CE Marking Approval for Medical Devices, Guidelines for Classification of Medical Devices

CE Marking for Medical Devices, CE Mark, requirements, certification, approval, testing, European directives and standards

If you are looking for CE Marking Certification for Medical Devices, If you want to sell your medical device/Products in European countries you will need a CE Marking Certificate on the Medical products to show it complies with European health, safety & environmental protection legislation. If you’re looking for a CE Mark Consultants to help you achieve a CE Certification, look no further than Eurotech.                                                             

Eurotech Certification Body provides comprehensive testing and certification services, guiding you through every step of the CE Marking process for medical devices in India.
In order for your products to be placed on the European countries, they must meet the requirements of the relevant product/Devices directives. We help you understand and meet these directives to ensure your product completes the CE Mark Certification process efficiently & successfully.

Before the CE Mark may be affixed to a medical device or Medical Products & legally sold within the European Union, the manufacturer/Exporters/Suppliers must complete the following Guidelines:

• (Technical File) Prepare for Technical Documentation to show the products compliance with applicable essential requirements & conformity assessment procedures of the applicable device directive
• Register their Medical device with the appropriate Competent Authorities
• Receive a Medical device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)

8 Step to Get CE Marking for Medical Devices in India:

Navigating the CE Mark Certification process does not have to be painstaking. In fact, Eurotech makes it as easy as the following steps:

1. Classify your product - Class I, IIa, IIb, and III according to the classification rules in Annex IX of the Medical Devices Directive 93/42/EEC MDD:

• Class I. Medical Devices with low risk such as external patient support products.
• Class IIa/b. Medical Devices with medium risk such as electro-medical devices.
• Class III. Medical Devices with high risk such as cardiovascular catheters.
• Some Class I and all Class IIa, IIb, and Class III Medical devices require Notified Body approval.

2. Determine your certification process based on your device class

3. Fulfill the essential requirements - Ensure that your medical device fulfills the essential requirements in Annex I of the Medical Device Directive MDD.

4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.

5. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obligated to report this to the authorities.

6. Issue a Declaration of Conformity

7. Save the documentation for five years - The new revision of the MDD Medical Devices Directive 93/42/EEC requires that records for implantable devices be kept for 15 years. Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production.

8. Register with the appropriate authorities in Europe

CE Marking in India – Entry to European Market | Get a quote for Testing to support CE Marking.

Contact Now! Mr. Puneet Sharma
M: 08196980555 E: CE.Marking.Certification@Gmail.Com

Have a Question? Please Fill out the Enquiry Form below:

CE Marking for Industrial Control Panels

How to CE Mark for Industrial Control Panels

If you are looking CE Marking Certification for Industrial Control Panels/ Electrical Control Panel, Eurotech Certification Body Providing CE Certification for Industrial Electrical Control Panels with Testing In India, Mumbai, Chennai, Ahmedabad, Pune, Gujarat, Maharashtra, New Delhi, Chandigarh, Panchkula, Mohali, Ludhiana, Baddi, Ambala, kolkata, bangalore, Gandhi Nagar, Jamnagar, Rajkot, Surat, Vadodara

Most products can be labeled with the CE Marking Certification based upon a manufacturer's Declaration of Conformity. This declaration must be backed up with test data and a CE test report.
Eurotech can perform all of the necessary testing and provide the required CE reports for:

• EU Low Voltage Directive (LVD) Guidance
• Machinery Directive (MD) - European Commission
• Electromagnetic Compatibility (EMC) Directive
• R and TTE Directive
• Medical Device Directive (MDD)
• ATEX Directive
• Ecodesign Directive 2009/125/EC
• Energy Labeling Directive 2010/30/EU
• EC’s Guide on Implementation of EU Directives

if you are interested to Get CE Certified your electrical control panel, Please Send us the following information to quote you:

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

Get a quote for Testing to support CE Marking.
Contact Now!
Puneet Sharma
M: 08196980555 E: CE.Marking.Certification@Gmail.Com

CE certification on Daylight Hydraulic Press

CE certification for Daylight Hydraulic Press

If you are looking for CE certification Body for your Daylight Hydraulic Press, Eurotech Certification Body Providing CE Marking Certification for Daylight Hydraulic Press as per Applicable directive :- Machinery and Low Voltage Directive (LVD).

