I am green in CE marking application.:o

Our company produce products fall into Class 1. For Class 1 products, our company need to make a self-declaration. What is included in the self-declaration? Will there be any further testing of our products before/after making the declaration?

Thank you for all your kind help.

Are you certified to ISO?

Recently we don't have any ISO.
Is it a must to have it?

If it is a sterile Class I product you need to be certified to ISO 13485 - relating to Quality Assurance of the production. And, you need a Declaration of Conformity, Design Info, compliance to MDD, Clinical Data, Risk Analysis, Post Market Surveillance and system for reporting incidents.

If it is non-sterile, you need the above too, but you do not need to be certified to ISO 13485, but you still need a documented QMS, and a Notifying Body needs to approve the device. :bigwave:

Thank you for your prompt reply.^ ^
We are doing non-sterile products. I wonder if the clinical data and risk analysis need to be done by some standard testinng company or by ourselves?

There is just a question if have got a measuring function on your product. If so you the certificate from a notified body as well.

Yet if the product actually falls into class I non-sterile without measuring option then the conformity assessment procedure does not involve any third party.
As far as regulatory requirements are required you need to follow it yourself (just as Gert mentioned) and finally you end up with saying that your product is in conformance with Essential Requirements posed in the MDD - being your declaration of conformity.

But the way does not end here. As I can see your located in Hong Kong so in order to be in conformance with the legal requirements of MDD you need to appoint an authorised representative who will be the contact person for your products for all the Competent Authorities within EU. The representative is a company or person located within the EU with whom you have the appropriate agreement. You need to mention this company on your label.
Authorised representatives will charge you some money of course.

Depending on the location of the authorised representative you will need to follow the registration procedure within one of the Competent Authorities in the EU. In my opinion the UK jurisdiction is very favourable in this respect. The mentioned by Gert documents will come in handy than. Should you need further help in appointing the representative please let me know and I will be able to assist your further. Should you require some further quick consultancy this can also be arranged.

Just keep in mind that assessment procedure for class I non-sterile products does not mean issuing the declaration of conformity.

Good luck!

Carisa,

you need to comply with Annex VII of the MDD 93/42/EEC (http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML):
In short: you have to do the same things, as if you produce a class IIa device, but you do not need to involve a notified body and you do not need to have a certified quality management system - but you need some QM system to manage the requirements of the MDD:

The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established in the Community who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured.

Where neither the manufacturer nor his authorized representative are established in the Community, this obligation to keepthe technical documentation available must fall to the person(s) who place(s) the product on the Community market.

The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:
— a general description of the product, including any variants planned,
— design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,
— the descriptions and explanations necessary to understand the above mentioned drawings and diagrams and the operations of the product,
— the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,
— in the case of products placed on the market in a sterile condition, description of the methods used,
— the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, — the test reports and, where appropriate, clinical data in accordance with Annex X,
— the label and instructions for use.

The manufacturer shall institute and keepupto date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. He shall notify the competent authorities of the following incidents immediately on learning of them:

(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.

The medical devices directive does not require a company to be ISO13485:2003 registered. What it does require is a documented quality system depending on which annex or route taken to CE certification. However it is advantageous to be certified to ISO13485:2003 particularly for the new member countries of the EU and if you export to countries outside EU.

Class i non sterile and non-measuring devices need to be registered with a competent authority and not a notified body.

WEHTTAM

I am out of the US and am looking at doing the same thing.

What do you mean by a "competent authority"?

:thanx:

For a medical device to be sold anywhere in Europe you need to comply with the Medical Devices Directive. Strictly speaking you need to comply with the transposition of the MDD into the local national law(s). The laws are enforced by the Competent Authorities.

The CAs are the individual European national authorities, usually a department of the relevant Ministry of Health.

For UK it is the MHRA (http://www.mhra.gov.uk), France is AFSSAPS (http://agmed.sante.gouv.fr/ang/indang.htm), Germany is BfArM (http://www.bfarm.de/EN/Home/homepage__node.html) etc.


Your declaration of conformity is exactly what it sounds - a legal declaration that you have done everything you need to do to comply with the laws of the countries into which you sell the product. Legal penalties for failing to comply can be severe as you can imagine.


The declaration of conformity (somewhat confusingly) is also the process you need to go through to get your company and product in a fit state to sign the declaration.

Note that there is now a consolidated text of the revised MDD. Although key elements of the revision don't kick in until 2010 you might as well do the "right thing" immediately, save you having to re-adjust later. That doc is linked on another recent thread.


There are a bunch of things you need to do to comply, more if you market a Class I sterile, or Class I device with a measuring function (includes graduated syringes, measuring spoons, ophthalmic instrument with a graticule etc), and yet more if your company is based outside the European Union.

Roland Cooke-

Thank you for your help. It is a class I non-sterile/non-measuring, in the US. Your information puts me on my way :)

:thanx:

Class I non-measuring / non-sterile, applies to the EU, not to the USA.

There are also Class I devices in the US, with a high level of overlap.

Hi,
Can anybody help me finding an independent authorized representative in UK for CE Marking of a calss 1 device.
Thanks.

Hi,
Can anybody help me finding an independent authorized representative in UK for CE Marking of a calss 1 device.
Thanks.

Off the top of my head I seem to recall that BSI, BVQI, SSG and TÜV have branches in the UK.

Off the top of my head I seem to recall that BSI, BVQI, SGS and TÜV have branches in the UK.


These are Registrars/Notified Bodies, not Authorised Representatives. (But thanks for the advert anyway!)

Google is your friend.... (http://www.google.co.uk/search?hl=en&q=authorised+representatives&btnG=Search&meta=cr%3DcountryUK%7CcountryGB)

See if you can ID companies who are selling Class I in EU

Hi,
Can anybody help me finding an independent authorized representative in UK for CE Marking of a calss 1 device.
Thanks.

By the way your authorized representative (AR) can be based in any EU country not just the UK ...

if you are interted in finding one then you can PM me if you wish...

In identifying one be certain they can meeet their legal requirements -- particularly their vigilance requirements -- and make sure you have a very good technical agreement in place...as they can act as your distributor ..

Whilst it may seem easier to place a Class I Med Device on the EU market there are still many legal requirements necessary - I have just done one and the risk analysis was a bit tricky ..

Be mindful of the fact that AR may need to have your technical file ..


Also note that (as highlighted in earlier psots) that Class I devices which have a measuring function or designed to be sterilised before being placed on the market must have those procedures assessed by a notified body.

This thread gives information on the content of DoCs. (http://elsmar.com/Forums/showthread.php?t=23799)

The medical devices directive does not require a company to be ISO13485:2003 registered. What it does require is a documented quality system depending on which annex or route taken to CE certification. However it is advantageous to be certified to ISO13485:2003 particularly for the new member countries of the EU and if you export to countries outside EU.

Class i non sterile and non-measuring devices need to be registered with a competent authority and not a notified body.


ALL Class I medical devices (whether sterile or not, with or without measuring function) need to be registered with a competent authority.