Post-Market Surveillance required by the EU's MDD vs. ISO 13485 Requirements

J

Jim-S

Regarding the post-market surveillance required by the EU’s MDD, is this requirement similar to the ISO 13485 requirements or does it go beyond them? If a company complies with ISO by compiling information regarding customer complaints & feedback, and then submits the information for review for Management Review, does this satisfy the post-market surveillance requirement?
 
V

Vitali57

Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Perhaps GHTF post marketing surveillance document under SG2 may be of help?
 

Al Rosen

Leader
Super Moderator
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

It's the same requirement. ISO 13485 is the harmonized standard used to meet the Quality system required by the MDD. This is discussed in other threads.
 
M

MDQSA

Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

It's the same requirement. ISO 13485 is the harmonized standard used to meet the Quality system required by the MDD. This is discussed in other threads.

I wouldn't completely agree with this thought. PMS in the MDD environment is meant to be more pro-active in nature than necessarily what is called out in ISO 13485. So instead of reacting to customer feedback (complaints, etc), companies should be out in the field using surveys or literature reviews or other means to collect meaningful information.
See NB-MED2.12/Rec 1 for more guidance on PMS activities for the EU
 
S

SteveK

Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

I agree with everyone.
However, my NB auditor (in 2008); covering ISO 9001, ISO13485 & 93/42/EEC, ‘strongly suggested’ an increased emphasis on post-market surveillance ‘specifically’ due to the 2007 update of 93/42/EEC. Although I’ve mentioned in another thread (I think!) how difficult it can be to get such feedback e.g. from customers (other than complaints!), I’ve tried to show I have at least attempted to address/consider this increased requirement for the next audit (partly based on clause 1.1c in Annex X, which then links to clause 8.2.1 paragraph 4 in ISO 13485). It might be repetitive/going over the top/stating the b. obvious, but I have created a top level P-M Surveillance SOP which captures our relevant lower level SOPs (Complaints, Recalls, Int. Auditing, CAPA, QM Improvement) and other indicators/reviews/forms/KPIs/questionnaires etc that we have in our QM system. So now I have a (single) flag I can wave - during a management review and/or audit.:2cents:
 

sreenu927

Quite Involved in Discussions
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Steve..

Recently we had MDD audit. One comment is to strengthen the Post Market Surveillance System. We have complaint handling SOP, FSCA, CAPA SOPs and customer feed abck form n survey results forms.

The auditor suggested to include publications, scientific literature, competitor's products, etc..and document them.

Now, I am not sure, whether to document all the abovesuggested in a word file n save in a folder or to go ahead with a PMS SOP??
If yes to SOP, could you please advise me the format for the same?

Many Thanks,
Sreenu
 
S

SteveK

Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Sreenu,

I have conducted a literature/pulication review for all the medical devices we make. These are the centre point of of my 'Clinical Evaluation' (Word format) as part of my Technical File(s). The trouble is wrt post-market surveillance is that these tend to be at least a year old if not more - so it does not make much sense. Not really thought about competitor information, but shouldn't the post market surveillance be on your own products. I suppose if there was a problem with a competitors product it would be relevant, but this would be captured in a Device Alert (a MDA, Safety Notice or Recall in the UK - available on the MHRA site) of some form (i.e. a publication again).

Steve
 

chris1price

Trusted Information Resource
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Sreenu

A few years ago, following an FDA audit, I was also asked to perform literature reviews as part of PMS. We listed in a procedure the 6 main journals (covering UK and Worldwide) we subscribed to. These were reviewed monthly for applicable papers and entered into the complaint system when appropriate. A simple spreadsheet was used to show that the reviews had taken place.

My US colleagues also performed a PubMed search on a quarterly basis looking for any papers that we had missed.

At the time, there were few internet forums, so we did not search the internet - however, today it may be more difficult to do this.

Chris
 

Al Rosen

Leader
Super Moderator
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

From the MDD.
an undertaking by the manufacturer to institute and keep up to
date a systematic procedure to review experience gained from devices
in the post-production phase, including the provisions referred to in
Annex X, and to implement appropriate means to apply any
necessary corrective action. This undertaking must include an obligation
for the manufacturer to 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
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
or performance of a device leading for the reasons referred to in
subparagraph (i) to systematic recall of devices of the same type by
the manufacturer.
Where does it say to do this on devices that someone else produces?
 
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