CE Marking for Medical Devices Class 2a 2b 3

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.

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