What is a predicate device?

 A predicate device is an existing previously cleared 510k Certification  and is marketed under a regulatory pathway that is used for the  comparison between the proposed device to prove the substantial  equivalent.

Multiple  predicates can also be used for comparing the substantial equivalence  when the proposed device has more than one intended use, but it is  better to compare the substantial equivalent with one single predicate  device.

Predicate devices are selected based on

• It should have a similar product code, regulation number, and intended use as same as the newlyproposed device.
• It should have the same technical characteristics as the proposed device.
• It should have the same design and material as the newly proposed device.
• It should have the same safety and effectiveness as the newly proposed device.

Predicate device identifications are verified when stating substantial equivalence and if the FDA 510k submission is provided with an incorrect predicate device, then FDA holds or withdraws the submission.

substantial equivalent

It  means when the proposed device is the same as the predicate device and  is safe and efficient for the user. Which has the same device intended  use and similar technological characteristics.

Technological characteristics – performance testing, clinical testing, an additional requirement.

The device is said to be substantially equivalent if it has:

• Same intended use and same technological characteristics as legally marketed device

Or

• Have different characteristics but it does not raise any questions about its safety and effectiveness

 

Decision making of substantial equivalence for a 510K

• Identify predicate device for the newly proposed device
• Compare both the device
• Check if both the device has similar intended use and characteristics
• If both are similar, then it is substantially equivalent

                  Or

• If it has different technological characteristics, then sufficient testing is required
• Check if the data taken from testing passes the acceptance criteria
• If both are similar, then it is substantially equivalence

 

Difference between substantial equivalence and predicate device

PREDICATE DEVICE	SUBSTANTIAL EQUIVALENCE
It is a legally marketed device	It is a method to find the SE of the proposed device
It is used to find if the newly proposed device is safe and effective by comparing with the predicate device.	Comparison method between predicate device and proposed device to find the substantial equivalence.

 

EU REPRESENTATIVE FOR MEDICAL DEVICES

 Why should you work with I3CGLOBAL as your European Authorized Representative?

I3CGLOBAL is one of the world's largest regulatory consulting firms, assisting small and medium-sized businesses all over the world.

Our knowledgeable advisors will analyze your Technical File, register your medical device or IVD, and reply to any queries or issues raised by the Competent Authorities.

We take great care in managing and maintaining your technical documents. Our extensive knowledge of European legislation, gained through the registration of hundreds of devices, ensures a simple and quick registration procedure.

We give out periodic updates to all of our Authorized Representation clients on key regulatory developments in Europe.The Regulations on Medical Devices (Regulation (EU) 2017/745) and In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) altered the European legal framework for medical devices, introducing new responsibilities for the EMA and national competent authorities in the evaluation of certain categories of medical device.

 

Contact I3CGLOBAL 

I3CGLOBAL will assist with all reporting, registration, and contact with European authorities and organizations to the right person at the right time, every time. The European Authorized Representative must also keep a copy of the manufacturer's Declaration of Conformity and Technical File, as well as a record of product complaints in Europe, according to the Regulations.

• Germany+ 49 2161 990 8831
• Bangalore +91 99 4591 2081
• Mail to: enquiry@i3cglobal.com

Visit Us:- CE Marking for Medical Devices

Aspects to consider when registering in the health registry

 Keep in mind that the activity of your business will determine whether or not you should apply to be included in the registry. FDA Registration India, you will have the responsibility to keep the health organizations up to date regarding any alteration in the physical address of your establishment or changes in ownership.

You must also notify the variations in the characteristics of your facilities or production systems, as well as the cessation of the activity of certain production lines (if applicable)

Depending on the characteristics of your establishment, there are various forms of registration in the health registry. Among these are:

–  Registration of products of animal origin: once the respective documentation is delivered, an inspector will verify that both the facilities and the processes comply with the defined protocols before the establishment can start its activity.

–  Registration of products of non-animal origin: by requesting the responsible declaration, the business may start its production even if it has not received the visit of the inspector. Then, if modifications are presented, they must be considered to continue operations.

–  Direct sale to the consumer: retailers (restaurants, bakeries, butchers, supermarkets, hotels, hospitals…) will also be able to start their activities by making a responsible declaration. Then, they will receive a visit from the health authority.

Benefits of enrolling in the health registry

Sanitary registration is a document that provides extensive benefits to companies. For example, it allows them to market their food products in all the member states of the European Union, and it is public, therefore, any of your clients can check the I3CGLOBAL website to corroborate the information.

In addition, it is important to avoid unexpected visits that could threaten the definitive closure of the establishment by not having this mandatory procedure.

Obtaining the sanitary registration is a necessary step so that your food company can carry out its production legally.

If you do not have the necessary requirements to obtain the sanitary registration or you need advice on food safety and how to carry out this procedure, it is best that you contact us so that we can help you and thus you can start the operations of your company in the shortest time possible in order to avoid serious penalties for a health inspection.

Read More:- FDA Registration India

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.