CE Certification, CE Mark, CE Certification Consultancy

What is CE Marking?

CE marking ( conformity European) is a trade passport for the products destined for European market. It is the mandatory conformity procedure through which every product has to pass prior to its marketing, distribution & sales in Europe.
What does CE on a product implies?

CE marking affixed onto a product verifies that the product meets as many EC directives as applicable to them.

Steps for obtaining CE mark?

The steps for obtaining CE marking are:

a) Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
b) Appoint an European authorized representative (required by non EU manufacturers only)
c) Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
d) Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
e) Classify General & product specific standards as applicable to the medical device.
f) Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
g) Submit the technical dossier & QMS documents to notified body for approval.
h) Audits on site of QMS and technical files by notified body.
i) Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive )
j) Affix CE mark on the medical device.
k) Translate IFUs & labels to the local language of the country to which you want to export.
l) Start distribution of CE affixed medical device in Europe.

Eurotech scope for CE certification by the following directives:

• Medical Device Directive (MDD)
• Pressure Equipment Directive (PED)
• Transportable Pressure Equipment Directive (TPED)
• Simple Pressure Vessels Directive (SPVD)
• Lift Directive (LD)
• Machinery directive (MD)
• Low Voltage Directive (LVD)
• EMC Directive
• RoHS Directive
• Active Implantable Medical Device Directive
• General Product safety (GPS)
• Construction Product Directive (CPD)

CE Marking Certification For Pressure Equipments PED

if you are looking for CE Marking Certification service For Pressure Equipments PED, Eurotech Certification Body Providing CE Marking Certification For Pressure Equipments PED. We have been counted amongst the most trusted names in this business, engaged in rendering CE Marking On Pressure Equipment. Our service range is widely demanded in different industries. To get the total satisfaction of customers, we provide this CE Marking On Pressure Equipment at most reasonable price.

Features:

• Timely execution
• Timely service
• Efficient execution team

Since 30/05/2002 the PED is obligatory throughout the EU.

The directive supplies, together with the directives incidental to simple pressure vessels 2009/105/EC, transferable pressure equipment 99/36/EC & Aerosol Providers 75/324/EEC a comprehensive structure for safety.

The Directive business concern items such as crafts, pressurized store containers, heat exchangers, steam setups, boilers, industrial piping, safety devices and pressure supportive. Such pressure equipment is widely used in the activity industries oil and gas, chemical, pharmaceutic, plastics & rubber & the food & drink industry, full temperature process industriousness glass, paper & commission, energy manufacture & in the supply of utility, heating plant, air conditioning & gas store & transportation system.

Pressure Equipment Directive compliance complete & above other demands, usually needs making design calculations as per EN Standard and success Special process such as welding as per EN Standards & assuring that the material used is like to that specified in the relevant EN standards

Pressure Equipment Directive 97/23/EC (PED):

In order to ensure a consistent practical application of the PED (Pressure Equipment Directive 97/23/EC), Guidelines are developed in agreement by the Administrative body WGP (Working Group Pressure ). This working group, made as a result of Section 17 of the Pressure Equipment Directive, which requests the Member Authorities to get together in order to assist the functioning of this Directive. It is combined of agents of Members States, European organizations, the Notified Bodies Assembly and CEN.

Status of the pressure equipment directive guidelines:

The Pressure Equipment Directive (PED) Guidelines are not a legally constricting interpretation of the Directive. The legally constricting text remains that of the Directive 97/23/EC. However the guidelines symbolize a reference for ensuring conformable application of the directive. They represent, unless pointed differently in the individual guideline text, the solid opinion of the member states goods.

PED classification of the guidelines:

The guidance carry a X/Y kind of listing. The 1st .No X assistant to the efficient, The 2nd Y is a serial number. The numbers X associate to the pursuing capable:

Scope & Exclusions of the Directive

• Classification and categories
• Assemblies
• Evaluation assessment procedures
• Interpretation of the essential conditions on design
• Interpretation of the essential conditions on manufacturing
• Interpretation of the essential conditions on materials
• Interpretation of other essential conditions
• Miscellaneous
• General / Horizontal issues

CE Marking Certification from Notified Bodies

Eurotech ACSPL representing the European Notified Bodies for various certification.
We are engaged with the following 3-4 Notified Bodies for Certification like-

1. Eurocert of Greece to providing CE certification on LVD ,PED ,SPVD, MD and lift directive as well where notified body is mandatory. And its Notified Body No. is - 1128 on EU database.

2. DEDAL of Bulgeria to providing CE Marking Certification on Construction products which come in CPR directives. And from July 2013 It became mandatory to make CE certify your product if you are exporting your product in Europe. And its Notified Body No. is - 1922 on EU database.

3. Kiwa Cermet of Italy to providing CE marking certification on Medical products. And its notified Body no. is - 0476 on EU database.

