By affixing the CE Marking, the manufacturer, or its representative, or the importer assures that the item meets all the essential requirements of all applicable EU directives. Neozenith offers conformity assistance with Construction Products, Containers, Cranes, Electrical Products and Components, Electromagnetic Compatibility (EMC), Lifts, Marine Equipment, Materials, Mechanical Products, Process Machines, Pressure equipment, Personal Protective Equipment (PPE), Telecom, Toys and Wood. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, etc…can further reduce timescales and costs.
The CE Marking Process has six simple, but necessary steps to complete to enable you to CE Mark your product.
STEP 1: IDENTIFY THE APPLICABLE DIRECTIVE(S)
The first step is to identify whether your product can be CE-marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 product Directives & Regulations covering a range of products. Such products include (but are not limited to) electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices, and construction products.
STEP 2: IDENTIFY THE APPLICABLE REQUIREMENTS OF THE DIRECTIVE(S)
Each Directive has slightly different methods of demonstrating conformity. This usually depends on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ which the product has to meet.
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of applicable ‘harmonized European Norms’ (Standard) known as hENs. Standards may offer a presumption of conformity to the essential requirements of the applicable Legislation. However, do not forget that the use of standards usually remains voluntary. hENs can be identified by searching the ‘official journal’ on the European Commission’s website.
STEP 3: IDENTIFY AN APPROPRIATE ROUTE TO CONFORMITY
The CE Marking process is always a self-declaration process however you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directive. Some products (such as invasive medical devices or fire alarm systems) may, to some extent, have a mandatory requirement for some involvement of an authorized third party.
STEP 4: ASSESSMENT OF THE PRODUCT’S CONFORMITY
When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s).
This usually involves some assessment and/or testing. It will often involve ensuring that the requirements of the applicable harmonized standard(s), which were identified in Step 2, have been met.
STEP 5: COMPILE THE TECHNICAL DOCUMENTATION
Technical documentation relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development, and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.
Technical documentation can be made available in any format (i.e., paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).
STEP 6: MAKE A DECLARATION AND AFFIX THE CE MARK
When the manufacturer, importer, or authorized representative is satisfied that their product conforms to the applicable CE Marking Directives, they must complete a Declaration. Under most Directives, it is known as the EU Declaration of Conformity but other terms exist. Such as a Declaration of Incorporation for partly completed machinery and a Declaration of Performance for construction products.
Key Benefits of CE Marking Certification
Access the world’s second-largest importer (and largest exporter)
It is mandatory to understand your obligations and demonstrate compliance
Working with a Compliance Provider from project concept helps reduce project life cycle timescales and budget
Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, ROHS, etc…can further reduce timescales and costs
Our Approach of CE Marking
One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage. At Neozenith, we can assist with the entire life cycle of a product from design and development, supply and production, distribution and delivery, to retail distribution and even final dismantling or destruction.
Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, and what are your quality expectations?
The responses help us to identify the regulatory barriers, the directives, the standards, your conformity assessment route option, etc. And to develop a rationalised compliance plan for your product range with your target markets within, as well as outside, the EU.
CE Marking for Medical Devices:
Devices that are intended to be used for medical purposes are likely to be required to be CE marked under the Medical Devices Directive (93/42/EEC, as amended), however it is important to note that not everything found in a hospital or in a healthcare setting will fall within scope. Only devices or accessories of such devices that fulfil a specific definition can be CE marked.
The Directive defines a medical device as any instrument, apparatus, appliance, software, material or other article that is intended to be used for the purposes of (where appropriate) diagnosis, prevention, monitoring, treatment, alleviation or compensation of a disease, or an injury or a handicap. The Directive also covers ‘devices’ used for the investigation, replacement or modification of the anatomy or of a physiological process, and of control of conception. As with the majority of the Directives, there is also a list of exclusions, with two most prominent being the Active Implantable Medical Devices and In-Vitro Diagnostic Medical Devices Directives.
A wide range of devices are covered by the Medical Devices Directive (MDD) and naturally some of the devices are deemed to pose a higher risk than others, for example the hazards associated with surgical tools are likely to be far greater when compared to a hospital bed. Instead of having one size fits all, the Directive deals with the wide range of devices by splitting them into one of the four classes (Classes I, IIa, IIb and III).
Accessories, whilst not being a device by themselves, are intended (by its manufacturer) to be used with a device, for the device to function as intended by the manufacturer. Accessories shall be treated as a device and shall be classified in their own right separately from the device with which they are to be used.
Many of the other ‘Product Directives’ have links to the Medical Devices Directive; predominately related to exclusions. For example, devices covered by the MDD, are excluded from the Low Voltage, Electromagnetic Compatibility, Pressure Equipment (Category 1 and SEP only) Directives. The MDD also states that were a relevant hazard exists, devices which are also machines as per the Machinery Directive, shall also comply with the relevant Essential Health & Safety Requirements of the Machinery Directive. The requirement shall only be applied to the extent where they are more specific than the essential requirements set out in the MDD.
