first part of this standard is the test selection guide, the second part includes animal welfare requirements, and the following sections cover specific test processes and other test-related issues.

The biocompatibility of medical devices is investigated using analytical chemistry, in vitro, and animal tests. The biocompatibility of a device depends mainly on the following factors:

• The chemical and physical structure of the component materials.
• Types of patient tissue to expose to the device.
• Exposure time to this device.

The biocompatibility assessment of a medical device is done to ensure patient safety and is necessary whenever the device is in contact with tissue. When scheduling a biocompatibility test, manufacturers must consider their compliance goals and risks. 

Know more at I3CGLOBAL.com, Biocompatibility Testing Main Page

CE Marking Approval Process – I3CGLOBAL

 The CE Marking, which means European Conformity Mark, is represented by a specific graphic symbol (logotype) that guarantees the consumer the conformity of the product with all the provisions of the European Community which provide for its use from design, to manufacture, to placing. on the market, from commissioning of the product to disposal.

This symbol was created in 1993 and, on many products, it is mandatory to be marketed within the European Economic Area (EEA) which includes the countries of the European Union and the 3 EFTA countries (Norway, Iceland, and Lichtenstein).

Therefore, a product that is marketed in Europe must have the CE mark whether it is manufactured in China or whether it is manufactured in a country of the European Union such as the USA.

TU: Does this apply to all products?

No, not all products on the market are required to have European Conformity. Here are some examples.

• Products that must have European Conformity.

Toys, medical devices, electrical devices, sunglasses, eyeglasses, gas devices, cars, radios and TVs, vertical road signs, etc. In these products, the trademark is mandatory, because they expose the buyer to very serious risks during use.

• Products where the CE mark is not mandatory

Wooden furniture, armored doors, fixtures, gardening items, clocks, non-electric musical instruments, mattresses, scissors, cutlery, plates and glasses, footwear, luggage.

Counterfeiting of the CE mark

Like other brands, the European Conformity brand is also exposed to the risk of counterfeiting. One of the best known is that of the CE - China Export mark.

The graphic designs of these brands differ very little, leading the consumer to confuse them in 90% of cases.

The sanctions are very severe, both from a civil and criminal point of view.

Manufacturers who use the counterfeit CE mark for their product incur penalties such as:

• Payment of a fine from 1,000 to 6,000 euros
• Criminal proceedingsfor any damage suffered (which can be requested up to 5 years later)
• Void purchase-sale relationship(it is possible not to proceed with the payment or to return the goods without conditions )

How can I get this mark on my product?

To be able to affix the CE Mark on your product you must first have an EC Certificate as proof of passing the tests (tests, inspections, etc.) required by the directive to achieve the CE marking.

This Certificate is based on a self-declaration by the manufacturer in which he affirms that he complies with all the requirements established by law (Decision 93/465 / EEC of the Council of the European Union, of 22 July 1993) to obtain the mark itself and assumes its full responsibility.

Here, in detail, are all the steps to use the CE mark on your product.

• Specific tests.

These are tests and technical tests to be performed on the product to verify its safety and compliance with European standards.

• Technical File.

Secondly, the manufacturer must prepare a technical file to be made available to the authorities, in which he collects all the documents proving the conformity of the product with the technical requirements.

Attention: in some cases, this "self-certification" must be evaluated as "Notified Bodies" which must verify if the product meets the specific technical requirements.

• EU Declaration of Conformity.

Finally, it is necessary to draw up and sign an EU declaration of conformity that certifies the conformity of the product to all legal requirements.

Only at this point, the manufacturer will be able to affix the CE mark on the product and on the packaging, to be able to market it in the European Economic Area, without the Member States being able in any way to restrict its circulation.

The CE mark is completely different from the European mark which instead protects the name of a product or service.

If you want to know more, contact the I3CGLOBAL TEAM by writing to enquiry@i3cglobal.com. We help you understand all the steps to take to obtain a European trademark and to protect your product.

You can delegate the legal part to industry experts who have been dealing with trademarks, patents, and copyright for over 10 years.

Book your free appointment now by writing an email to enquiry@i3cglobal.com or visit the CE Marking Approval page for more information