Requirements of notified body:

• Availability of personnel and required Equipment
• Independence & equality of the personnel
• Technical competence to carry out the Conformity Assessment
• To have a secrecy Policy
• To take out personal Accountability Insurance

What is CE Marking?

CE marking ( conformity European) is a trade passport for the products destined for European market. It is the mandatory conformity procedure through which every product has to pass prior to its marketing, distribution & sales in Europe.

What does CE on a product implies?

CE marking affixed onto a product verifies that the product meets as many EC directives as applicable to them.

Steps for obtaining CE mark?

The steps for obtaining CE marking are:

a) Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
b) Appoint an European authorized representative (required by non EU manufacturers only)
c) Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
d) Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
e) Classify General & product specific standards as applicable to the medical device.
f) Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
g) Submit the technical dossier & QMS documents to notified body for approval.
h) Audits on site of QMS and technical files by notified body.
i) Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive )
j) Affix CE mark on the medical device.
k) Translate IFUs & labels to the local language of the country to which you want to export.
l) Start distribution of CE affixed medical device in Europe.

Eurotech scope for CE certification by the following directives:

• Medical Device Directive (MDD)
• Pressure Equipment Directive (PED)
• Transportable Pressure Equipment Directive (TPED)
• Simple Pressure Vessels Directive (SPVD)
• Lift Directive (LD)
• Machinery directive (MD)
• Low Voltage Directive (LVD)
• EMC Directive
• RoHS Directive
• Active Implantable Medical Device Directive
• General Product safety (GPS)
• Construction Product Directive (CPD)

CE Certification Machinery - Machinery Safety Testing IEC Standards IEC 60204: Ed 2.1 2009

If you are looking for CE Certification service for your Machinery, Eurotech Certification Body provide onsite testing for IEC 60204 provides requirements and recommendations relating to the electrical equipment of machines so as to promote:

• Safety of persons and property
• Consistency of control response
• Ease of maintenance.

High performance is not to be obtained at the expense of the essential factors mentioned above. An example of a possible application of these requirements is a group of machines used in the production of discrete parts where a failure in such production machines or manufacturing systems or cells can have serious economic consequences.

What is CE Marking?

CE marking ( conformity European) is a trade passport for the products destined for European market. It is the mandatory conformity procedure through which every product has to pass prior to its marketing, distribution & sales in Europe.
What does CE on a product implies?

CE marking affixed onto a product verifies that the product meets as many EC directives as applicable to them.

Steps for obtaining CE mark?

The steps for obtaining CE marking are:

a) Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
b) Appoint an European authorized representative (required by non EU manufacturers only)
c) Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
d) Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
e) Classify General & product specific standards as applicable to the medical device.
f) Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
g) Submit the technical dossier & QMS documents to notified body for approval.
h) Audits on site of QMS and technical files by notified body.
i) Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive )
j) Affix CE mark on the medical device.
k) Translate IFUs & labels to the local language of the country to which you want to export.
l) Start distribution of CE affixed medical device in Europe.

Eurotech scope for CE certification by the following directives:

• Medical Device Directive (MDD)
• Pressure Equipment Directive (PED)
• Transportable Pressure Equipment Directive (TPED)
• Simple Pressure Vessels Directive (SPVD)
• Lift Directive (LD)
• Machinery directive (MD)
• Low Voltage Directive (LVD)
• EMC Directive
• RoHS Directive
• Active Implantable Medical Device Directive
• General Product safety (GPS)
• Construction Product Directive (CPD)

CE Marking Certification from Notified Bodies

Eurotech ACSPL representing the European Notified Bodies for various certification.
We are engaged with the following 3-4 Notified Bodies for Certification like-

1. Eurocert of Greece to providing CE certification on LVD ,PED ,SPVD, MD and lift directive as well where notified body is mandatory. And its Notified Body No. is - 1128 on EU database.

2. DEDAL of Bulgeria to providing CE Marking Certification on Construction products which come in CPR directives. And from July 2013 It became mandatory to make CE certify your product if you are exporting your product in Europe. And its Notified Body No. is - 1922 on EU database.

3. Kiwa Cermet of Italy to providing CE marking certification on Medical products. And its notified Body no. is - 0476 on EU database.

Requirements of notified body:

• Availability of personnel and required Equipment
• Independence & equality of the personnel
• Technical competence to carry out the Conformity Assessment
• To have a secrecy Policy
• To take out personal Accountability Insurance

Why Eurotech :

1) -- Well experience team of technical expert & auditors
2) -- Always meet the committed period or dead line & 100% guidance from project start to the end.
3) -- Having own NABL approved lab for Testing against IEC/EN/IS/BS standard
4) -- Most Competitive pricing
5)-- Ultimate solution for CE certification requirements.

