Hi,
Can anybody help me find an independent authorized representative in UK (or EU) for CE Marking of a calss 1 device.
Thanks.

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

Hi,

I offer this service for a number of clients. It does depend on whether you need a notified body or not. Also having the notified body as your representative can be very expensive.

In my last company, We had a class 1 device and we self-certified to CE. It is my understanding that you do not need a notifying body to cert you for Class 1 devices. Can someone verify this?

Hi,

Usually that is the case yes.

what kind of service are you looking for?

In my last company, We had a class 1 device and we self-certified to CE. It is my understanding that you do not need a notifying body to cert you for Class 1 devices. Can someone verify this?

It's only half true. And the wrong half is very wrong. ;)

You need to comply with Annex VII for Class I devices. If those devices are either sterile, or have a measuring function, or both, then Annex VII requires that you also comply with Annex V* for those aspects.
Annex V requires the intervention of a Notified Body to assess the (relevant aspects of the) quality system and the technical documentation.



*The revision of the MDD, coming out in March 2010, will also allow Annex II as an option for Class I sterile/measuring/both devices.

Roland,

What I should have said is that we were certified as ISO 13485 by a notifying body, but we self certified to CE for a class 1 devices that is sterile.

So a better response would be that you need to be certifed to ISO 13485 by a notifed body before you can self declare for CE mark for Class 1 device?

Roland,

What I should have said is that we were certified as ISO 13485 by a notifying body, but we self certified to CE for a class 1 devices that is sterile.

So a better response would be that you need to be certifed to ISO 13485 by a notifed body before you can self declare for CE mark for Class 1 device?


In and of itself, being registered to ISO13485 is irrelevant to meeting the requirements of Annex VII for a Class I product. You don't actually need a quality system, just good product (i.e. product that meets the requirements of the MDD e.g. Article 1, Annex I, Article 17 etc etc), plus a few procedures to meet the other regulatory requirements of Annex VII e.g. vigilance protocols.

In and of itself, being registered to ISO13485 is only peripherally relevant to meeting the requirements of Annex VII, plus the additional requirements of Annex V for a Class I sterile device. It is however a good idea, as in addition to the requirements above, you also need quality system control for at least those processes related to managing the sterility. (Those processes can be narrow or broad-based, depending on whom you talk to).
ISO13485 is not mandatory for compliance to the MDD, (no standard is). ISO13485 is "only" a harmonised standard...that makes it all-but mandatory (ish!), so you are in good shape so far!

So with ISO13485 explained, let's address your real requirement for a Class I sterile product. It's basically simple - you just need to sign the legal Declaration of Conformity confirming that you have done everything you need to do under the requirements of the MDD (or if you want to be a stickler, under the relevant UK Statutory Instrument).

So it's kinda important to find out what you need to do, before you blindly sign a declaration and end up making your lawyer cry!

Because at the end of the day EVERY medical device, regardless of class, is "self-declared" under the MDD. Every manufacturer takes final responsibility for the product when they sign that piece of paper.
It's just that part of the process for medium and high-risk devices includes getting third-party certification i.e. an EC certificate from a Notified Body.

Third party certification is also required for Class I sterile devices.

So to answer your question:

So a better response would be that you need to be certifed to ISO 13485 by a notifed body before you can self declare for CE mark for Class 1 device?

No, that's wrong. :notme:


ISO13485 is not the same as an EC certificate, although it can help you get EC certified.
You can only sign your Declaration of Conformity when you have done everything you need to.
One of the things you need to do is get EC certified (under Annex V for the sterility aspects of your products).

I hope that's clear. :)


Because the next thing to confuse the whole situation is registration of devices, which is often linked to reimbursement, but is also a means whereby the Competent Authorities can track devices sold within their region.
Typically in the UK you only register Class I devices, which would (IIRC) include Class I sterile devices.

In some other countries (Italy?) you have to register some or all devices.

The bottom line is that EC certification, Declaring Conformity, and Device Registration are only peripherally linked to each other.

Roland,

What I should have said is that we were certified as ISO 13485 by a notifying body, but we self certified to CE for a class 1 devices that is sterile.

So a better response would be that you need to be certifed to ISO 13485 by a notifed body before you can self declare for CE mark for Class 1 device?

The CE-marking of a Class I Medical Device without a measuring function and supplied in non-sterile condition does NOT require the involvement of a Notified Body. Conformity to the International and European Standard EN ISO 13485 is voluntary. In other words, you do not even need to be certifed to ISO 13485 if you just manufacture Class I Medical Device without a measuring function and supplied in non-sterile condition.

Persson is reinforcing my earlier answer. Your device might be Class I, Class I Measuring, Class I Sterile. The rules vary depending on what you are making.

Hi,
Can anybody help me find an independent authorized representative in UK (or EU) for CE Marking of a calss 1 device.
Thanks.

Just search keywords "authorized representative london UK", "authorized representative UK" or "medical device authorized representative UK" in Google you will find a couple of UK firms offering this service.

Persson is reinforcing my earlier answer. Your device might be Class I, Class I Measuring, Class I Sterile. The rules vary depending on what you are making.

There are good explanations and excellent graphic flow chart (Conformity Assessment Routes) at this website:
http://www.ce-marking.com/medical-devices-class-i.html