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

FDA Registration

 A drug broadly speaking, is any substance that when administered into the body either Internal or external for treatment, mitigation or prevention of any disease or disorder in a living organism which can alters normal bodily function.

There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.

Cosmetics are substances used to enhance the appearance of the human body. Cosmetics can be rubbed, poured, sprinkled or sprayed on, or introduced into the human body or any part thereof for the above said purpose, and includes any article intended for use as a component of cosmetic.

United States Federal Food, Drug, and Cosmetic Act, as per section FDA 510 K requires manufacturers, Repacker, and relabels that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products must register their establishment(s) and submit a listing of every product in commercial distribution.

Drug establishment registration and drug listing done online by US Agent. From 1^st of June 2009 onwards FDA not accepting paper submissions for drug registration and drug Listing. Electronic system which will improve the timeliness and accuracy of the submissions.

I3CGLOBAL provides following FDA Drug establishment Registration and listing related service. Drug establishment registration, Labeller code, DUNS processing, US Agent, Drug Listing, Label Review (optional), In SPL format (preparation and submission)

Medical Analysis Record

Today we'll cover a few of the more crucial facets of professional analysis reports.

The professional analysis report, likewise referred to as a CER, is examining as well as analyzing scientific data concerning a clinical gadget. A professional proof report is required for all categories tools and also consists of a mix of direct and also indirect medical data.

This is normally a combination of medical tests, clinical examinations, released clinical documents, as well as post-market data from both publicly offered resources as well as the producer.

Our Clinical Analysis report's main purpose of a CER is to show a beneficial risk-benefit profile of the medical tool. It sustains the medical security and efficacy of the medical tool. It ultimately is used to show conformity with the appropriate general safety and security and also efficiency demands in Europe and also the main principles in Australia.

To offer a bit of added context for this discussion, we intended to offer a little a review of the territory or demands as well as guidance with the scientific proof reports.

In Europe, the demands and needs for scientific evidence reports are dictated by the medical tool guidelines referred to as the MDR. This resulted from enter result in Might of this year but has actually lately been delayed because of the pandemic and is currently expected to affect Might of 2021.

It is very important to note that the MDR additionally has a need around a professional evaluation report plan to be detailed as well as followed along with the medical examination report.

The most up to date modification of the medical proof record advice document referred to as the med dev 2.7/ 1 ref supplies detailed direction on the layout as well as the call content of this professional evidence record.

Well, there are some differences between Europe and also Australia. They remain compatible, such that our manufacturers can produce a solitary medical examination report to cover both Australian and European policies.

In the United States, while a formalized clinical proof record is not specified within the USA FDA demands, the data is still important in demonstrating that the tool is risk-free and efficacious for its desired purpose, which is a requirement of the FDA guidelines.

The content and also purpose of the CER have significance throughout all jurisdictions. A clinical evaluation record consists of demands for evaluation and afterwards assessed for both direct and also indirect professional information.

To recognize more concerning CER, Kindly visit our site http://www.i3cglobal.com

Read More :- Medical Device Usability

What is FDA 510k?

An FDA 510k is a pre-marketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective that is substantially equivalent to a legally sold device that is not subject to premarket approval PMA

510 k premarket notification to FDA is required at least 90 days before marketing unless the device is exempt from 510 k requirements.

Here are the 510k four phases below.

1. Know your product code.

If you do not know your product code, click on the product code list, and get your product code.

2. Once you know your product code, you need to understand how your medical device is classified and your product's 510 k requirements.

Does your device require 510k Submission to FDA, or as your device exempt from 510 k submission?

We made it simple and easy for you. Enter the product code and check your device class regulation and 510 k requirements.

3. If your device required 510 k premarket notification to FDA, get your product 510 k total product lifecycle reports.
4. Take a look at the sample reports.

The sample reports give you valuable information regarding your product device class device regulation details, review panel details, GMP exempt details, all manufacturers and their device submission related to the product code, and FDA decision letter 510 K.

The FDA decision letter contains predicate device details device description, intended use, and substantially equivalent comparison.

Now you have all the required information. Prepare 510k Submission

If you want to learn more about the FDA 510k submission process, visit our website page. 510k Submission and guidance.

Thank you for reading.