Medical   -   CE Mark for Medical Device Directive

Eurotech offers comprehensive and customized services for CE marking for Medical Device against 93/42/EEC & 2007/47/EC including Risk Analysis , customised training programs, testing from accredited third party labs , European Authorised Agency services, Certificate of Free sales, and Registration of products with authorities in Europe.

Eurotech provides across-the-board testing and certification services, channelise  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.

Eurotech provides comprehensive certification services, channelize you do every move of the CE process for medical devices.

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 

What is CE Marking?

What does CE on a product implies?

What is an European authorized Representative?

What are the responsibilities of an European Authorized Representative?

Is ISO 13485:2003 mandatory to obtain CE marking?

Steps for obtaining CE mark?

How the Medical devices are classified in Europe?

What is self certification of medical devices?

What kind of medical devices be self certified?

Are all types of medical devices needs to be registered?

What are standards? where to find the standards applicable to a particular medical device?

What is OEM & OBL?

What are the benefits of CE marking?

 

 

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.

What is an European authorized Representative?

Manufacturers residing outside European cannot apply for CE marking themselves and must appoint an European Authorized Representative (EAR) established within European community who on the behalf of non European manufacturer applies for CE making.

What are the responsibilities of an European Authorized Representative?

European Authorized representative acts as a point of contact between the manufacturer & the European notified bodies. His responsibilities involves Product registration, Incident reporting, Recall Assistance, change notification. 

Is ISO 13485:2003 mandatory to obtain CE marking?

CE making requires the implementation of Quality management system as per the Annex V & II of MDD 93/42/EEC as its amendment 2007/47/EC which is easily achieved by obtaining an ISO 13485:2003 certificate as this ISO standard compiles with both the annexes of MDD 93/42/EEC as its amendment 2007/47/EC. So ISO 13485:2003 is not mandatory but is an easy way to implement the QMS as per the EU requirements in order to get CE certificate.

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.

 

 

How the Medical devices are classified in Europe?

The medical devices are classified as

a)      Class I (non sterile non measuring)

b)      Class I(sterile or measuring function)

c)       Class II a

d)      Class IIb

e)      Class III

 on the basis of the risk as imposed by them as per the annex IX of MDD (93/42/EEC and its amendment 2007/47/EC). Manufacturer can himself classify his devices based on the intended uses and duration of use as per the guidance of MDD. if there is any confusion related to the classification the same can be confirmed from the notified body from which he has applied for CE mark.

What is self certification of medical devices?

Self certification is the process used for CE making of medical devices which falls under class I (non sterile non measuring function). For self certification manufacturer just have to prepare a Technical dossier of the device, Declaration of Conformity, and then his EAR registers medical devices with his local competent authority. Then affixes the CE mark on device. This process is quite simple than the certification process for higher class of medical devices as it does not requires QMS implementation & involvement of notified bodies.

What kind of medical devices be self certified?

only class I devices which are non sterile & does not have any measuring function can be self certified by the manufacturer.

Are all types of medical devices needs to be registered?

No, only class I devices that has been self certified by manufacturers needs to be registered by his European authorized representative with his local competent authority.

What are standards? where to find the standards applicable to a particular medical device?

Standards are the guidance documents. If a  product is stated of complying with particular standards it means that it meets all the aspects of safety & performance as mentioned in that particular standard. There are many general (ISO 13485:2003, ISO 14971:2012, ISO 10993, EN 980:2008)& product specific standards which needs to be applied to a product in order to get CE mark. List of general & product specific standards is available on ec.europa.eu.

What is OEM & OBL?

OEM stands for original equipment manufacturer is the original manufacturer of the product.

OBL stands for own brand labeler is not the original manufacturer and re labels devices manufactured by OEM’s and place them in market in their name.

 

 

What are the benefits of CE marking?

The whole process of CE is quite simply and beneficial. CE marking is   a mark of Quality that opens gateways not only for European market but for non European market as well.  Manufacturer who has obtained CE marking for his product can sell his device in non European market as well by obtaining a certificate of free sales(FSC) from the health ministry of the country to which he wants to export on the basis of the CE certificate.

 

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