Our service include: technical guidance, documentation guidance, on site safety testing from NABL lab against EN60204-1, pre audit, audit and CE certification from notified body Eurocert-1128.

if you are interested to Get CE Certified your Daylight Hydraulic Press , Please Send us the following information to quote you:

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

Contact Now!
Puneet Sharma
M: 08196980555 E: CE.Marking.Certification@Gmail.Com

CE Marking for Needle Destroyers

CE Marking Certification for Needle Destroyers

Eurotech Authorized Certification Notified Body with Product Testing Providing CE Certification service on Needle Destroyers as per Low voltage Directive (LVD)

If you are looking to avail CE Mark Certification Service for Needle Destroyers OR If your Buyers Demanding for CE Certification on Needle Destroyers . Get CE Certification for your Products,

Interested Please Send us the following information to quote you:

1. No of employees
2. Name of product
3. Product photograph
4. Intended use of the product
5. Technical specification of the product.

Contact Now!
Puneet Sharma | 08196980555 | Email:CE.Marking.Certification@Gmail.Com

CE Mark Certification for RO Plant

CE Mark Certification For RO Plant

If you are looking to avail CE Mark Certification Service for RO Plant. OR If your Buyers Demanding for CE Certification on RO Plant.

Eurotech Certification Body Providing CE Certification service on RO Plant as per Low voltage Directive (LVD) , Put our advisory, testing, and certification services to work for you and allow us to guide you through every step of the CE Marking process, CE Certification allows you to legally market and distribute your product within the European Market, and declares that, Get help obtaining the CE Marking Certification for your RO Plant. We offer CE Certification Testing & CE Marking Compliance services. Contact our specialists today.

Get CE Marking Certification services from Eurotech

Apply Now For CE Certificate

Contact Now!
Puneet Sharma
M: 08196980555
E: CE.Marking.Certification@Gmail.Com

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CE Marking For Hospital Rubber Coated Textiles and Fabrics

Eurotech And Meddevices Certification Body Providing CE Marking Certification Service on Rubberized Textile Fabrics - Hospital Rubber Sheeting Types: MRB/MRG, VFX – 05 & VFX - 06  as Per MDD Medical Devices Directive Class I

Interested Manufacturers , Suppliers, Traders, Exporters can drop their requirements with product technical details at (CE.Marking.Certification@Gmail.Com | Meddevices.net@gmail.com)

Best Regards,
Puneet Sharma 
08196980555

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CE Marking For Packaging Material for Terminally Sterilised Medical Devices

CE Marking For Packaging Material for Terminally Sterilised Medical Devices

Eurotech and Meddevices Certification Body Providing CE Marking Certification Service on Packaging Material for Terminally Sterilised Medical Devices as per MDD Class I

Steps for Class I medical devices compliance. Classification: ensure the device is a Class I medical device. Choose Conformity Assessment Route: refer the flow

Looking for an EC/EU European Authorised/Authorized Representative? Register/Notify your MDD-Medical Devices and. IVDD-In Vitro Diagnostic Medical Devices

Interested Manufacturers , Suppliers, Traders, Exporters can drop their requirements with product technical details at (CE.Marking.Certification@Gmail.Com |Meddevices.net@gmail.com)

Best Regards,
Puneet Sharma 
08196980555

CE Marking For Sterilization And laboratory Equipments

Eurotech Certification Body Provide CE marking Certification Service on Sterilization And laboratory Equipment's As Per CE Mark-IVD (IVD-In Vitro Diagnostic Medical Devices)European IVD Regulatory Approval Process, In Europe, the In-Vitro Diagnostic Devices Directive (98/79/EC)

Eurotech and Meddevices can audit and certify your organization against 98/79/EC to enable use of the IVD CE Mark on your products.

Eurotech Certification Body IVD experts can assist you in complying with the In-vitro Diagnostic Device Directive 98/79/EC. Our affordable and practical approach to CE Marking for Medical Devices

Understanding the In Vitro Diagnostic Medical Devices Directive (98/79/EC). EU In vitro diagnostic medical devices (IVDs) are subject to the European Directive

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Interested Manufacturers , Suppliers, Traders, Exporters can drop their requirements with product technical details at (CE.Marking.Certification@Gmail.Com)

Best Regards,
Puneet Sharma 
08196980555

How to Get CE Certification in India?

It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking. Eurotceh Certification Body can help you gain easier access into the European market by ensuring your product meets all the CE mark requirements
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product

How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents: 
Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.

Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).

Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:

1. Module A: internal production control
2. Module Aa: intervention of a Notified Body
3. Module B: EC type-examination
4. Module C: conformity to type
5. Module D: production quality assurance
6. Module E: product quality assurance
7. Module F: product verification
8. Module G: unit verification
9. Module H: full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

CE Certification Services Directory of service providers in India, CE Marking and conformity, CE marking experts, EU Conformity Certificate · CE Marking Compliance · European CE Marking
Get CE Marking For Your Products. Call Toll Free : 8196980555

Best Regards,
Puneet Sharma
Email: CE.Marking.Certification@Gmail.com
Call: +91-8196980555