What Should You Know About The Medical Devices?

Every month, there are a lot of new medical devices which are submitted for the marketing approval from the FDA. One of them is the Medical Device CE Marking which shows out the one device which will show the audience that it is purely legal and it is authorized for being a medical device. Most of these devices are firstly turned down or they are also re classified some of the times, but hundreds and thousands of them ended up in getting the approval for marketing it nationwide. You should also do the Medical Device Consultants for which there are also several types of companies that are available for the approval. It makes sure that the device is totally risk free. Companies also work on their IVDR Technical Documentation so that they can show the FDA to pass or authorize their devices.

You can always seek from the FDA, that which rules are going on some of them are PMA, HDE and 510 K. There is also the FDA certificate which we will review for each and every type of the approval in this particular article and will also provide you some of the few examples for the devices that are approved. You can also show the UDI Medical Devices in its packaging so that the people can understand it easily and then make use of it. Nowadays people always like to do such things which are easy to choose and handle. Manufacturers and also the supply companies need to get their items re approved each of the time a particular change is made, such as the different type of electronic boards, lubricants, or when the software is changed. These re-approvals which happens seems to make up all the majority of applications for the approval, but there are now also many of the new devices and companies which are still striving for improving the medical devices and it’s equipments worldwide.

As you can see that nowadays people are going on severely from corona or also known as covid-19 so you should make the necessary precautions for it so that you can prevent that from happening to you. So the best way by which you can make a good precaution is by wearing a face mask. Face mask 510k also happens to test out the quality of it and how durable it is. Now after it you can see that doctors also need the mask so they wear a surgical mask while doing something in the hospital so they also have the Surgical face mask 510k for the quality issues and all of that, so that it can come into the official list of medical things, and same is the story with the Surgical gown 510k, it also happens every time. The FDA Registration is as important as owning a face mask because it makes sure that you get a quality product and which is authorized by the FDA.

Systems and Procedure Packs is also one of the important things while getting your medical product authorized, so do everything properly and get the best medical devices in the market.

Important Information About The Medical Devices

 Medical devices make up a huge and complex field in this world. There are a lot of devices which ranges from anything between a pacemaker and a thermometer. In these products they also come with some particular markings such as CE marking for medical devices and the FDA 510 K and also the NIOSH Certification etc. so firstly we would be talking about the medical devices CE marking which shows that the particular device which will meet the legal requirement for the major medical devices. If you want to place a CE mark on some certain medical device. The FDA, the US food and the drug regulatory body, has made a definition for all the devices. It always considers a particular medical device as an instrument, machine, apparatus, contrivance, implant, or the other similar related things

There are also some of the FDA 510k Consultants which has the lunar role for regulating all the medical devices in the industry. It is the one of the best software CE marking for all the medical devices, a role which has assumed all the considering to the serious health implications that are even for a smaller fault in a device which can cause something.

There is also some particular medical device classification of the medical devices such as:

1. Class 1 medical device.

2.Class 2 medical device.

3. Class III Medical Device.

What do you mean by FDA approval?

An FDA approval is for the medical devices which mean that the particular product is always ready and certified as it is ready for the marketing. Everytype of manufacturer has to get the FDA approval for their marketing advice. It has to always get this clearance through the premarket notification or what is being called as the FDA 510 K. The FDA will clear out the device which has been sent to the approval, or even reject it. If the device will meet the stringent criteria which is set by the FDA for the approval, then it is always considered as approved.

Is the 510(K) important for all the medical devices?

The answer is a big no. Not all the devices are in a need of going through the 510(K) process. Devices which are classified under, means that those devices which pose the least risk for the user don’t need a 510 (K). Only a few of the Class II and most of the Class III devices, which entails a higher risk for the user, are subjected to the510 (K) premarket approvals.

There is also some of the European authorized representative which helps the people by serving them as the legal entity which is designated by the non European Union manufacturers. The EU representative is the particular person which is designated, where it is applicable, to represent the companies which are not based in the Europe regarding the obligations that they have under the GDPR. Therefore it is the best thing that you can get.

The US FDA Consultants are also good at the Biocompatibility testing which can help you in a lot of ways by getting your device tested and approved.

Medical devices - Class III: General Controls and Premarket Approval

A Class III device needs to go through premarket approval (PMA) by the FDA before it can be marketed for use. Class III devices are usually invasive, life-sustaining, life-supporting, or is used “in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury”.