 

CE Marking for Medical Devices Class 2a 2b 3

if you are looking for CE Mark Certification Service for Medical Devices Class 2a 2b 3, Eurotech Certification Body providing CE Marking Certification for Medical Devices Class 2a 2b 3. Eurotech involved in providing CE Marking On Electro Medical Equipment. Our service range is highly appreciated amongst customers for its high reliability and timely execution. This CE Marking On Electro Medical Equipment is provided by our team of skilled professionals Banking on the skills of our qualified team of professionals.

Features:

• Widely preferred
• Provides easy and satisfactory cleaning
• As per client's specification

Eurotech offers comprehensive and customized services for CE marking for Medical Device against 93/42/EEC & 2007/47/EC including risk analysis, customized training programs, testing from accredited third party labs, European authorized agency services, certificate of free sales, and registration of products with authorities in Europe.

Eurotech provides across-the-board testing and certification services, channelize you with every footstep of CE Mark operation for medical devices. In order to locate your product in the European industry, they must meet the demands of the applicable product directives. We help you to understand and meet these directives to check your product accomplishes the CE Mark process with efficiency.

Process of Medical Device have to follow to be placed on the market. All medical device placed on the European industry must satisfy with the admissible regulation noticeably with Medical Device Directive 93/42/EEC, or with the Operating Implant Devices Directive 90/385/EEC or with the In Vitro Medical Devices Directive 98/79/EC. You first need to complete in case the devices you propose to manufacture or import falls under any of these Directives.

All medical devices must fulfill the needed requirements set out in the above specified Device Directives. Where applicable, related standards may be used to establish compliance with the needed requirements explain in the Device Directives.

Some common FAQs for CE marking for medical devices are given below:

The steps for obtaining CE marking are:

• Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices)
• Appoint an European authorized representative (required by non EU manufacturers only)
• Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
• Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC
• Classify General & product specific standards as applicable to the medical device
• Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc
• Submit the technical dossier & QMS documents to notified body for approval
• Audits on site of QMS and technical files by notified body
• Prepare a declaration of conformity (DOC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive
• Affix CE mark on the medical device
• Translate IFUs & labels to the local language of the country to which you want to export
• Start distribution of CE affixed medical device in Europe

How the Medical devices are classified in Europe?

The medical devices are classified as:

• Class I (non sterile non measuring)
• Class I (sterile or measuring function)
• Class II a
• Class II b
• Class II
• CE Certification Consultancy Services
• CE Certification Services
• Medical Device Testing

What is CE Marking?

CE marking ( conformity European) is a trade passport for the products destined for European market. It is the mandatory conformity procedure through which every product has to pass prior to its marketing, distribution & sales in Europe.

What does CE on a product implies?

CE marking affixed onto a product verifies that the product meets as many EC directives as applicable to them.

Steps for obtaining CE mark?

The steps for obtaining CE marking are:

a) Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
b) Appoint an European authorized representative (required by non EU manufacturers only)
c) Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC)
d) Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
e) Classify General & product specific standards as applicable to the medical device.
f) Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
g) Submit the technical dossier & QMS documents to notified body for approval.
h) Audits on site of QMS and technical files by notified body.
i) Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive )
j) Affix CE mark on the medical device.
k) Translate IFUs & labels to the local language of the country to which you want to export.
l) Start distribution of CE affixed medical device in Europe.

Eurotech scope for CE certification by the following directives:

• Medical Device Directive (MDD)
• Pressure Equipment Directive (PED)
• Transportable Pressure Equipment Directive (TPED)
• Simple Pressure Vessels Directive (SPVD)
• Lift Directive (LD)
• Machinery directive (MD)
• Low Voltage Directive (LVD)
• EMC Directive
• RoHS Directive
• Active Implantable Medical Device Directive
• General Product safety (GPS)
• Construction Product Directive (CPD)

CE Marking Certification from Notified Bodies

Eurotech ACSPL representing the European Notified Bodies for various certification.
We are engaged with the following 3-4 Notified Bodies for Certification like-

1. Eurocert of Greece to providing CE certification on LVD ,PED ,SPVD, MD and lift directive as well where notified body is mandatory. And its Notified Body No. is - 1128 on EU database.

2. DEDAL of Bulgeria to providing CE Marking Certification on Construction products which come in CPR directives. And from July 2013 It became mandatory to make CE certify your product if you are exporting your product in Europe. And its Notified Body No. is - 1922 on EU database.

3. Kiwa Cermet of Italy to providing CE marking certification on Medical products. And its notified Body no. is - 0476 on EU database.

Requirements of notified body:

• Availability of personnel and required Equipment
• Independence & equality of the personnel
• Technical competence to carry out the Conformity Assessment
• To have a secrecy Policy
• To take out personal Accountability Insurance

Why Eurotech :

1) -- Well experience team of technical expert & auditors
2) -- Always meet the committed period or dead line & 100% guidance from project start to the end.
3) -- Having own NABL approved lab for Testing against IEC/EN/IS/BS standard
4) -- Most Competitive pricing
5)-- Ultimate solution for CE certification requirements.

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

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

Mumbai Chennai Ahmedabad, New Delhi