Medical Device placed on the market with no CE Mark - Consequences?

[Wes Bucey]

for those too weary to read through the whole "Ethics" thread, here's a recap:

Let's recap:

• Don't whistleblow without the advice of a lawyer
• Don't commit any illegal acts in your zeal to "punish" wrongdoers
• Always protect yourself and your family

Elsewhere in the Cove, we have threads about

1. Managers who "apparently" ignore quality criteria in a regulated industry
2. Possible "bogus" ISO9k2k registration
3. Covers being "outed" and subsequently punished for remarks they made in the Cove
4. Covers losing keys and reluctant to take preventive measure to protect against burglary or injury.

What does it all boil down to?
The world can be a scary, treacherous place. It makes sense to follow Quality precepts in our lives:

• FMEA (just one way of performing risk analysis)
• Corrective/preventive action
• Customer relationship management (for each of our internal (family) and external (work and society) customers)
• PDCA - especially the part about checking [evaluating] our actions for effectiveness
• Mistake proofing - eliminate opportunities for error.

 

[MIREGMGR]

Under the specific language of the relevant UK law, who is subject to punishment if a company breaches the UK legal adoption of the MDD?

Presumably if the company is of corporate form, the corporate entity itself may be punished. The law also might incorporate the theory that the top executive is legally responsible for all decisions, and therefore might assign default responsibility to a corporation's titular senior officer or the owner of an unincorporated company.

In that case, assuming it's not your company, you're safe.

Or, does the law instead utilize the theory that punishment goes to the presumed most-senior mid-level decision maker with company-defined responsibility for relevant decisions in the matter at hand?

In that case, you're in trouble.

Or, does the law not provide for default responsibility and require an evidentiary determination of responsibility, in which more-senior personnel might argue absence of responsibility due to lack of evidenced knowledge and involvement, and therefore responsibility might be assigned to the regulatory manager due to preponderance of general evidence regarding decisions by that person of a similar nature?

In that case, you'll have legal expenses, and you'll still end up in trouble.

 

[pkost]

the MDD defines 'placing on the market' as:

means the first making available in return
for payment or free of charge of a device other than a device
intended for clinical investigation, with a view to distribution
and/or use on the Community market, regardless of whether it is
new or fully refurbished;

I think there are details which will determine how 'bad' a CA would view this...

1. Is it just placed on the market, or has it actually been sold into the EU
2. Is it labelled with a CE mark

If it has only been placed on the market and not sold then the consequences are likely to be a slap on the wrist...this happens quite often as people don't believe that offering on the web means placing on the market....the get out is the phrase..."this product is not for sale in the EU"

It it has actually been sold into the EU then this is obviously more of an issue and if there is a distributor involved then there will be consequences for them as well

If it is labelled with a CE mark then this is more willful and viewed more seriously

 

[SteveK]

Thanks for all the feedback! I should point out that this is nothing to do with me or my company. I was just made aware of this situation I described happening (in the EU). Just to recap - a medical device with no CE mark. It was just if anyone knew of anyone idiot enough to do this and what actually happened?

Steve

 

[Al Rosen]

Thanks for all the feedback! I should point out that this is nothing to do with me or my company. I was just made aware of this situation I described happening (in the EU). Just to recap - a medical device with no CE mark. It was just if anyone knew of anyone idiot enough to do this and what actually happened?

Steve

There are idiots in the US that offer Medical devices for sale all the time. It probably happens more often than you know. Here is one example and another and still another. Look at the FDA Warning Letters for more. So, why is the EU any different?

 

[recruit]

I have further questions about CE marking of accessories of device. For example, for patient monitor device with NIBP and temperature functions, NIBP cuffs and esophageal temperature probe are used with the device. According to Rule 1 and Rule 5, cuffs is Class I and temp probe is Class IIa regardless of main device. But patient monitor is Class IIb according to Rule 10. My questions are:
1. should designated cuffs and temp probe be classified with main device, as Class IIb?
2. If not, which CE marking should we stick on cuffs and probe? CE or CExxxx (xxxx means NB number).
3. when cuffs and probes only are used with designated patient monitors, and CE TF of patient monitor include them, is it necessary to create separate CE TF for them in order to issue DoC of above accessories?
I hope My questions are clear. I searched a lot the forum but no clue. My NB also have no clear answer about these questions.

 

[pkost]

1. I'm guessing that the cuffs and probes are changed regularly and considered a consumable, in which case they should be CE marked separately from the main device.

2. As they each have their own CE mark, the class 1 device should not have the NB number, the class IIa and IIb devices should

3. the TF can be put together however you like as long as it contains the required information. It can therefore contain a DoC for the class I devices and a DoC for the IIand b. It's probably even possible to combine the DoC for all devices (as long as it contained the required information)


With regards to your NB not having clear answers, do you mean they do not know or do you mean that they have not given a difinitive answer and said you can do it how you want as long as it is within the regulations? if they do not know that is rather concerning!

 

[recruit]

1. I'm guessing that the cuffs and probes are changed regularly and considered a consumable, in which case they should be CE marked separately from the main device.

2. As they each have their own CE mark, the class 1 device should not have the NB number, the class IIa and IIb devices should

3. the TF can be put together however you like as long as it contains the required information. It can therefore contain a DoC for the class I devices and a DoC for the IIand b. It's probably even possible to combine the DoC for all devices (as long as it contained the required information)


With regards to your NB not having clear answers, do you mean they do not know or do you mean that they have not given a difinitive answer and said you can do it how you want as long as it is within the regulations? if they do not know that is rather concerning!

Thank you Pkost.
Guys from our NB have different views. somebody said that accessories should be classified with main device and have same CE marking. Somebody said no. So I am so confused. I want to get idea in the cove. Who have other comments?

 

[recruit]

Further question. NB said that separate CE TF is necessary if we want to issue separate DoC for accessories. For example, Separate CE TF for NIBP cuffs, or Temp probe. In fact, CE TF of main device clearly indicates that these accessories only are used with designated main devices. In my view, a whole CE TF including main device and accessories is enough. Does anybody have comments?

 

[SteveK]

Further question. NB said that separate CE TF is necessary if we want to issue separate DoC for accessories. For example, Separate CE TF for NIBP cuffs, or Temp probe. In fact, CE TF of main device clearly indicates that these accessories only are used with designated main devices. In my view, a whole CE TF including main device and accessories is enough. Does anybody have comments?

Hi,

When I had a Technical File audit, the issue of accessories was raised. The only issue my NB raised was whether these carried CE marks themselves and this should be specifically indicated in the appropriate section of the product dossier (under Section 1: General Device Information). Note for this particular TF that a number of accessories are supplied by other suppliers (their own CE Mark), they are our own devices i.e. can be used in conjunction with (and have TFs and CE already) or they are replacement part options (no CE). We do not have a seperate DoC for accessories.

Don’t know if this helps.

Steve