In order to CE mark Class III devices the following requirements should be met to this end:

• Technical File for each family of devices should be prepared. This file should contain legal information, documentation, manufacturing process and performance of the product to show its effectiveness and safety. It includes the product Risk Analysis according to the EN 14971 harmonized European Standard, material safety data sheets, biocompatibility of materials, hygiene and sterility tests, manufacturing processes control procedures, operation manual/instructions, and any relevant documentation, as required by Exhibit I “Essential Requirements” of MDD, including clinical and medical support information. According to the type of device, some of these requirements may not apply.

• The Manufacturer must implement a Medical Quality Management System that will comply with the requirements of the MDD 93/42/EEC directive. The best, it to adopt a harmonized standard such as ISO 13485:2003 which s now the gold QMS standard in this Industry. In addition, we recommend, for commercial reasons, that this system should meet ISO 9001:2000, but ISO 9001:2000 alone does not comply with the requirements of the medical equipment directives. For more information, see CE QMS Requirements.

• Choose Conformity Assessment Route: refer the flow chart below.

• Declaration of Conformity.

• Ensure the device is a Class II medical device.

• Vigilance and Post Market Surveillance. (affix ce marking approval & market the products)

The conformity assessment routes for Class III Medical Devices

 

In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

1. follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
2. follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) The procedure relating to the EC verification set out in Annex IV; or

(ii) The procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).

Class III controls are similar to those for Class IIb devices but additionally require the manufacturer to submit the design dossier to the Notified Body for approval under Annex II and do not allow the Annex III/Annex VI option.

There are two routes:

1. Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003), plus that the manufacturer must submit the design dossier to the Notified Body for approval under Annex II, or
2. Type-examination (Annex III) plus one of the two options given here:
   • Examination and testing of each product or homogenous batch of products (Annex IV); or
   • Audit of the production quality assurance system (Annex V  ISO 13485:2003 (excluding Design)

Once the manufacturer has received certification from the Notified Body he may CE mark his products and place them on the market.

Medical Device Classification

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.

A medical device (MD) may be classified as Class 1**(including Is & Im), IIa**, IIb** and III**, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body Medical Device Classification .

The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules. Classification of a medical device will depend up on a series of factors, including:

• how long the device is intended to be in continuous use
• whether or not the device is invasive or surgically invasive,
• whether the device is implantable or active
• whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.

The authorization of medical devices is guaranteed by a Declaration of Conformity. (FAQ)This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. (FAQ) Medical devices that pertain to class I (on condition they do not need to be sterilized or are not used to measure a function) can be put on the market purely by self-certification.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc. These packaging should also show harmonized pictograms and EN standardized logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don’t reuse, etc.

Technical Documentation

The Technical Documentation must prove that the product fulfils the requirements laid down in the Medical Devices Directive 93/42/EEC. The Technical File for medical devices should take account of the following aspects:

 

• Table of Contents with revision status and proof of completeness of the file

• Name and address of the manufacturer  and/or if necessary: name of the European representative also and all places of manufacturing, excerpt from the commercial register or a registration of a business

• Description of product family including all variations planned and the Intended Use

• Declaration of Conformity

• Proof of fulfillment of the Essential Requirements  according to Annex I

• Product classification

• Risk analysis in accordance with EN ISO 14971:2007

• List of the applied standards

• Information for use (e.g. Instructions for Use, Technical description)

• Product identification (e.g. labels, warnings, used symbols)

• Description of Packaging and Labeling

• If applicable, design and production drawings as well as plans of mechanical components and devices ect. (mechanical drawings) and  Electrical Circuits (Block Diagram)

• If applicable, results of design calculations and performed testing

• If applicable, used method and validation report of sterilization Biocompatibility

• If applicable, test reports of electromagnetic compatibility (EN 60601-1-2:2007)

• Clinical evaluation according to Annex X, MDD

 

Simply speak to us – we look forward to hearing from you!

As a manufacturer, you may only market medical devices in the European market if all the requirements of the relevant Directive have been complied with. As one of the few Notified Bodies for all the Directives listed on the left, we help you carry out your conformity assessment procedure for CE marking as well as assist you to acquire worldwide approval of your medical devices.

