Quote:
Originally Posted by jscholen
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?
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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.
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.
Independent authorized CE Marking representative in UK or EU - Class 1 Medical Device
Re: Independent authorized CE Marking representative in UK or EU - Class 1 Medical De
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