New Directive MDD 2007/47 - What is the status and effects?

[mpfizer]

we have recently completed surveliance audit for ce now auditors states that as per new directive 2007/47 the changes can appear only after next audit as this was done before 21March 2010? is he right

please also let me know if a new certificate has to be issued , what is the procedure?

what do we inform customers untill then ?? are we following the new directive or not ? the auditors say we are but refuses to confirm as he feels that it can only be confirmed after 21/3/2010 ??

any comments??

[suildur]

In Reply to Parent Post by mpfizer

we have recently completed surveliance audit for ce now auditors states that as per new directive 2007/47 the changes can appear only after next audit as this was done before 21March 2010? is he right

please also let me know if a new certificate has to be issued , what is the procedure?

what do we inform customers untill then ?? are we following the new directive or not ? the auditors say we are but refuses to confirm as he feels that it can only be confirmed after 21/3/2010 ??

any comments??

The auditor is right. You cannot be forced to apply requirements which arenot in force by that time. As the audit was before the required period, the audit reference has been the existing (after 21st March old) version of the directive. However, in the next audit, the new directive will be in force, so they will conduct the audit according to the new directive.

I would like to know more about what you mean with a new certificate. If you state the product and the intended use, I may tell something more.

And, the customer part... First of all, you must understand that you must apply to directives as what they tell you, because they are regulations, they are legislative documents. If a directive is coming into force on 21st March 2010, then you must apply the requirements of the directive from that date. However:

1. You already have a system which is certified and which is sustained.
2. You will fullfill the requirements of the directive from 21st March 2010 to sustain your system; otherwise, you cannot pass the next audit.
3. Your certification audit period was before 21st March 2010, which means that you will be audited on 10's of March 2011. Until then, there is a certificate which proves that you have a system which is checked and guarenteed that it is okay.

So... You will tell your customers that it is okay with your CE mark.

But, do not forget to implement new requirements until the next audit.

If you arenot satisfied with all those, then please search for something like "transition period".

[Ajit Basrur]

Refer this post from Steve on the related topic - How Directive 2007/47/EEC will affect Medical Devices industries

[somashekar]

In Reply to Parent Post by mpfizer

we have recently completed surveliance audit for ce now auditors states that as per new directive 2007/47 the changes can appear only after next audit as this was done before 21March 2010? is he right

please also let me know if a new certificate has to be issued , what is the procedure?

what do we inform customers untill then ?? are we following the new directive or not ? the auditors say we are but refuses to confirm as he feels that it can only be confirmed after 21/3/2010 ??

any comments??

I believe the NB will be interested to see during the MDD audit how an organization have mapped all the revised and new requirements and having assessed what are applicable to the organization. Having done this what target dates have been assigned and responsibility identified for actions such that planned actions are completed by the deadline, 21 March 2010.
By the application of this if you stand to be issued a new CE certificate then the same will be considered and issued in a timely manner.
Your CE certificate which is current and valid will continue unless otherwise withdrawn / suspended by the NB.

[mpfizer]

is there not a possibility that if we request the NB to audit as per new guidelines before 21st march 2010 then they are bound to do the same ?

any comments

[suildur]

In Reply to Parent Post by mpfizer

is there not a possibility that if we request the NB to audit as per new guidelines before 21st march 2010 then they are bound to do the same ?

any comments

The problem here is the legislative part. Directives are some kind of law code. Think about any legal regulation which regulates something, but that legal code is determined to be revised/changed/whatever so in some specific day; then the existing one is valid until the day comes. So, if the EU council has determined that the new directive can be applied instead of the old one before the mandatory application date (21.03.10), NBs can audit according to that, otherwise no. And, I "guess" no.

[somashekar]

In Reply to Parent Post by mpfizer

is there not a possibility that if we request the NB to audit as per new guidelines before 21st march 2010 then they are bound to do the same ?

any comments

With a full quality assurance system perhaps operational at an organization, you are expected to study, assess applicability and take actions necessary per the new guidelines within stipulated time, and in this process if you have changes to be made that are significant, you promptly report the significant changes to your NB in a timely manner and leave it to the NB to respond. Based on the merit of your significant change let the NB decide to schedule an audit or cover it in the annual MDD assessments.

[tata347]

In Reply to Parent Post by suildur

The problem here is the legislative part. Directives are some kind of law code. Think about any legal regulation which regulates something, but that legal code is determined to be revised/changed/whatever so in some specific day; then the existing one is valid until the day comes. So, if the EU council has determined that the new directive can be applied instead of the old one before the mandatory application date (21.03.10), NBs can audit according to that, otherwise no. And, I "guess" no.

you can always request an audit to see if you comply with the "new" regulation but you should be able to do the same thing yourself. You shuld be able to quickly identify if you are controlling your labeling, if there is a revision (or rev date) on the labelings (and DFU/IFU). Is your name somewhere on the product? continue down the standard. You didn't mention the type of Medical device so it may be more involved but start there.

PS...Your NB will do extra "audits" for a price, but be careful what you ask for!