 

• Definition of the medical device/intended use

As a manufacturer, you determine the intended use of your device. This results in a decision as to which directive is applicable to your medical device (MDD, AIMD or IVDD).

 

• Classification of the medical device

In the MDD, the medical device is classified in accordance with the regulations in Annex IX. The AIMD does not provide for any classification. The IVDD distinguishes between products for self-testing, for performance evaluation, Lists A and B and products which do not fall into any of the categories named.

 

• Determining the suitable procedure for conformity assessment

Depending on the classification of the product, a Notified Body is required which, for example, you will entrust with carrying out an EC type-examination, with assessing a design dossier and/or with auditing your QM system. AIMD products always require the involvement of a Notified Body.

 

• Technical documentation

The manufacturer must prepare a technical documentation for every type of medical device, which essentially consists of the following documentation on the product:

 

Description of the device, design documents, the standards to be applied and a description of the solutions chosen to meet the essential requirements, risk analysis, test reports, clinical data, labelling and instructions for use, and additionally for sterile devices descriptions of the sterilization procedures used and the validation certificates.

 

Medical devices must meet the applicable essential requirements listed in Annex I of the respective directive. With the help of the conformity assessment procedure, proof must be provided that the safety requirements have been met and that the technical services have been rendered. The medical effectiveness must be proven through a clinical assessment. The manufacturer is free to choose how he will provide the proof that the essential requirements have been met.

 

As a test body for medical devices, we can carry out various tests for you, such as safety, functional and biocompatibility tests. We perform them either in our own laboratories or in contract laboratories. You can use the resulting test reports as an acknowledged proof for your MDR technical file .

 

• EC type-examination or examination of the design of the product

For all AIMD, MDD Class III and IVDD List A products, the manufacturer must decide between the EC type-examination procedure and the examination of the product design documentation (design dossier). In this process, we -as your Notified Body-  either test the product including the product documentation or the design dossier. After successful examination, our certification body issues an approval in accordance with the directive.

 

• Implementing the conformity assessment procedure

Usually, the manufacturers of medical devices choose the procedure of auditing their quality management system. The auditors assess the documentation of the QM system prior to the audit and verify the application of the written procedures during the audit at the company. The duration of the audit and the number of auditors depend on the size of the company and the variety and kinds of products and are specified in an individual quotation. After the audit, you will receive a written report with the audit results.

 

As an alternative to the audit, the EC verification procedure (sampling or individual testing) in accordance with Annex IV (MDD) or Annex VI (IVDD) can be applied. If the conformity assessment procedure has been completed successfully, our certification body will issue an approval for the CE marking of your devices.

 

Simply speak to us – we look forward to hearing from you!

 

Conformity Assessment Procedure

Handling processes can be speeded up. A first step is our following sequence plan (for medical devices in accordance with the AIMD, MDD, IVDD directives):

 

• Establishing contact

First, we present ourselves and our range of services and get to know you, your company and your products. We then determine further procedures together. Early establishing of communication, e.g. as early as in the product development phase, allows for better coordination of the time schedule for the market launch of your product.

 

• Quotation

We will then prepare a quotation for you covering the services you request on the way to acquiring CE marking (QM audit according to EN ISO 13485 and EN ISO 9001, product testing, examination of the technical documentation, etc.).

 

• Order

After receipt of the order, we will discuss any open questions and coordinate the project handling together with you.

 

• Technical documentation

Prior to the audit, selected documents out of the technical documentation will be checked for plausibility and for conformity with the requirements of the directive.

 

• For all AIMD, MDD Class III and IVDD List A products

Examination of the design dossier or EC type-examination. You submit to us the documentation on the product design (design dossier), and we will check it for completeness and plausibility. Or we test your product and the associated documentation. We will then issue a report on the test results. If the assessment is positive, you will receive the following certificates:

 

• MDD: Annex II.4 or Annex III

• AIMD: Annex 2.4

• IVDD: Annex II.4 List A or Annex V

• Voluntary pre audit

We will base the scope of the pre audit on your wishes. You will receive an audit report in which potential for improvements will be pointed out.

 

• Review of the QM documentation

The QM documents, such as the Quality Manual as well as relevant procedures, will be assessed by us prior to the audit, and you will receive a report on our findings.