CONFORMITY PROCEDURES
The route to conformity is very much dependent upon the classification of the device. Class I devices can be self-declared, whereas any other class requires the involvement of a Notified Body. Classification is decided upon establishing the applicable rule within Annex IX of the Medical Devices Directive. From here the route to conformity is explained within Article 11 and the applicable Annex.
For Class I devices (other than custom-made or devices intended for clinical investigations), the conformity assessment procedure is set out in Annex VII and is known as the ‘EC Declaration of Conformity.’
Whilst other Product Legislation requires manufacturers to undertake a risk assessment, the Medical Devices Directive goes further and effectively requires a Risk Management System (RMS) to be implemented. The RMS not only deals with the identification of the initial hazards associated with a device, but also has the procedures for undertaking post market surveillance. Whilst the Directive does not set out a formal procedure, a harmonised European Standard (EN ISO 14971) is available to be used.
Finally, the requirement to register the company with an enforcement authority is unique to the Medical Devices Directive. In the UK, manufacturers would register themselves with the MHRA (at the cost of a small administration charge). Registration is on a per-product-code basis, not necessarily on a per-product basis. Multiple codes may apply where a manufacturer has a wide product portfolio, however, the registration form allows this to be done in a single application.
HOW WE CAN HELP YOU:
The CE Marking Association have a range of services to assist manufacturers, importers and users of Class I Medical Devices with a range of services, as well as providing advice for the Class IIa & b and Class III Devices too. Here are some of the services on offer:
In-vitro Diagnostic Medical Devices:
There is a wide range of ‘devices’ that are intended to be used in medical applications and the majority of these ‘medical devices’ will come under the Medical Devices Directive, but there are also two additional Directives that cover two specific areas; ‘In-Vitro’ and ‘Active-Implantable.’
In Vitro is Latin for in glass, which gives a good clue to as to what is in scope; effectively the In Vitro Diagnostic Medical Devices (IVDMD) Directive applies to any medical device (as defined under the Medical Devices Directive) which is intended to be used for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
– concerning a physiological or pathological state, or
– concerning a congenital abnormality, or
– to determine the safety and compatibility with potential recipients, or
– to monitor therapeutic measures
The Directive (98/79/EC, as amended), which came into force on the 7th June 2000 applies to both devices and accessories, which could be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in the combination of other devices.
CONFORMITY REQUIREMENTS
The procedure for CE marking is dependent upon the type of device and may need the involvement of a Notified Body;
Why Choose Neozenith for CE Marking Certification?
For over 5 years, we have worked successfully with Electrical and Electronic, Construction, Machinery, Medical Devices product manufacturers, importers, in India to help them better manage risk and assure regulatory compliance. The reassurance of consulting an officially recognized conformity assessment body like Neozenith is invaluable. Our staffs keep us updated for the development of international, industry, and regulatory standards worldwide, keeping you and us at the forefront of changes in the various approvals requirements and certification methods.
Together, we acknowledge your desire to create a product that is aesthetically pleasing as well as safe, reliable, high performance and efficient. Providing you with the highest levels of service is a priority for us.
What is CDSCO?
CDSCO stands for Central Drugs Standard Control Organisation, which comes under the Ministry of Health and Family Welfare, which is headquartered in Delhi. The CDSCO is the Indian regulatory body responsible for the approval, registration and regulation of drugs, medical devices, and other health related products in India. The rules and procedures involved in obtaining CDSCO registration in India are also laid down by the CDSCO under the Drugs and Cosmetics Act, 1940, the Medical Device Rules, 2017 and the Cosmetics Rules, 2020.
MEDICAL DEVICE STATUS
Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified medical devices, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022 all Class A and B medical devices must have Import Licenses prior to importation. All remaining Class C and D devices not already Notified will need to have Import Licenses by October 1, 2023. Medical devices that do not currently require Import Licenses must still register their product(s) through an ePortal in a couple of days.
PRODUCT CLASSIFICATION
Medical devices are classified into 4 categories; A, B, C, and D based on risk level. The CDSCO fees for application processing depend on the device classification.
Class A products are further divided into 2 categories to ascertain if CDSCO license or CDSCO registration is applicable on the product:
So, the manufacturer whose products comes under classification of Class A (Sterile or measuring), Class B, Class C and Class D require license from CDSCO.
What Neozenith Consulting Services Do for You:
What is FDA 510 k Clearance?
Every device manufacturer wishes to trade in the US market for the classified medical device Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant for human use. But must submit FDA 510 k unless the device is exempt from 510 k necessity of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and does not overreach the circumstance of exemptions of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval. The applicant must measure their medical device to one or more similar legally marketed devices to support their substantial equivalency claims. And important to note that FDA does not execute 510 k pre-clearance facility inspections. The applicant may market their device immediately after 510 k clearance is permitted at any time after FDA 510 k clearance.