 

• Certification audit

Prior to the audit, you will receive an audit plan agreed on with you. During the audit, the operations in your company will be examined and thus the implementation and effectiveness of the requirements of the applicable directive and the relevant standards. In the process, we will particularly assess the conformity of the products with the essential requirements. The team of auditors always includes at least one expert on your product range. All relevant production sites are included in the scope of the audit. You will receive a detailed report on the performed audit that includes also advice for improvement.

 

• Certificate/approval

If the audit result is positive, you will receive an approval for the selected conformity assessment procedure.

 

• MDD: Annex II.3 or Annex V

• AIMD: Annex 2 or 5

• IVDD: Annex IV.3 or VII.3

 

In addition, certificates according to QM standards EN ISO 13485 and where required EN ISO 9001 are issued. Afterwards, we will carry out surveillance audits every twelve months and a recertification audit after five years.

 

• Declaration of Conformity

You are now permitted to issue the declaration of conformity for your medical devices, to provide them with the CE marking including the identification number of the “Notified Body” and to place them on the European market.

 

Contact us – we are looking forward to hearing from you!

FDA 510(k)Consulting

I3CGlobal is the ONLY consulting company who takes up complete turnkey FDA 510(k) projects. We cover any type of medical devices anywhere in the world FDA 510k .

Special features of I3CGlobal

• We will not assist, we prepare 510k!!!
• We provide service of US Agent!!!
• Initial in-depth study of product and regulatory followed by overall guidance
• Development of a Project Plan and confirmation of the specific deliverables.
• Guidance on testing
• Communicate to FDA regarding review comments
• Support in implementing 21 CFR 820
• Establishment registration
• Listing of products with US FDA
• Payment after completing every phase.

Any clarification and service request please fill up the enquiry form

Classification of medical devices

The United States Food and Drug Administration (FDA) oversee European Authorized Representative (Non European) medical device companies that must comply with the Center for Radiological Devices and Health (CDRH) while selling medical devices in the US market. The FDA regulates EU representative (Non european country) medical device products and companies that manufacture, repackage, relabel or import medical devices sold in the United States.

The FDA classifies the medical device into the following classes: Class I, II and III with regulatory controls increasing from Class 1 medical device to class 3 medical device. The FDA classification for Medical Device Classification according to the specific requirements for each device is as follows:

-Class I devices are exempt from pre-market notification.

-Class II devices require 510 (k) premarket notification

-Class III devices require premarket approval (PMA)

US FDA Consultants can assist you with the classification of a potentially marketable medical device using FDA guidelines. Compressing FDA rules and regulations regarding the three different classes can be complex, but necessary to determine the future of a device.

The attorneys at the US FDA Consultants advise and represent medical device companies on marketing requirements including:

FDA regulations on labeling of medical devices

FDA Medical Device Registration (India)

Registration of medical device installation with the FDA

FDA advertising and marketing regulations for medical devices

Withdrawals of medical devices

FDA Inspections and Corrective Action Plans

Represent FDA medical device companies against the FTC and NAD

Compliance in import and export

Preparation and presentation of the 510K pre-market notification of medical devices

Quality System Regulation

Medical Device Reporting (MDR)

Biocompatibility testing

If you are searching the market for a new medical device, introducing an existing medical device to the US market that is currently marketed in a foreign jurisdiction, you have received a warning letter from the FDA, or any other FDA compliance issue, Contact US FDA Consultants for a consultation and to discuss the future of your medical device within the US market and for FDA Certificate (India).

FDA Registration (India) purposes, medical devices are classified according to the degree of risk they represent, which is evaluated according to the time of contact with the human body, the degree of invasiveness, if it releases drugs for the patient, if it is used in combination with other medication or device.

In US, they are grouped into three classes, where Class I corresponds to those devices with the lowest risk for the organism, those inputs whose safety and efficacy are fully evaluated, are generally devices that are not introduced into the human body.

Class II: Represents those inputs that may have variations in their elaboration or concentration, are introduced to the human body for a period of less than 30 days.

Class III: Those inputs that are introduced into the body, and that remain in the body for periods longer than 30 days. It is worth mentioning that the latter devices have increased their production due to technological medical advancement, as the companies that distribute them have innovated in such a way that their position in America has increased along with scientific advances and new technologies of developing. An example of this are those mono-implants that seek to regulate the functioning of internal human organs.