The FDA does not “approve” FDA 510 k submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).
Types of 510(k)
There are typical 3 types of 510(k) established under the US FDA clearance system. The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. These Programs were previously described in The New 510(k) Paradigm guidance. In 2019, the FDA split “The New 510(k) Paradigm guidance into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors.
Traditional 510(k):
This type of 510(k) is what is known as the original 510(k) submission or for a change/modification done to a previously cleared device under 510(k). This may be used under any circumstances.
Abbreviated 510(k):
This type of 510(k) is when the submission relies on:
Special 510(k):
This type of 510(k) is considered when there is modification to a device however modification should have no effect on intended use or alter the fundamental scientific technology. Examples for these modifications can include:
Where to start US FDA 510 k clearance Process.
FDA 510 k service is an online process, starts from classifying the devices & gathering information about the company products and then uploading them, through an online process. For class II devices, there is a process called the US FDA 510 k process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.
Who needs FDA 510 k and Why?
The domestic medical device manufacturers from any country trying to introduce a new device to the US market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device. In simple words, FDA 510 k is the name of a process, but technically it is a complicated and equally important process to submit your device documentation for clearance, to determine whether the device is safe and effective and hence permissible to legally sell in USA market.
Device identifications point for FDA 510 k
A device is considered identical only if, in comparison to a predicate it
FDA 510 k medical device approval process
State of considerable equivalence does not mean the new and predicate devices must be identical. Significant equivalence is established with respect to the intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labelling, biocompatibility, standards and other characteristics, as applicable. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the US market.
Preparation for FDA 510 k Application
Anyone who want to sell a device in the U.S. It is required to make the US FDA 510 k submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. Change in the intended use of a device which you already have in commercial distribution. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. A new US FDA 510 k submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use. The medical device manufacturer which makes the products GMP non-exempted are expected to implement the 21 CFR Part 820 as a quality management system.
The products which are marked as GMP Non-exempted the quality management system as per 21 CFR Part 820. The US FDA 510 k submission shall be prepared and submitted along with the review fees, the US FDA 510 k review fees can be remarkably reduced based on the turnover. The entities including its affiliates shall have less than 100 million dollars turnover to be qualified as SBU (Small Business Unit). The review is conducted by CDRH (Centre for Devices and Radiological Health) and raises queries if any. After the successful completion of the activity, the US FDA 510 k number is approved. After US FDA 510 k approval, the Establishment registration and device listing shall be done in order to supply products in the US.
What is an Acceptance Review?
Once Acknowledge letter is sent to applicant the DCC routes to appropriate ODE or OIR division and the Lead Reviewer conducts the Acceptance Review
Acceptance review usually results in:
The applicant has 180 calendar days to fully address the deficiencies cited in the RTA Hold. If this is not done, the 510(k) is considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitters will need to submit a new, complete 510(k) to pursue FDA marketing clearance for that device.
Neozenith Consulting Services is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval. We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.
What is a Substantive Review?
During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.
The Substantive Interaction communication is typically:
Medical Device 510(k) Submission Consulting for FDA Clearance
Every year the US FDA “approves” more than 2,000 traditional medical device FDA 510(k) submissions. A significant number of additional FDA submissions are rejected or abandoned by the manufacturer because the required testing was not conducted, guidance was not followed, or other requirements were not met.
Our experienced 510(k) consultants will increase your chances of getting FDA approval, and get it done faster
If you have a medical device that’s ready for commercialization, Neozenith can help you navigate the FDA approval (clearance) process. We specialize in medical device compliance and our team of 510(k) consultants understands how the FDA submission process works and what pitfalls to avoid. As a result, we can generally prepare and submit your 510(k) application more quickly, with less chance of receiving an initial “Refuse to Accept” (RTA) hold or an Additional Information (AI) request from the FDA reviewer. Faster clearance from FDA means your device is generating sales sooner.
We achieve positive results using a proven process for preparing your 510(k) Premarket Notification to FDA
We are meticulous about preparation, and emphasize it because we have learned that spending time on preparation results in a higher rate of successful 510(k) submissions at less overall cost to our customers. Here’s how we will approach your medical device 510(k) application:
How long it will take to clear your medical device 510(k)
Even though FDA has a published goal to clear most 510(k) submissions within 90 days, those are working days and not calendar days. Also, if the FDA reviewer issues an AI request post-submission, their internal review clock stops and does not begin again until you provide them with the requested information. As such, the majority of medical devices clear the FDA 510(k) review process in 4-8 months. Simpler devices with limited testing requirements and well-known predicates will be on the short end of that range; more complex products on the long end.
